ZIMMER BIOMET Your progress. Our promise? Urgent Field Safety Notice Product: M2a 38mm Acetabular System Product reference: All cups and heads in Attachment 1 Reference: FSCA20160307 Advisory Notice Date: April 12, 2016 Attention: Dear surgeon This letter is to inform you of a voluntary Field Safety Corrective Action (FSCA) in relation to the M2a 38mm Acetabular System, manufactured by Biomet Orthopedics LLC, Warsaw, lndianalUSA and Biomet UK Ltd, Bridgend, UK (hereafter called Zimmer Biomet). After discussion with the MHRA, Zimmer Biomet has initiated this Field Safety Corrective Action following on?going analysis of data collected by the National Joint Registry (NJR) for England, Wales and Northern Ireland which revealed that this hip system has a higher than expected revision rate. Our records indicate that some of your patients may have received this M2a 38mm Acetabular System. Action to be taken: While the M2a 38mm Acetabular System has not been marketed in Europe since December 2012 due to changing market demands and low product utilisation, this Field Safety Notice (FSN) is intended to make clinicians and healthcare professionals aware of the MHRA guidance dated June 25, 2012 regarding the follow-up of patients implanted with metal on metal hip replacements, with the aim of enhancing the clinician?sihealthcare professional?s awareness of the guidance provided by the MHRA on patient management in general and to reinforce its application to all patients treated with the M2a 38mm Acetabular System. Zimmer Biomet encourages clinicians and healthcare professionals to continue to monitor their M2a38mm patients in accordance with this MHRA guidance. The details in the Appendix to are as follows over the page: Page 1 or 5 ZIMMER BIOMET Your progress. Our. premiers: Stemmed MOM-total hip replacements femoral head diameter 236mm patients patients Patient follow-up Annually for the life of the Annually for the life of the implant implant Imaging: MARS MRI or Recommended in all-Easies Recommended if blood metal ultrasound - ion levels rising 1st blood metal ion level YES 4 YES test Results of 1st blood metal Blood metal ion level >7ppb_ If blood metal-ion Eve?l ion level test indicates potential for soft >7ppb then second blood tissue reaction test required 3 months later 2nd blood metal ion level Yes 3 months after 1le Yes - 3 months after let - test blood test if result was >7ppb blood test if result was >7ppb Results of 2nd blood metal Blood metal ion level >7ppb If blood metal ion levels ion level test indicates potential for soft ?Sing - Wither tissue reaction especially if requ?red mC/Udmg ?magmg greater than previously Consider nee?d for revision_ if imaging is abnormal and/or If imaging is abnormal and/or blood metal ion levels rising metal i0? leVelS ?Sing The Appendix to continues: "Table footnotes: - Blood metal ion testing to be in whole blood - 7 parts per billion (ppb) equals 119 nmol/L cobalt or 134.5 nmol/L chromium" Guidance notes: - On the basis of current knowledge, this chart has been produced as a guide to the management of these patients. It will not necessarily cover all clinical situations and each patient must bejudged individually. - MARS MRI scans (or ultrasound scans) should carry more weight in decision making than blood metal ion levels alone. 0 Patients with muscle and/or bone damage on MARS MRI are those of most concern. A fluid collection alone around thejoint in an patient, unless it is very large can be safely observed with interval scanning. - Local include pain and limping. Page 2 of 5 ZIMMER BIOMET Your progress. Our promise." Zimmer Biomet is not advising that patients should be proactively revised unless this is required in the clinical judgment made by the patient?s clinician. Each patient should be considered in the light of their individual clinical situation. While Zimmer Biomet encourages clinicians and healthcare professionals to continue to monitor their M2a 38mm patients in accordance with the MHRA guidance detailed in it is aware that certain regulatory authorities as well as national associations of orthopedic surgeons have issued individual patient follow-up programs for their local markets. it is the clinicians and healthcare professionals responsibility to select the appropriate patient follow-up program based on local clinical practices and local regulations. Transmission of this Field Safety Notice: This FSN needs to be passed on to all those who need to be aware within your organisation or to any other organisation to which the devices concerned have been transferred. Please maintain awareness of this FSN and resulting action for an appropriate period to ensure effectiveness and ensure that you follow the most recent version of the guidance issued Please complete and return the attached ?Certificate of Acknowledgement" on page 4 of this FSN to your local ZimmerBiomet distributor by April 22, 2016. This confirms the fact that you have received, understood and implemented this FSN. Any adverse events or quality problems experienced with the use of this product or any other products should be reported to your local Zimmer Biomet distributor and your local responsible competent authority. Please contact your local Zimmer Biomet distributor if you may have any question regarding this Notice. Yours sincerely Natalie Wide Director Biomet UK and authorised representative for Biomet Orthopedics LLC. Waterton Industrial Estate Bridgend South Wales CF31 3XA Page 3 of5 ZIMMER BIOMET Your progress. Our premlee.? Certificate of Acknowledgement ATTENTION: (Local Zimmer Biomet Distributor) Email: (Local Zimmer Biomet Distributor) Fax: (Local Zimmer Biomet Distributor). Regulatory Action: URGENT FIELD SAFETY NOTICE Description: M2a 38mm Acetabular System By signing the below, i confirm that haVe received and understand and have implemented this URGENT FIELD SAFETY NOTICE. Printed Name: Title: Facility Name: Facility Address: Telephone: Signature: Date: Page 4 of5 ENT 1 ZIMMER BIOMET Your prawn Our promise: Device details: M2a 38mm Cementless Cups and M2a 38mm Modular Heads 11473664 11473665 144380351 14-380352 Ill-330353 14-35035? 15-105 048 15-105 050 15-105 052 15- 105056 15- 15-105060 15-105062 15-106070 00118850 HD113852 RD118854 RD118856 RD118858 RDJISBEZ [10118066 R0116870 CP161005 CP161007 CP CP161009 CP161073 IS-IDEOEDHA Item M2A aaMM MOD HD NK MOD -3MM NK NK MZA MODLR HEAD MZA MODLR HEAD M2A MODLR HEAD DIABBMM +5.5 MZA MODLR ?5 MZA HEAD DIASEMM +10.0 MZASBMM ONEPIECE MZA 38MM ONE PIECE CUP SZ 50MM MZA 38MM ONE PIECE MZA BBMM ONE PIECE CUP SZ MZA BBMM ONE CUP SZ56MM CUP MZA HBMM CUP SZ 52 M2A SBMM ONE PIECE CUP 52 64MM SBMM ONEPIECE CUP 66MM MZA SSMM ONE PIECE CUP SZ ESMM MZA ONE CUP 70MM CUP CUP NON FLARED MIA-38 SZMM CUP NON FLARED CUP NON FLARED NON CUP NON CUP NON FLARED CUP NON FLARED CUP CUP FLARED CUP NON FLARED CUP NON FLARED MZA-SE CUP SZMM CUP 54MM CUP CUP M21168 SOMM MZA 38X64MM CUP MZA CUP BBXESMM CUP MM CUP 53 38 TRISPIKE HAP 38 2-18 POR HAP 38 38 TRISPIKE MZA 38 TRISPIKE M-ISESMM 38 38 CUP NON FLARED SZ 38 CUP MZA-SB CUP NON FLARED 52 SZMM CUP NON FLARED NON SZ SSMM CUP FLARED CUP NON FLARED SZ EDMM Page 5 of 5