DATE: C. CAMPBELL, RPH CSR CCB Dear Mr. Berman, Thank you for keeping me informed of status of DePuy Hip products as they go through the FDA pipeline as well as the updates on MOM performance and the recalled ASR hips. Unfortunately my MOM patient?s clinical experience differs significantly from'the data recently reported in the Australian hip registry as well as the few published and unpublished data of Pinnacle MOM in the US. lam actively collecting and analyzing MOM statistics of the over 300 Pinnacle MOM hips that I have implanted, as well as my ASR patients. Roughly, based on revised and impending revisions (at least another I am very concerned about the increasing overall failure rate of the Pinnacle MOM implants in the selected younger population that have them. Resolution of the problem, which means revision hip surgery, has caused significant stress to and imposition of my patient?s lives and additional surgical risk. The MGM problem has greatly negatively affected my 23 year surgical reputation as patients are very angry at me for using poor quality DePuy products and they seek resolution for the problem with other surgeons even though their original surgery went extremely well. I have had a number of locally prominent individuals "jump ship" to another surgeon and clearly they will not be recommending me to anyone in the future. My data has been collected in the DePuy Captureware and DOTS clinical data base for over 10 years. This is obviously available to you as a partner in this research. i recommend you review my data. have been seeing most patients back on a yearly basis over that time period and of 660 metal-on-polyethylene hips with recent follow-up, there have been 8 revisions: 3 for stem loosening or early failure of fixation, 2 for instability, 1 for leg length discrepancy, 1 for late poly dissociation and only 1 infection. On the other hand of 262 recently evaluated Pinnacle MOM there were 17 revisions done by me, 2 revised elsewhere and at least 12 pending revisions. The diagnoses include: 7 early and most disturbingly late infections years post-op), and 10 for hypersensitivity, osteolysis, and/or pain with ALVAL type reactions. I will soon be revising a Biolox EXHIBIT We?! {7 DEPUY063019852 PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDE on Metal hip in a 42 year old with marked osteloysis pain and a massive, culture negative, effusion less than 2 years after his THR. His cup angle is 40 degrees. All patients have had the appropriate lab work for infection and ion levels, then fluoroscopically guided hip aspirations by me with fluid cell count and culture. Some patients have Co and Cr levels 10 times "normal". All x-rays have been evaluated and the cup abduction inclination has been 50 degrees or less in 80%. X-rays are available for your review. Everyday when an MOM patient comes to the office i hold my breath. I believe modular MOM disease is an epidemic of equal proportion to the ASR problem. The problems associated with these products are early and late. Perhaps the stringent follow-up protocol that my practice adheres to, wherein patients are aggressively followed-up yearly, has allowed me to indentify many patients early on the in failure pathway and has given them a platform or opportunity to discuss any issues with their hip. We then aggressively work-up the concerns whether radiographic and/or laboratory test abnormalities. I am greatly disappointed by the lack of attention and head-in-the sand response to this problem by DePuy as well as what i believe to be disingenuous reporting by surgeon-designers. I will be continuing to collect my data and plan to report this in a peer-review venue. On a very personal note, Depuy MOM products, including both Pinnacle and ASR have been a nightmare not only for my patients as above, but for my office staff, my PA and me. Just trying to be a diligent and concerned physician has required countless extra hours of work at all levels. My secretaries have to field numerous calls from patients and their families, they have spent hours scheduling the requisite tests, compiling special records and spread sheets and making new follow-up appointments. My office has had to add extra personnel to deal with the issue. My PA and have to bump new or other routine patients from my schedule to add-in the MOM hips, or add in extra hours or days. i have to cancel office hours to add-on extra surgical time to accommodate the ever increasing MOM problem. I have to endure patients wrath as a result of the need for PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063019653 PLT-00007-00002 "If additional surgery, and at it?s worse the response lost our confidence in you?. sorry doctor we have just Of course one spends an inordinate amount of time discussing the issues with the patients face to face, then, when they get home they call back for further explanation for them or their families. Many patients insist I take the time to explain the problem to their PCP, another nightmare. I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease. I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients. DePuy needs to contact physicians that have used the product and encourage them to contact their patients for an urgent follow-up. Many of our hips have osteolysis! The Company on the other hand should consider producing public service announcements or advertisements reminding patients that DePuy has 4 or 5 of the longest and best performing hip stems. We, as surgeons need some support from the Company to reassure our patients with educational materials. Many patients with non-MOM hips as well as DePuy knees are calling to question the quality of their implants as DePuy products. I would welcome a concerned and timely response from DePuy. It is becoming more and more difficult to support the use of DePuy products because of the increasing incidence of the MOM problems . John F. Irving, M.D. PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY063019854