From. Praunar, Pam [nevusr

   

To: Bolrotf. Mick Isaac. Graham 
sent: Gas/2010 5.14.06 PM
Subject: RE, nzcle COM Rems'mn
Anachments: 20m 08 2
Mick

Here rs the communication to North Tees sent rast month


From: Eorroff, 

Sent: Tuesday, September 25, 2010 5:01 AM

To: Flouhar, Pam rsaac, Graham [owes]
Subject: FW: CorarI/Pmnacle COM Revision

Pam

For dtscussron at next Med/Set call am meeting Mr Nargol tomorrow. so askto see what evtdence he has
about this

Kt nd regards


From: Antoni NagorF
Sen 27 September

To: Bormrr, Mick 

Subject: Re: Corarl/Pmnacte COM Revisron

Hi 

The guidance letter {or asr recall seems to have a confused section on exctusions Where it says fracture
neck of femur after 3 months is not . it should surely say rf evrdence of soft tissue problems then
II Is etiglble, we have clearly shown later fracture neck of femurs are due to high wear and atval Invading
bone,

Iony

From: Borrgfi' MingpEyfiaj
Sent: onday, September 27, 2010 3:56 PM
To: Antom Nargol

Cc: ch StuHOch 7 Newell Ian 
Subject: RE: Corail/Pmnacle COM Revrsion

 

Hr Tom

EXHIBIT
,9

/t 4 
As we discussed. I took forward to seeing you at 11.30 the Fracture clinic at Tees

5

 

regards


From: Amom Namel--

Sent: 24 September 2010 19:24
To: Borrufi, 

PROTECTED DOCUMENT, DOCUMENT SUBJECT TO ORDER. 

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 Chris tuiloch; Neweli, Ian 
Subject: Re: Corail/Pinnacle COM Revision

Dear Mick

iwouid be happy to meet and discuss including chris at this stage may not be necessary as i have all
his data and at a tater date you will most iikely need to meet Myself Chris and Nick Cooke and my
research team.

At this stage i think our meeting shouid be as a preliminary meeting to see what i am concerned about.
However i am concerned that we are working night day with three researchers to investigate a potential
problem. we have nothing in writing to say Depuy will fund the research following an agreement in
principle. My trust understandably feel i can not hand over any specific details until this work is at at least
agreed to be paid for.

My concerns are a believe that we are seeing a link to a failure pattern of the ASR Xl to the Pinnacle with
36 mm heads when used with metal iiners. We have revised over 34 cases some from other hospitals 
but the problem may be widespread with cases from Carlisle to Los Angeles . There is evidence of
Metal on metal and ceramic on metal failings.

With our previous history of detecting an ASR problem well before others i suspect we are two years
ahead of detecting this problem. hope i am not correct but i am hearing similar problems around the
country in initialiy smail numbers. The failure mechanism is sometimes catastrophic ARMD failure
damaging soft tissue or other wise stem loosening.

we continue to wish to work with Depuy to investigate and manage this groWing problem.
The ASR problem grows with 36% failure of femaies at 5 years.
Hope you are welt

Tony Nargol

From: Borroff. Mick 
Sent: Friday, September 24, 2010 3:36 PM
To: Tony Nargot ;Tuiloch Chris (RVW) Orthopaedics

Cc: Neweli, Ian 
Subject; Corail/?innacle COM Revision

Dear Tony and Chris

believe that lan has already spoken to you Tony to regarding my request to meet with you and Chris next week to
discuss this issue. Please find attached a letter that simpiy formallses that request. i am not available on Thursday as
i will be in London with Monday, Tuesday and Wednesday being better for me than Friday.

i took forward to seeing you.

Kind regards
Mick

Mick {Borrotf
Director of Strategic Health Outcomes
DeF?uy Orthopaedics EMEA

 

n?

mOVihg 

  

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