MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 C-STEM AMT SZ3 HI OFFSET; HIP FEMORAL STEM

Catalog Number	157014090
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Test Result (2695)
Date of Event	03/11/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
New unity record created in order to update legacy complaint number (b)(4).Asr revision to take place on (b)(6) 2013.Asr xl acetabular system - left.Reason(s) for revision: pain; alval/ soft tissue reaction - pseudo mass; elevated cobalt and chrome levels.(b)(4) reference number: (b)(4).Update nov 17, 2017: email notification from (b)(6)'s received.Updated complainant information.Doi: (b)(6) 2007, dor: (b)(6) 2013.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: C-STEM AMT SZ3 HI OFFSET
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork LS11 8 DT; EI LS11 8 DT
• MDR Report Key: 7116500
• Report Number: 1818910-2017-51608
• Device Sequence Number: 1156134
• Product Code: JDI
• UDI-Device Identifier: 10603295060307
• UDI-Public: 10603295060307
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157014090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention