MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	12/03/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Patient was revised to address pain.Update rec¿d (3/20/2014) - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from discomfort and swelling.Update ad 24 jul 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and medical records.Ppf alleges abductor muscle repair.After review of medical records the patient was revised due to failed total hip arthroplasty and elevated metals ions level.Revision notes stated, the cup was vertical but there was no obvious subluxation, impingement or dislocation.Updated the implant date, patient identifier and the details of the impacted products.An impacted product record for the stem was added due to elevated metal ions.Doi: (b)(6) 2006 - dor: (b)(6) 2013 (right hip, first revision).Please see (b)(4) for the second revision.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML LG STATURE 10.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8932002
• Report Number: 1818910-2019-102205
• Device Sequence Number: 254358
• Product Code: JDI
• UDI-Device Identifier: 10603295058328
• UDI-Public: 10603295058328
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2013

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: 155402105
• Device Lot Number: Y1SJ5A000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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
• Patient Age: 59 YR