MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML SM STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401105
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Date of Event	09/06/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: attorney.
Event or Problem Description
Litigation alleges that patient experienced severe and constant pain and suffering, swelling, bursitis, lack of mobility and/or metallosis.Update ad 12 jun 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear and elevated metal ions.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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 SM STATURE 10.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8407823
• Report Number: 1818910-2019-86899
• Device Sequence Number: 13520271
• Product Code: JDI
• UDI-Device Identifier: 10603295058205
• UDI-Public: 10603295058205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: 155401105
• Device Lot Number: ZC9FGA000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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: Other
• Patient Age: 53 YR
• Patient Weight: 69