MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Test Result (2695); No Code Available (3191)
Date of Event	06/27/2012
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.Reporter is a non-healthcare professional.(b)(4).
Event or Problem Description
Litigation alleges elevated metal ions after first revision.Doi: (b)(6) 2004; dor: (b)(6) 2012; (left hip).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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.Device history lot: x83d81000.Device history batch : null.Device history review: 1 piece was scrapped from the order due to dents on the taper.2 other pieces were placed on hold for belted porocoat and scratches on the neck.These parts were split from the order per our local procedures.No other deviations or anomalies were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML SM STATURE 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8404662
• Report Number: 1818910-2019-86812
• Device Sequence Number: 16206497
• Product Code: JDI
• UDI-Device Identifier: 10603295058243
• UDI-Public: 10603295058243
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2019

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: 155401135
• Device Lot Number: X83D81000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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: 55 YR