MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-02-165
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Test Result (2695)
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
Ppf alleges metal wear, metallosis, and elevated metal ions.Doi: (b)(6) 2009 - dor: none reported (left hip).
Additional Manufacturer Narrative
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.Device history lot : lot ae8h61000 the device manufacturing record (dhr) has been reviewed.No related anomalies or deviations identified.Device history review : lot ae8h61000 the device manufacturing record (dhr) has been reviewed.No related anomalies or deviations identified.H10 additional narrative: corrected: h6 device code.

• Brand Name: AML LG STATURE 16.5MM
• 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: 8184010
• Report Number: 1818910-2018-78815
• Device Sequence Number: 11266648
• Product Code: LPH
• UDI-Device Identifier: 10603295058380
• UDI-Public: 10603295058380
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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 Expiration Date: 02/28/2016
• Device Model Number: 1554-02-165
• Device Catalogue Number: 155402165
• Device Lot Number: AE8H61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 75