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

Catalog Number	155402135
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Local Reaction (2035); Test Result (2695); No Code Available (3191)
Date of Event	03/02/2018
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
Asr medical records received.After review of medical records the patient was revised due to pain and elevated metal ions.Operative note reported straw colored fluid present in the joint and slightly murky consistent with adverse reaction to metal debris, hypertrophic synovium, pseudotumor, hemosiderin stain, metal staining and some trunnionosis.There was some trunnoinosis and metal debris on the trunnion itself.Another event was reported a competitor head would not stay on the trunnion due to adaptor sleeve size was the wrong size to fit on the trunnion.However, decided not to removed the well fixed stem which may add another hours to the case.The head component that did not fit appropriately during revision was temporary left in the patient and proceeded to a second stage procedure to re-implant the correct sized femoral head (competitor).Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML LG STATURE 13.5MM
• 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: 9416803
• Report Number: 1818910-2019-120743
• Device Sequence Number: 2579655
• Product Code: JDI
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 155402135
• Device Lot Number: Z5BHS1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: 68 YR