MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TRI-LOCK BPS SZ 8 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Date of Event	08/10/2011
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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
Event or Problem Description
The patient was revised because of metal sensitivity.Doi: unknown dor: (b)(6) 2011.Update: litigation alleges metallosis and hip implant failure.Update records indicate that the patient was revised because of a pseudotumor.Update in addition to what were previously alleged, ppf alleges metal wear and elevated metal ions.Doi: (b)(6) 2009 - dor: (b)(6) 2011 (right 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.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: TRI-LOCK BPS SZ 8 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8505481
• Report Number: 1818910-2019-90464
• Device Sequence Number: 198199
• Product Code: KWA
• UDI-Device Identifier: 10603295001102
• UDI-Public: 10603295001102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2011

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: 01/01/2018
• Device Catalogue Number: 101214080
• Device Lot Number: CB5AA1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: 64 YR
• Patient Weight: 57