MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP EXTENDED LINERS; LINER 10 DEG HOODED-NEU, MP6, HXE-PLUS, 36MM

Model Number	932-36-750
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - patient had metalosis.Cup and stem stayed in patient.Liner and head were exchanged.
Additional Manufacturer Narrative
1644408-2021-00955 was reassessed and determined to be non-reportable.

• Brand Name: FMP EXTENDED LINERS
• Common Device Name: LINER 10 DEG HOODED-NEU, MP6, HXE-PLUS, 36MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12439745
• Report Number: 1644408-2021-00955
• Device Sequence Number: 11984906
• Product Code: OQG
• UDI-Device Identifier: 00190446177975
• UDI-Public: (01)00190446177975
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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 Model Number: 932-36-750
• Device Catalogue Number: 932-36-750
• Device Lot Number: 016V1076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-04-360 LOT 883B1227; 400-04-360 LOT 883B1227
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR