MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; LINER 10 DEG. HOODED NEU, MP8 HXE-PLUS, 36MM

Catalog Number	932-36-754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/27/2024
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 - due to poly wear.
Additional Manufacturer Narrative
See d4 expiration date, h4, h6, h10 and h11.Complaint has been evaluated and is similar to report number 1644408-2018-00205; 932-44-260, s805 - wear/excessive wear, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: LINER 10 DEG. HOODED NEU, MP8 HXE-PLUS, 36MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20529861
• Report Number: 1644408-2024-01650
• Device Sequence Number: 15569616
• Product Code: OQG
• UDI-Device Identifier: 00888912100175
• UDI-Public: 00888912100175
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 08/17/2023
• Device Catalogue Number: 932-36-754
• Device Lot Number: 814N1985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-363 LOT: 868B1232.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female