MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR PS KNEETM FEMUR, NONPOROUS, 7L

Catalog Number	242-01-107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to loose femoral component.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2019-01171; 242-02-107, s810 - device loosening, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Additional Manufacturer Narrative
See d10, h10, and h11.Complaint has been evaluated and is similar to report number 1644408-2019-01171; 242-02-107, s810 - device loosening, 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: EMPOWR PS KNEETM FEMUR, NONPOROUS, 7L
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758-5445 ; 5128346313
• MDR Report Key: 20872944
• Report Number: 1644408-2024-01859
• Device Sequence Number: 8831304
• Product Code: JWH
• UDI-Device Identifier: 00888912171779
• UDI-Public: 00888912171779
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/09/2025

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: 07/24/2026
• Device Catalogue Number: 242-01-107
• Device Lot Number: 860T1202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2020
• 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: 130-03-738 LOT 157N1370; 130-03-738 LOT: 157N1370; 343-10-707 LOT: 011U1023; 343-12-707 LOT 022U1001; 351-01-107 LOT 983R1133; 351-01-107 LOT: 983R1133
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male