MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEETM INS, 6L 14MM, VE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	341-14-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to loosening.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01344; 341-10-707, 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
Expiration date h4 and h11.Complaint has been evaluated and is similar to previous report number 1644408-2020-00552; 341-12-707, 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: EMPOWR 3D KNEETM INS, 6L 14MM, VE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19320366
• Report Number: 1644408-2024-00670
• Device Sequence Number: 6320028
• Product Code: FZX
• UDI-Device Identifier: 00888912167031
• UDI-Public: 00888912167031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/25/2024

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: 02/27/2026
• Device Catalogue Number: 341-14-706
• Device Lot Number: 130T1076A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female