MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 10MM

Catalog Number	343-10-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient wound is not healing wash and changed the poly.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2021-01053, 343-10-709, s800 - revision surgery, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 10MM
• 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: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 18229382
• Report Number: 1644408-2023-01719
• Device Sequence Number: 6202565
• Product Code: JWH
• UDI-Device Identifier: 00888912171984
• UDI-Public: (01)00888912171984
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: 09/28/2023
• Device Catalogue Number: 343-10-706
• Device Lot Number: 010U1044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female