MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEETM TIBIAL INSERT, SIZE 6, 12MM; MACHINED, EMPOWR 3D KNEETM INS

Catalog Number	343-12-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - pain.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-00885; 343-10-706, s807 - pain, 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 KNEETM TIBIAL INSERT, SIZE 6, 12MM
• Common Device Name: MACHINED, EMPOWR 3D KNEETM INS
• 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: 17917458
• Report Number: 1644408-2023-01410
• Device Sequence Number: 17841311
• Product Code: JWH
• UDI-Device Identifier: 00888912172226
• UDI-Public: 00888912172226
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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 Catalogue Number: 343-12-706
• Device Lot Number: 021U1017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female