MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO EMPOWR KNEETM, PRESS FIT BP, 11R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Catalog Number	353-02-111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to pain.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-00404; 353-01-106, 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: DJO EMPOWR KNEETM, PRESS FIT BP, 11R
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• 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: 18378925
• Report Number: 1644408-2023-01883
• Device Sequence Number: 7806124
• Product Code: MBH
• UDI-Device Identifier: 00190446230199
• UDI-Public: 00190446230199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• 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): 12/21/2023

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: 353-02-111
• Device Lot Number: 206W1033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 342-10-711 LOT: 081T1084.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male