MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Model Number	243-02-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to loosening.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2021-01398; 243-02-106, s810-device loosening.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.Note: previous (b)(4) file is corrupted and cannot be copied, items were verified through oracle.

• Brand Name: EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8R
• 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: 17140230
• Report Number: 1644408-2023-00776
• Device Sequence Number: 1894529
• Product Code: MBH
• UDI-Device Identifier: 00190446231394
• UDI-Public: 00190446231394
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 08/24/2023

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 Model Number: 243-02-108
• Device Catalogue Number: 243-02-108
• Device Lot Number: 287W1008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 342-12-708 LOT: 122T1012; 342-12-708 LOT: UNKNOWN; 353-02-108 LOT: 203W1005A; 353-02-108 LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown