MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 13MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-62-13
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 143 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of polyethylene liner, severe osteolysis, and aseptic loosening.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Updated fields: a2, a3, b5, h6 added clinical code.D10: ((b)(6)) 230-03-02 - optetrak asy,cr cemented femoral, sz 2, ((b)(6)) 200-02-32 - three peg patella 32mm, ((b)(6)) 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t.
Event or Problem Description
It was reported via legal documentation that approximately 143 months after a right total knee replacement procedure, the patient underwent a revision procedure address pain, swelling and instability due to aseptic loosening, osteolysis and failure of the polyethylene liner.A revision operative report was provided.Intraoperatively, the surgeon observed black stained tissue, and the polyethylene was noted to be completely eroded through and had separated from the tibial base plate.The blackened tar tissue due to the metal-on-metal articulation after the polyethylene failure was removed.The femoral and tibial components were removed, and it was noted that there was a central area of bone loss in the tibia and a fairly large medial femoral condyle bone loss as well as central bone loss in the femur.No medical or surgical intervention was noted.No additional information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h11.The following sections were corrected: h6.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear, instability, disassembly, and femoral loosening, as reported, or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 2, 13MM, SLOPE +
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19515167
• Report Number: 1038671-2024-01902
• Device Sequence Number: 7195523
• Product Code: JWH
• UDI-Device Identifier: 10885862041043
• UDI-Public: 10885862041043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2014
• Device Catalogue Number: 200-62-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: Not provided; 03/25/2026
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 12/11/2024; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2009
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female