MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 204-23-09 - ps tibial inserts sz 3, 9mm - (b)(6), 204-04-32 - trapezoid tibial tray sz 3f/2t - (b)(6), 234-03-03 - optetrak asy, ps cemented femoral, sz 3, - (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: ,1038671-2023-00477.No device was returned for evaluation; the reported event was confirmed by review of photographs of the device.The review identified there appears to be damage consistent with delamination on the articular surface of the patella.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.The revision reported may have been the result of prosthesis wear that occurred over approximately 13.5 years of use.However, this cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Report 2 of 2 for this event.It was reported that a patient had an initial right total knee arthroplasty.Subsequently, thirteen (13) years, six (6) months later the patient underwent a right knee revision procedure due to prosthesis wear.Both the tibial insert and patella polyethylene components were replaced.The patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.

• Brand Name: THREE PEG PATELLA 29MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 25247206
• Report Number: 1038671-2026-00641
• Device Sequence Number: 10534381
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 05/19/2014
• Device Catalogue Number: 200-02-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 05/21/2009
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 80 KG