MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-38
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 04026019209; (b)(6) - gps implant kit v2 (b)(6); 02-010-01-0330 - lgc femoral ps cem right sz 3.(b)(6); 201-78-15 - holding pin mini sharp point 4 pk.(b)(6); 02-012-43-3030 - lgc tibia rbktray cem sz 3f/ 3t.(b)(6); 521-78-23 - threaded pin size 2.3 collared.Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
As reported, approximately 5 years and 11 months post the initial right total knee arthroplasty, the surgeon performed a synovectomy surrounding the affected knee.Minimal osteolysis was present.The patella exhibited minimal wear along the lateral tracking path.The tibial insert was free of wear.The femoral and tibial components were well fixed.The tibial insert was removed and replaced like for like, and the patella was also replaced.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, h6, h11.The following sections were corrected: h6.No device was returned for evaluation; radiograph images were provided; however, the reported event was unable to be confirmed.The review identified that based on the pre-revision radiographs, it appears that the tibial tray may be externally rotated in relation to the femoral component.However, this cannot be confirmed from the information provided.All other aspects appear unremarkable for implanted components.Images were provided of the explanted tibial component.There does not appear to be any volumetric wear along the articular surface of the explanted tibial insert.It remains unclear whether there is wear/damage along the superior aspect of the tibial spine, or whether it is remnants of blood and/or fluid.Evaluation of the patella component for wear cannot be performed as images were not provided and the component was not revised.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 of the patella component as reported.However, this cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the patella component remains implanted and no images of the affected product were provided.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
Additional information received indicates that the patella component was not revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g.

• Brand Name: THREE PEG PATELLA 38MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23594399
• Report Number: 1038671-2025-03372
• Device Sequence Number: 9532468
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• 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: 2019
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 02/23/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2024
• Device Catalogue Number: 200-02-38
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 02/23/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/12/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• 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: 63 YR
• Patient Sex: Male