MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event: as reported, approximately two (2) years post an initial left total left knee arthroplasty, this patient was revised due to poly wear.The patella and tibial insert components were exchanged.Patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t (b)(6), 02-010-04-0220 - logic cr femoral por, left, sz 2 (b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk (b)(6), 02-012-51-2009 - logic tib insert impl crc, sz 2, 9mm.G2: (australia).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2023-01482.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified deformation/wear likely due to articulating against the femoral component while implanted and wear that is consistent with tool marks created while removing the component.Operative notes and/or medical records were not provided for review of usage/ technique.The revision reported in this event was likely the result of presumed prosthesis wear of the tibial insert and patella component.However, images of the revised components do not show signs of excessive prosthesis wear inconsistent with being implanted, no radiographs were provided, and the revised component was 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: THREE PEG PATELLA 32MM
• 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24202077
• Report Number: 1038671-2026-00080
• Device Sequence Number: 5484026
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• 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: 2021
• 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): 01/28/2026

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: 01/18/2026
• Device Catalogue Number: 200-02-32
• 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: 06/19/2023
• Initial Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 01/20/2021
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female