MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-35
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomittants: (b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm; (b)(6), 02-020-13-0230 - truliant cr cem fem cr cem left sz 3; (b)(6), 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t; (b)(6), 02-022-47-3010 - truliant tib imp cr std, size 3, 10mm; (b)(6), 200-02-35 - three peg patella 35mm; (b)(6), 204-70-00 - tibial stem ext.Screw.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported by a female patient, who had an initial left knee implant procedure in (b)(6) 2023 and had undergone a surgical procedure to repair a ¿floating kneecap¿, probably due to failed sutures according to the surgeon, indicated that 2 weeks later an x-ray indicated that the repair had failed.During a follow up on (b)(6) 2024, the surgeon stated the implant was normal.He did not know why this occurred and provided options of wearing a brace for the rest of the patient¿s life or to have the entire surgery redone.The patient indicated she no longer sees this surgeon, and they are on their 4th episode of physical therapy and will be essentially disabled the rest of their life.No further information.This is 1 of 2 events.See mdr#1038671-2025-01673 for (b)(6) 2024 event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b5, d1, d4, g4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the patella dislocation reported cannot be conclusively determined; however, it may be related to component positioning, surgical technique, and/or patient-related factors.The reported event could not be confirmed as the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported by a female patient, who had an initial left knee implant procedure and had undergone a surgical procedure to repair a "floating kneecap", probably due to failed sutures according to the surgeon, indicated that 2 weeks later an x-ray indicated that the repair had failed.During a follow up, the surgeon stated the implant was normal.He did not know why this occurred and provided options of wearing a brace for the rest of the patient¿s life or to have the entire surgery redone.The patient indicated she no longer sees this surgeon, and they are on their 4th episode of physical therapy and will be essentially disabled the rest of their life.No further information.

• Brand Name: THREE PEG PATELLA 35MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21732832
• Report Number: 1038671-2025-01690
• Device Sequence Number: 11811448
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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 Catalogue Number: 200-02-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female