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 Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 171 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening, prothesis wear, instability, ambulation difficulties, discomfort, joint effusion, joint laxity, osteolysis, pain, swelling/edema and synovitis.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t, (b)(6) 204-22-11 - ps tibial inserts sz 2, 11mm, (b)(6) 234-02-02 - optetrak asy, ps cemented femoral, sz 2.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00152.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and patellar loosening 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 manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information 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: 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21662653
• Report Number: 1038671-2025-01634
• Device Sequence Number: 8431534
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• 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: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2012
• Device Catalogue Number: 200-02-29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 08/23/2007
• 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: 53 YR
• Patient Sex: Female