MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 41MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-41
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-01205 d10: (b)(4), 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm; (b)(4), 02-010-01-0250 - logic femoral ps cem left sz 5; (b)(4), 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.The product associated with the reported event is within the scope of recall [z-0582-2024]; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01205.The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be femoral loosening, instability, and inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not 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
It was reported that approximately 114 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, ambulation difficulties, joint effusion, joint laxity, discomfort, osteolysis, swelling/edema and pain.No further issues or complications were reported.No additional information is available.

• Brand Name: THREE PEG PATELLA 41MM
• 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: 21344693
• Report Number: 1038671-2025-00784
• Device Sequence Number: 18382399
• Product Code: JWH
• UDI-Device Identifier: 10885862039620
• UDI-Public: 10885862039620
• 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: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 06/02/2019
• Device Catalogue Number: 200-02-41
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male