MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-26
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery.They underwent right knee revision surgery approximately 1 year 3 months after their initial procedure.Revision op report states that there was obvious evidence of oxidation of the polyethylene with yellow discoloration.There was also pitting noted in both the medial and lateral mid portion of the polyethylene.There was no evidence of any loosening of the actual components.It was also noted that the polyethylene head of the patella had some lateral edge wear and upon further inspection, it appeared that the button was placed medial and it was a small button and there was still residual patella.The surgeon noted it looked like the patella during flexion and extension, the lateral femoral condyle was riding on the edge of the patella and was tracking abnormally resulting in abnormal patella wear on the lateral edge of the patella.The patient was brought to the recovery room in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
1038671-2023-01703 d10 concomitant devices: (b)(6) 02-022-35-3509 - truliant tib imp ps insert sz 3.5 9mm.(b)(6) 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5.(b)(6) 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t.(b)(6) a10012 - gps implant kit v2.Non-exactech isoplastics.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs 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 26MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21047706
• Report Number: 1038671-2024-05094
• Device Sequence Number: 3409113
• Product Code: JWH
• UDI-Device Identifier: 10885862039576
• UDI-Public: 10885862039576
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2024

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: 07/26/2022
• Device Catalogue Number: 200-02-26
• 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: 06/21/2023
• Initial Report FDA Received Date: 12/31/2024
• Date Device Manufactured: 07/28/2017
• 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: Female