MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	204-24-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.(b)(4).
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2013.The patient was revised on (b)(6) 2022 due to poly wear.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of wear of the tibial insert.However, the component was not returned for evaluation and no x-rays or photographs were provided.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of wear of the tibial insert.However, the component was not returned for evaluation, and no x-rays or photographs were provided.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15577203
• Report Number: 1038671-2022-01282
• Device Sequence Number: 6801150
• Product Code: JWH
• UDI-Device Identifier: 10885862048394
• UDI-Public: 10885862048394
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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 Expiration Date: 04/08/2019
• Device Model Number: 204-24-11
• Device Catalogue Number: 204-24-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 02/20/2023; 01/15/2025
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 03/03/2023; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown