MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-24-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 234-02-04 - optetrak asy,ps cemented femoral, sz 4, (b)(6), 204-04-44 - trapezoid tibial tray sz 4f/4t.
Event or Problem Description
It was reported that a 69 yo female patient, initial left knee implanted in (b)(6) 2012, underwent a revision procedure in (b)(6) 2024, approximately 12 years 5 months post the initial procedure.The patient was revised due to poly wear and massive osteolysis.Everything was removed and exchanged to a competitor¿s knee.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for analysis as they were discarded by the customer.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g1 - contact email, g3, g6, h1/h2, h3, and h6 - component code, type of investigation, and investigation findings and conclusion.The revision reported was likely the result of prothesis wear which may have been due to orientation of the components, instability, patient related factors, and/or from over 12 years of use.However, this cannot be confirmed because the components were not returned for evaluation, and no radiographs or relevant clinical factors were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; 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: 1038671-2024-02549.The revision reported was likely the result of prothesis wear which may have been due to orientation of the components, instability, patient related factors, and/or from over 12 years of use.However, this cannot be confirmed because the components were not returned for evaluation, and no radiographs or relevant clinical factors were provided.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, 9MM
• 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: 19833866
• Report Number: 1038671-2024-02551
• Device Sequence Number: 18066020
• Product Code: JWH
• UDI-Device Identifier: 10885862048387
• UDI-Public: 10885862048387
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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: 04/08/2019
• Device Catalogue Number: 204-24-09
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 11/04/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 12/02/2024; 02/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female