MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	204-22-15
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that this patient had a revision due to poly wear.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of prosthesis wear over the 9.5 years of implantation.However, this cannot be confirmed as the devices were not available for evaluation and no additional clinical information was provided.The following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8, g1, g2, h6: clinical code, type of investigation, investigation findings, investigation conclusions.The revision reported was likely the result of prosthesis wear over the 9.5 years of implantation.However, this cannot be confirmed as the devices were not available for evaluation and no additional clinical information was 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 this patient was revised approximately 9.5 years after the initial total knee arthroplasty, due to prosthesis wear.No additional information is available, and the devices were not returned for evaluation due to polywear.

• Brand Name: PS TIBIAL INSERTS SZ 2, 15MM
• 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 ct; gaiensville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15546763
• Report Number: 1038671-2022-01258
• Device Sequence Number: 1958184
• Product Code: JWH
• UDI-Device Identifier: 10885862048257
• UDI-Public: 10885862048257
• 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: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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: 05/03/2018
• Device Model Number: 204-22-15
• Device Catalogue Number: 204-22-15
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 01/27/2023; 02/18/2026
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 02/21/2023; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2010
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown