MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this patient had an initial left tka on (b)(6) 2011.The patient was revised on (b)(6) 2022 due to poly issues with flaking and delamination.The surgeon replaced the patella, poly and femoral component.The patient was last known to be in stable condition.No other patient information/medical history reported.The devices are not returning as they were discarded.
Additional Manufacturer Narrative
Pending investigation.Medical devices: 234-02-03, 1991416 - optetrak asy,ps cemented femoral, sz 3, 200-02-26, 1062592 - three peg patella 26mm, 204-04-33, 2069377 - trapezoid tibial tray sz 3f/3t.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of axial rotation mismatch and mechanical overload on the medial side of the insert leading to wear of the polyethylene over the course of 11 years of implantation.However, the contributions of potential instability, loosening, and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation.H7: z-0019-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, g1, h6 (remove previous health effect-clinical code, component code, investigation findings, investigation conclusions).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 3, 9MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15407598
• Report Number: 1038671-2022-01091
• Device Sequence Number: 17616121
• Product Code: JWH
• UDI-Device Identifier: 10885862048301
• UDI-Public: 10885862048301
• 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: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 06/22/2017
• Device Model Number: PS TIBIAL INSERTS SZ 3, 9MM
• Device Catalogue Number: 204-23-09
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 01/27/2026
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/17/2022; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2009
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 80 KG