MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-23-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a patient underwent an initial total knee arthroplasty.Subsequently, the patient was revised for poly wear.No further information available.Additional information received 10/9/2025 via experience report patient id: (b)(6).Wear and tear on poly and patella as well as suspected recalled poly.Left side revision of exactech implants.Initial surgery date: (b)(6) 2008.Patient revised to exactech devices: poly and patella swap.The reported event is not related to the breakage of a device.Event did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Ebi attached.Product not returning: hospital will not release.204-23-11 - ps tibial inserts sz 3, 11mm: 1159795.200-02-32 - three peg patella 32mm: 1261548.Concomitants: 234-02-03 - optetrak asy, ps cemented femoral, sz 3: 1262258.200-04-33 - cemented finned tib.Tra sz 3f/3: 1214659.1510-s - cemex system fast 70 gm: aa1350.203-96-01 - (11-2222) saw blade new stryk (.050): 78170.
Additional Manufacturer Narrative
D10: 234-02-03 - optetrak asy, ps cemented femoral, sz 3: 1262258.200-04-33 - cemented finned tib.Tra sz 3f/3: 1214659.1510-s - cemex system fast 70 gm: aa1350.203-96-01 - (11-2222) saw blade new stryk (.050): 78.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: b, c, d the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and inclusion of the polyethylene in the packaging recall.The reported wear could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5.
Event or Problem Description
As reported, a patient underwent an initial left total knee arthroplasty.Subsequently, the patient was revised for wear of the patella and poly.The patient was last known to be in stable condition following the event.No further information available.

• Brand Name: PS TIBIAL INSERTS SZ 3, 11MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23308882
• Report Number: 1038671-2025-03120
• Device Sequence Number: 5135126
• Product Code: JWH
• UDI-Device Identifier: 10885862048318
• UDI-Public: 10885862048318
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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: 01/22/2016
• Device Catalogue Number: 204-23-11
• 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: 09/28/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 10/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/16/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2008
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female