MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 11MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 3, 11MM, SLOPE +
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Discomfort (2330); Joint Laxity (4526); Joint effusion (4849)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the surveillance of medical devices of the spanish agency of medicines and health products, patient had poor clinical evolution leading to early replacement of knee prosthesis implanted on (b)(6) 2017.The tibial insert was deteriorated when removed, it was affected by the health alert sent by the company.No additional information available.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and an insufficient bond between the tibial tray and the bone which led to aseptic (non-infected) tibial loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The extent and root cause of the prosthesis wear and tibial loosening could not be confirmed as the device was not returned for evaluation, and radiographs were not provided.The most probable root cause associated with the event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Furthermore, the most probable cause associated with the event of ¿loosening - tibial¿ is associated with weakened integration of the tibial component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and an insufficient bond between the tibial tray and the bone which led to aseptic (non-infected) tibial loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The extent and root cause of the prosthesis wear and tibial loosening could not be confirmed as the device was not returned for evaluation, and radiographs were not provided.D10: (b)(6) 232-02-03 - optetrak asy, cr porous femoral, sz 3, left.(b)(6) 02-012-45-3040 - lgc tibial fit tray cem sz 3f / 4t.This follow-up report is being submitted to relay additional information.This follow-up report is being submitted to relay corrected information.

• Brand Name: CR TIBIAL INSERT SZ 3, 11MM, SLOPE +
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17595886
• Report Number: 1038671-2023-02006
• Device Sequence Number: 7421557
• Product Code: JWH
• UDI-Device Identifier: 10885862041074
• UDI-Public: 10885862041074
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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): 04/28/2025

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: 01/24/2019
• Device Model Number: CR TIBIAL INSERT SZ 3, 11MM, SLOPE +
• Device Catalogue Number: 200-63-11
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 04/23/2025
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 12/03/2023; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2011
• 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
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown