MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 5, 9MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-65-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
These devices are used for treatment not for diagnosis.There is no other information available.Optetrak asymmetric cr femoral component (230-02-05, 2284707) optetrak trapezoid tibial tray (204-04-54, 2316793) cem patella (200-02-38, 2388524) optetrak cr tibial insert (200-65-09, (b)(6).Exactech cemex bone fast trak.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2012.Approximately 5 years and 2 months after the initial procedure the patient had a right knee revision on (b)(6) 2017.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.Serial radiographs and bone scan demonstrate increased uptake in the distal femur and tibia with wear of the polyethylene component.Surveillance labs with cbc, esr and crp were within normal limits.Right tka aseptic loosening with extensive metallosis.¿there was extensive metallosis within the knee joint.There was no gross purulence.¿ the patient was taken to recovery in stable condition.Revision right tka.The patient was revised to competitor's devices.No other information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear and instability could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 5, 9MM, SLOPE +
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19126467
• Report Number: 1038671-2024-00894
• Device Sequence Number: 12851958
• Product Code: JWH
• UDI-Device Identifier: 10885862041135
• UDI-Public: 10885862041135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 11/08/2018
• Device Catalogue Number: 200-65-09
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2010
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male