MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Osteolysis (2377)
Date of Event	09/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: three peg patella 32mm (cat# 200-02-32 / serial# (b)(6)) trapezoid tibial tray sz 4f/3t (cat# 204-04-43 / serial# (b)(6)) optetrak asy, hi-flex ps cem fem, sz 4, right (cat# 244-03-04 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial right tka, the 61 y/o male had a premature polyethylene wear and delamination of insert resulting in granuloma and massive osteolysis with loosening of femoral components and significant bone defects medial and lateral femoral condyles.Patient revised to competitor's components with sleeves and stem extensions and allograft bone grafting to femur.There was no breakage of device or surgical delay/prolongation.Image received.The devices will not be returned for evaluation as it was discarded by hospital.As of note: "patient had significant bone loss at the time of revision surgery and is unlikely to return to pre-morbid level of activity".
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6, h7 and h9 have been updated accordingly.(h3 the revision reported was likely the result of polyethylene wear of the tibial insert and an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening and osteolysis.Contributing factors to the severe wear may have been the result of gross instability and being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.The most probable root cause associated with the reported 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.Also, the most probable root cause associated with the event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.Furthermore, the most probable root cause associated with the event of ¿loosening ¿ femoral¿ is associated with weakened integration of the femoral 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
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of polyethylene wear of the tibial insert and an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening and osteolysis.Contributing factors to the severe wear may have been the result of gross instability and being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the devices were not returned for evaluation 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: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
• 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 jacoboson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17126524
• Report Number: 1038671-2023-01341
• Device Sequence Number: 7322468
• Product Code: JWH
• UDI-Device Identifier: 10885862064042
• UDI-Public: 10885862064042
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 04/04/2025

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: 07/22/2018
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
• Device Catalogue Number: 244-24-11
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 08/17/2023; 04/03/2025
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/15/2023; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2010
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 89 KG