MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10 years post initial right tka, this (b)(6) female patient was brought back with right knee pain.Bone scan suggested loosening to both the femoral and tibial components.The insert was removed with signs of wear.The tibia was checked and found to be loose and removed.The femur checked and removed as well.Due to the large amount of bone loss on the femur, the patient received a competitor's distal femoral knee replacement.There was no breakage of device.There was a 45 minute surgical delay/prolongation.This turned into a more complicated surgery than expected due to osteolysis to the femur and tibia.Patient was last known to be in stable condition following the event.X-rays and photos received.The devices will be return.As per surgeon: "this turned into a more complicated surgery than expected due to osteolysis to the femur and tibia.".
Additional Manufacturer Narrative
Concomitant medical products: optetrak hi-flex tibial insert, sz 2, 11mm (cat# 244-22-11 / serial# (b)(4)) and cemented finned tib.Tra sz 2f/2t (cat# 200-04-22 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of femoral and tibial component loosening, which led to the pain and osteolysis reported.The prosthesis wear discovered during the revision was likely due to a combination of gross joint instability, third body wear, fatigue wear, backside wear, or any combination of these possibilities.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral and tibial components and the patient¿s bones.The most probable root cause associated with the reported event of ¿loosening¿ 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.

• Brand Name: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13713029
• Report Number: 1038671-2022-00252
• Device Sequence Number: 20400240
• Product Code: JWH
• UDI-Device Identifier: 10885862063830
• UDI-Public: 10885862063830
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: 11/28/2016
• Device Model Number: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 2, RIGHT
• Device Catalogue Number: 244-03-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female