MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-2511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.The reason for the reported revision event cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, instability and loosening cannot be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images or radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported via legal document, revision operative report, a patient, had a failed right total knee replacement refractory to conservative management.The patient was indicated for surgery.A thorough synovectomy was performed.There was a fracture at the proximal tip of the femoral component stem which was visualized and cleaned up.The femoral fracture was reduced with pointed reduction clamps.Freshening cuts were made to the femur.They were able to obtain an anatomic reduction of the fracture which was stable with the strut in place.The femoral implant was removed with minimal bone loss.The tibia was intact and well fixed.New femoral component and insert were implanted.The patient was transferred to the recovery room in stable condition.There is no mention of any defects to the polyethylene liner in this operative report.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.Additional information indicated the patient underwent surgery on her right knee and was implanted with a recalled optetrak polyethylene tibial insert (serial #: (b)(6).The patient underwent right knee revision surgery due to accelerated and preventable wear of the optetrak polyethylene tibial insert, approximately 5 years post the initial procedure.The legal claim states polyethylene wear, the revision operative report has no mention of any defects or problems with the polyethylene.The patient had a femoral bone fracture that was repaired.The report indicates the patient suffered andwill continue to suffer serious personal injuries, including pain, impaired mobility, rehabilitation, medical care, loss of enjoyment of life, and other medical and non-medical sequalae.No further information.This is 1 of 2 reports for this event.

• Brand Name: OPTETRAK LOGIC
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25075746
• Report Number: 1038671-2026-00535
• Device Sequence Number: 10695600
• Product Code: JWH
• UDI-Device Identifier: 10885862173522
• UDI-Public: 10885862173522
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 09/08/2019
• Device Catalogue Number: 02-012-44-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female