MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 5, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	244-02-05
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 4328937.200-02-35 - three peg patella 35mm 4524805.244-25-09 - optetrak hi-flex tibial insert sz 5 9mm 1773648.
Event or Problem Description
As reported, approximately 4.5 years post op the initial left tka, this male patient was revised due to implant loosening, bone loss and significant synovitis.Patient had been complaining of mechanical complications and chronic pain.Following the revision surgery, plaintiff continues to be limited in his activities of daily living, and experiences daily pain and discomfort in his left knee which limits his activities and impacts his quality of life.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of a failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface and the reported pain.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided and the device was not returned for evaluation.
Additional Manufacturer Narrative
This is 1 of 2 reports.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 cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and debonding or due to inclusion of the polyethylene in the packaging recall.A contributing factor to the reported wear on the tibial insert may have been due to the revised tibial insert having been packaged in a non-conforming bag for five years.However, the reported prosthesis wear, instability and debonding cannot be confirmed and potential contributions of 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.

• Brand Name: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 5, LEFT
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 3523771140
• MDR Report Key: 15503499
• Report Number: 1038671-2022-01188
• Device Sequence Number: 5224492
• Product Code: JWH
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2018
• Device Model Number: 244-02-05
• Device Catalogue Number: 244-02-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 02/19/2024; 04/30/2026
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 02/29/2024; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male