MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	244-22-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561)
Date of Event	09/06/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 203-90-01 - 11-2624 powerpro sawblade.(b)(6), 200-02-29 - three peg patella 29mm.(b)(6), 244-03-02 - optetrak asy hi-flex ps cem fem, sz 2, right.(b)(6), 201-46-10 - holding pin headless 3"" (4 pk).(b)(6), 200-04-22 - cemented finned tib.Tra sz 2f/2t.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 9 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, instability, aseptic loosening.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: medical device problem code, component code, type of investigation.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, instability, and tibial loosening could not 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, radiographs, or relevant clinical information was provided.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19354983
• Report Number: 1038671-2024-01349
• Device Sequence Number: 18061801
• Product Code: JWH
• UDI-Device Identifier: 10885862063953
• UDI-Public: 10885862063953
• 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: 2010
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 09/23/2018
• Device Catalogue Number: 244-22-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2010
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female