MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	244-23-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 1166624 204-04-32 - trapezoid tibial tray sz 3f/2t; 2153278 244-02-03 - optetrak asy hi-flex ps cem fem, sz 3, left; 2281733 200-02-35 - three peg patella 35mm.Recall: z-0019-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2012.The patient was revised on (b)(6) 2014, due to premature polyethylene wear of the tibial insert, causing loose components and osteolysis.No other information reported.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 13MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15543692
• Report Number: 1038671-2022-01244
• Device Sequence Number: 12406192
• Product Code: JWH
• UDI-Device Identifier: 10885862064011
• UDI-Public: 10885862064011
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 02/12/2018
• Device Model Number: 244-23-13
• Device Catalogue Number: 244-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2010
• 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: Required Intervention
• Patient Sex: Female