MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4,

Model Number	230-03-04
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant medical products: cemented finned tib.Tra sz 4f/4t (cn: 200-04-44, sn: (b)(4); cr tibial insert sz 4, 9mm, slope ++ (cn: 200-74-09, sn: (b)(4).
Event or Problem Description
Femur and tibia revision to stemmed components due to implant wear and loosening.The devices will not be returned for evaluation due to patient wanted to keep implants.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of tibial insert wear and an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral and tibial components.However, this cannot be confirmed because the components were not returned for evaluation as the patient wanted to keep the implants.(d11) concomitant device(s): cemented finned tib.Tra sz 4f/4t (cn: (b)(4), sn: (b)(6).Cr tibial insert sz 4, 9mm, slope ++(cn: (b)(4), sn: (b)(6).

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9208635
• Report Number: 1038671-2019-00528
• Device Sequence Number: 336250
• Product Code: JWH
• UDI-Device Identifier: 10885862061768
• UDI-Public: 10885862061768
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 01/30/2017
• Device Model Number: 230-03-04
• Device Catalogue Number: 230-03-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention