MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; THREE PEG PATELLA 35MM

Model Number	200-02-35
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported, approximately 10.09 years since initial implant, this male patient with bmi 22.7 underwent a left side tka and was implanted with an exactech uhmwpe insert, serial # (b)(4).On (b)(6) 2021, the patient underwent revision due to aseptic loosening.No additional information is available or forthcoming.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not provided.(d10) concomitant device(s): 200-02-35, 2035253 - three peg patella 35mm section h11: *the following sections have corrected information: (d4) catalog number: 02-012-35-4015, serial number: (b)(6), expiration date: 20-may-2017, unique identifier (udi) #: (b)(4).(d10) concomitant medical products: see h10.(g4) pma/510(k)number: k033883.(h4) device manufacture date: 29-oct-2009.

• Brand Name: OPTETRAK
• Common Device Name: THREE PEG PATELLA 35MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 13450393
• Report Number: 1038671-2022-00163
• Device Sequence Number: 6199450
• Product Code: JWH
• UDI-Device Identifier: 10885862001917
• UDI-Public: 10885862001917
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 05/20/2017
• Device Model Number: 200-02-35
• Device Catalogue Number: 02-012-35-4015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• 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; Hospitalization
• Patient Sex: Male