MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CEMENTED FINNED TIB. TRA SZ 3F/2T

Model Number	234-02-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation or ¿engineering evaluation summary¿.Concomitant devices: tibial insert (cat# 204-23-09); tibial tray (cat# 200-04-32).
Event or Problem Description
As reported by the exactech knee replacement study, the (b)(6) y/o female patient was initially implanted on (b)(6) 2016.The patient experienced an left aseptic tibial loosening.Patient weighs (b)(6) lbs.Patient with clinical and radiological signs compatible with aseptic loosening of the tibial component, is taken to review the tibial component of left rtr, on (b)(6) 2020, the femoral component is stable is not reviewed, procedure without complications, discharged on (b)(6) 2020.The event is not related to the device but possibly related to the procedure.Devices not returning.All available information received at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the tibial tray.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant devices: tibial insert (cat# 204-23-09).Tibial tray (cat# 200-04-32).No information provided in the following section(s): b6, d4 (serial number and exp number), h4.
Additional Manufacturer Narrative
Section h11: (d2) common device name.(d4) catalog number changed to 200-04-32, and udi number updated.(d11) concomitant devices updated to; tibial insert (cat# 204-23-09).Femoral (cat# 234-02-03).(g5) 510k number updated to k932776.

• Brand Name: OPTETRAK
• Common Device Name: CEMENTED FINNED TIB. TRA SZ 3F/2T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9700049
• Report Number: 1038671-2020-00072
• Device Sequence Number: 2001684
• Product Code: JWH
• UDI-Device Identifier: 10885862063199
• UDI-Public: 10885862063199
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2020

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 Model Number: 234-02-03
• Device Catalogue Number: 200-04-32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 03/18/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/10/2020; 04/16/2020
• 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
• Patient Weight: 60