MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CC FEMORAL SZ 3

Model Number	208-01-03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): stem extension 80l x16 mm (cat# 204-36-08).Cc tibial insert sz 3, 13mm (cat# 208-23-13).Trapezoid tibial tray sz 3f/3t (cat# 204-04-33).Cc distal fem augment sz 3, 5mm (distal) (cat# 208-05-03).Cc distal fem augment sz 3, 5mm (posterior) (cat# 208-08-03).Tibial stem extension 120l x10 mm (cat# 204-30-12).Tibial augment block 1/2-sz 3 11mm llrm (cat# 204-63-89).Three peg patella 35mm (cat# 200-02-35).
Event or Problem Description
As reported by the knee replacement study, the patient experienced breaking of the tibial implant.The event is unlikely related to the device and to the procedure.
Additional Manufacturer Narrative
Please disregard this submission as it was found to be a duplicate of the following mfr's numbers; 1038671-2017-00363, 1038671-2017-00422, and 1038671-2017-00423.

• Brand Name: OPTETRAK
• Common Device Name: CC FEMORAL SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9457081
• Report Number: 1038671-2019-00596
• Device Sequence Number: 19602327
• Product Code: JWH
• UDI-Device Identifier: 10885862053220
• UDI-Public: 10885862053220
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 208-01-03
• Device Catalogue Number: 208-01-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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 Age: 71 YR
• Patient Weight: 72