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

Catalog Number	208-01-03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: (cn: 204-04-33, sn: (b)(4)) trapezoid tibial tray sz 3f/3t.(cn: 208-23-11, sn; (b)(4)) cc tibial insert sz 3, 11mm.(cn: 204-34-12, sn: (b)(4)) fluted stem extension 120l x 14 mm.Pending engineering evaluation.
Event or Problem Description
Revision surgery occurred the same day, after it was discovered that the knee prosthesis (left knee) was fractured, and that patient suffered from functional impotence : surgeon decided to remove and change the prosthesis for another immediately.Revision surgery consisted thus in replacing the knee prosthesis.
Additional Manufacturer Narrative
Section h10: (h3) the engineering evaluation noted in the revision reported in experience was likely the result of the lack of required distal fixation of the femoral component relative to the bone (loosening of the femoral component), which created a bending moment on the femoral stem extension and led to fatigue fracture.(d11) concomitant devices: (cn: (b)(4), sn:(b)(4)) trapezoid tibial tray sz 3f/3t.(cn: (b)(4), sn; (b)(4)) cc tibial insert sz 3, 11mm.(cn: (b)(4), sn: 4663889) fluted stem extension 120l x 14 mm.No information provided in the following section(s): a2, a3, a4, a5, b6, and b7.The following section(s) have additional info: b4, g4, h1, h2, h3, h6, and h7.Section h11: (d10) device received on (b)(6) 2019.

• 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: 9163376
• Report Number: 1038671-2019-00495
• Device Sequence Number: 3884892
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 03/04/2023
• Device Catalogue Number: 208-01-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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