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

Model Number	200-01-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: cemented finned tib.Tra sz 4f/4t (cat# 200-04-44 / sn# (b)(4)).Three peg patella 35mm (cat# 200-02-35 / sn# (b)(4)).Cr tibial insert sz4, 9mm (cat# 200-24-09 / sn# (b)(4)).
Event or Problem Description
As reported, the (b)(6) y/o male, approximately 7 years postop the patient¿s right knee was revised due to symptomatic failure of the arthroplasty to the right knee and significant surface wear and oxidation of the polyethylene.There was advance periarticular osteolysis in the tissues, in the medical femur, and tibia effective joint space.Procedure was completed and the patient tolerated the procedure we.Patient sent to the pacu in stable condition.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was likely the result of a combination of prosthesis wear, aseptic loosening between the femoral component and the bone, and patient conditions.The loosening may have led to an increase in cement and bone particles in the joint space, which may have resulted in prosthesis wear, or prosthesis wear, secondary to kinematic conflicts, may have contributed to particle-induced osteolysis.The contribution of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation.Section (d11) concomitant devices: cemented finned tib.Tra sz 4f/4t (cat# 200-04-44 / sn# (b)(6)).Three peg patella 35mm (cat# 200-02-35 / sn# (b)(6)).Cr tibial insert sz4, 9mm (cat# 200-24-09 / sn# (b)(6)).Section(s): no information has been provided: a4, a5, and b6.The following section(s) have additional info; g4, g5, g7, h1, h2, h3, and h7.

• Brand Name: OPTETRAK
• Common Device Name: CEMENTED CR FEMORAL SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9774168
• Report Number: 1038671-2020-00229
• Device Sequence Number: 13794949
• Product Code: JWH
• UDI-Device Identifier: 10885862039545
• UDI-Public: 10885862039545
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• 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): 08/18/2020

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: 05/27/2015
• Device Model Number: 200-01-04
• Device Catalogue Number: 200-01-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR