MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-03-04
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: 1380052 200-74-09 - cr tibial insert sz 4, 9mm, slope ++; aa3614 13a2101 - cemex system fast genta 70g; 1718264 200-02-38 - three peg patella 38mm; 1768636 200-04-44 - cemented finned tib.Tra sz 4f/4t; 1711837 201-78-14 - holding pin headless sharp point long 4pk; 1752052 201-78-15 - holding pin mini sharp point 4 pk; 1308 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19; 1701713 230-03-04 - optetrak asy,cr cemented femoral, sz 4,; aa3328 asa0030 - sterile disposable containers.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 140 months after a total replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, swelling, osteolysis, synovitis.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: d6a, h6.Mdr section codes updated/corrected: a, b, e, g.The revision reported was likely the result of pain, loss of range of motion, aseptic loosening, and instability.The loosening may have been caused by improper component sizing and alignment, which led to an increase in cement and bone particles in the joint space and prosthesis wear.However, the contributions of loosening, prosthesis wear, component alignment and the sequence of events cannot be determined as the devices were not available for evaluation and radiographs from the index surgery were not available.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4,
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20290759
• Report Number: 1038671-2024-03673
• Device Sequence Number: 7171539
• Product Code: JWH
• UDI-Device Identifier: 10885862061768
• UDI-Public: 10885862061768
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2015
• Device Catalogue Number: 230-03-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 03/04/2025
• Date Device Manufactured: 03/25/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male