MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CR TIBIAL INSERT SZ 5, 11MM, SLOPE +

Catalog Number	200-65-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Rupture (2208); Muscle/Tendon Damage (4532)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Index surgery: (b)(6) 2012.The surgeon opened the joint in standard fashion.The surgeon popped out the liner like the surgeon usually does, with a maudlin handle.The surgeon checked out the poly and noticed that it was delaminated in the deepest part of the articulating surface.The surgeon thought this was due to the patient being very hard on his knee.The patient is a very hardworking who did not take it easy on it's total knee.The surgeon also said that the patient¿s pcl had been ruptured.This was enabling the knee to shuck back and forth in a way that it wasn¿t supposed to.The surgeon decided to trial a crc, which fit very well and got rid of the shuck.The surgeon implanted the final poly, a logic crc size 5, 11 mm, and closed the joint.
Additional Manufacturer Narrative
H10: the engineering evaluation noted that the revision reported was likely the result of prosthesis wear, which may have left to instability.However, this cannot be confirmed because the device was not returned for evaluation.H11: d1 & d2: corrected brand name and common device name.G1 - changed to new manager name and contact email.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 200-02-38 - three peg patella 38mm.(b)(6) 204-04-54 - trapezoid tibial tray sz 5f/4t.(b)(6) 230-02-05 - optetrak asy, cr cemented femoral, sz 5.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.

• Brand Name: OPTETRAK
• Common Device Name: CR TIBIAL INSERT SZ 5, 11MM, SLOPE +
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobsob ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8091141
• Report Number: 1038671-2018-00899
• Device Sequence Number: 1225309
• Product Code: JWH
• UDI-Device Identifier: 10885862041142
• UDI-Public: 10885862041142
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2024

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: 10/26/2013
• Device Catalogue Number: 200-65-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 10/17/2024
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 04/01/2019; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male