MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; OPTETRAK LOGIC FIT TIBIAL TRAY, CEMENTED, SIZE 3.5F/2.5T

Catalog Number 02-012-45-3525

Device Problem Migration (4003)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 08/11/2017

Event Type  malfunction  

Event Description

It was reported by a surgeon from australia that the tibial baseplate (implant) was shifted along the medial/lateral as seen on x-ray, compared to the baseplate trial, whereas the trial was well aligned.The patient results were reported as "good" at the first post-op visit.Multiple attempts were made for information.No additional information was provided by the contacts related to this event.

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.The complaint devices were not returned for analysis.A sibling device of the tibial tray was retrieved for evaluation.The frequency of occurrence ranking is very low; therefore, this does not appear to be a design issue.A sibling device of the tibial tray was retrieved for evaluation, the device met requirements, therefore, this issued does not appear to be manufacturing-related.There is no user reported issues.A review of the risk management report (rmr) was conducted to ensure the risk was included and the occurrence is below the threshold.Corrective action is not required because the occurrence rate is "very low", and the risk is captured in the rmr.The complaint reported in experience (b)(4) was likely the result of aseptic loosening of the tibial implant, which damaged the bond of the implants to the bone.However, this cannot be confirmed because the component was not returned for evaluation.In a review of the labeling and ifu 700-096-004 rev.N, there is listed contraindication for use as patient's age, weight, or activity level that would cause the surgeon to expect early failure of the system.Only qualified surgeons are to use these products who are fully knowledgeable about all aspects of the surgical technique and use of these implants, have full knowledge about the system compatibility's, and must be fully trained to properly use the system and instrumentation.All patients should be instructed on the limitations of the prosthesis, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.There has not been a revision reported for this subsidence/migration of an implant.An investigation was conducted; the event was likely the result of aseptic loosening of the tibial implant, which damaged the bond of the implants to the bone.However, this cannot be confirmed because the component was not returned for evaluation.Information was not provided for: pt.Info.

• Brand Name: EXACTECH
• Type of Device: OPTETRAK LOGIC FIT TIBIAL TRAY, CEMENTED, SIZE 3.5F/2.5T
• 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 jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 14210207
• MDR Text Key: 299272715
• Report Number: 1038671-2022-10089
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02-012-45-3525
• Device Lot Number: 4749290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female