MAUDE Adverse Event Report: EXACTECH, INC CEMENTED FINNED TIB. TRA SZ 3F/3T; TRAY

Catalog Number 200-04-33

Device Problems Material Erosion (1214); Pitted (1460)

Patient Problem Joint Disorder (2373)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

The complaint devices were received for analysis.The condition of prosthesis wear was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) tibial tray- appears to have biological material adhered to the surface consistent with bone cement, this indicates that the tibial tray was securely fixed to the bone.The scratches appear consistent with mating with the tibial insert, there may have been some micromotion between the two components.Deformation on the posterior lateral edge of the tray appears that the lateral femoral condyle contacted the posterior lateral edge of the tray following the wear and material loss of the tibial insert.Tibial insert - the wear and loss of material appears consistent with femoral articulation on the posterior lip of the tibial insert.Pitting appears consistent with third body wear, it is on the backside of the insert as well as the medial articular surface.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company is not aware of any other complaint reports involving parts from either of these manufacturing lots.A review of the device history record for the tibial insert showed that the named devices were accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.The revision reported was likely the result of excessive overall posterior tibial slope of the tibial insert, which allowed for excessive posterior contact between the femoral component and the tibial insert, especially laterally, leading to wear and material loss of the polyethylene.There is no patient information provided to assess the patient clinical/risk factors.In a review of the labeling, it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure and that fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, may require a second surgical intervention or revision.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.Patients must be informed that their weight and activity level may affect the longevity of the implant.It is a known risk of total joint surgeries that there may be the need for surgical revisions or interventions for different causes and conditions.This device is used for treatment not diagnosis.For the investigation of this event, information has been requested.No new information has been provided.

Event Description

It was reported that a patient experienced a revision knee surgery for prosthesis wear.The poly was successfully replaced and the patient was stable leaving the or.No additional information has been provided on the patient or event.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2016-00807 and 1038671-2019-05029.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 3F/3T
• Type of Device: TRAY
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; 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: 8594695
• MDR Text Key: 144543317
• Report Number: 1038671-2019-05029
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/14/2017
• Device Catalogue Number: 200-04-33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention