MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK TIBIAL TRAY, FINNED, CEMENTED

Catalog Number 200-04-54

Device Problems Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision of right and left knee components due to wear of the tibial insert.

Event Description

It was reported by the patient that they experienced revision of the left knee due to tibial insert wear.No additional information is available about the event or patient.This is one of nine products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00052, 1038671-2018-00053, 1038671-2018-00054, 1038671-2018-00055, 1038671-2018-00056, 1038671-2018-00057, 1038671-2018-00059 and 1038671-2018-00388.

Manufacturer Narrative

Section d7: unknown date 2017.Section h3: the complaint products were not received for analysis.The product condition of wear and loosening were not confirmed.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design-related.The company is not aware of any other complaint reports involving parts from these manufacturing lots.A review of the device history record showed that the named devices were accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.There are no user-related issues reported.The revision reported for wear was likely due to micromotion between the implant and surrounding bone over time.Wear over time likely altered the shape and fit of the pieces, resulting in loosening.However, this cannot be confirmed because the component was not returned for evaluation."section" h6: in a review of the labeling it is a known that age, weight, 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.Aseptic loosening could be related to patient underlying conditions, such as joint maladies, as evidenced by bilateral knee replacements.There is no patient information provided to assess the patient risk/clinical factors, also there are no x-rays or surgical notes.This device is used for treatment not diagnosis.Additional information on the patient/event has been requested and not provided.

• Brand Name: OPTETRAK TIBIAL TRAY, FINNED, CEMENTED
• Type of Device: OPTETRAK TIBIAL TRAY, FINNED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7258883
• MDR Text Key: 99889335
• Report Number: 1038671-2018-00058
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K932776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/25/2008
• Device Catalogue Number: 200-04-54
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention