MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 3, 10MM, VIT E; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number PS TIBIAL BEARING, SIZE 3, 10MM, VIT E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported on (b)(6) 2022 by a arthrex employee via email that tibial bearing inserts are disassociating from the tibial tray causing revisions.This was discovered during an unspecified time with no reported patient harm.

Manufacturer Narrative

Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per wi-000100100.

• Brand Name: PS TIBIAL BEARING, SIZE 3, 10MM, VIT E
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15534204
• MDR Text Key: 301092203
• Report Number: 1220246-2022-05559
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PS TIBIAL BEARING, SIZE 3, 10MM, VIT E
• Device Catalogue Number: AR-523-B310
• Device Lot Number: 5791929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other