MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Disassembly (1168); Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Product was returned and visual examination of the returned part shows signs of repeated use, wear and missing ball bearing.Dhr was reviewed and no discrepancies relevant to the reported event were found.This device is confirmed to have been a part of a previous investigation.It was recommend against using ultrasonic cleaning as a sterilizing technique for these devices.This device was subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that this device was manufactured prior to this design change.The root cause of the reported issue is attributed to previously addressed design deficiency.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the product was returned missing one ball bearing and spring component.No adverse events were reported as a result of this malfunction.Attempts were made and no further information is available.

• Brand Name: PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7366681
• MDR Text Key: 103357337
• Report Number: 0001822565-2018-01745
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/23/2018

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 Model Number: N/A
• Device Catalogue Number: 42527900402
• Device Lot Number: 62396806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1