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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM PROSTHESIS, KNEE Back to Search Results
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.

 
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Brand NamePERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM
Type of DevicePROSTHESIS, 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 Key7366681
MDR Text Key103357337
Report Number0001822565-2018-01745
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK123459
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42527900402
Device LOT Number62396806
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-1052-2015

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