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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH PROVISIONAL, KNEE

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ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH PROVISIONAL, KNEE Back to Search Results
Model Number N/A
Device Problems Crack (1135); No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the provisional cracked during removal. The surgery was completed successfully with another device. No adverse events have been reported as a result of the malfunction.

 
Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation. The returned device showed signs of repeated use (nicked/gouged) and was fractured on the lateral side of the post. The device history records were reviewed and no discrepancies were identified. A corrective and preventative action investigation into this issue determined that the likely root cause for the tibial articular surface provisional (tasp) fractures is bending/torsional loading on the device. Ps tasp top components and standard (non-cps) tasp bottom components have been modified to prevent fracture. This device was manufactured prior to the design modification and therefore the root cause is the previously addressed design issue. 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

No further event information available at the time of this report.

 
Search Alerts/Recalls

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Brand NamePERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH
Type of DevicePROVISIONAL, 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 Key7771812
MDR Text Key116712928
Report Number0001822565-2018-04287
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42517000707
Device LOT Number62601574
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-2297-2014

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