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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF PROVISIONAL, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); No Apparent Adverse Event (3189)
Patient Problem No Patient Involvement (2645)
Event Date 07/09/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: persona tibial articular surface provisional left size ef catalog #: 42517000505 lot #: 62752807; persona tibial articular surface provisional right size gh catalog #: 42527000505 lot #: 63797520. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-04224, 0001822565-2018-04225.

 
Event Description

It is reported that the articular surface provisionals were discovered to be fractured after surgery during cleaning. No adverse events have been reported as a result of the malfunction.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The complaint sample was evaluated and the reported event was confirmed through physical evaluation. The returned tibial articular surface provisional (tasp) exhibited signs of repeated use (nicked or gouged) and the anterior section of the post feature had fractured off with not all pieces returned. 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 tasp fractures is bending/torsional loading on the device. The fractured tasp component in this complaint was manufactured prior to the design modification. The root cause is considered to be a 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.

 
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Brand NamePERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF
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 Key7761095
MDR Text Key116369717
Report Number0001822565-2018-04223
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 OTHER HEALTH CARE PROFESSIONAL
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42527000505
Device LOT Number62868843
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2014
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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