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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA ARTICULAR SURFACE FIXED BEARING (UC) RIGHT 11MM HEIGH PROSTHESIS, KNEE

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ZIMMER, INC. PERSONA ARTICULAR SURFACE FIXED BEARING (UC) RIGHT 11MM HEIGH PROSTHESIS, KNEE Back to Search Results
Catalog Number 42522200611
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported the articular surface would not lock into the tibial tray. The procedure was completed with another poly. No adverse events have been reported as a result of the malfunction.

 
Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed based on the observed damage to the returned device. An articular surface was returned and evaluated. Articular surface has multiple gouges and dents. The dovetail is flared out. The anterior slot is compressed and gouged, and the anterior surface is also gouged. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Root cause was unable to be determined. 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 ARTICULAR SURFACE FIXED BEARING (UC) RIGHT 11MM HEIGH
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6570342
MDR Text Key75317127
Report Number0001822565-2017-03321
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date04/30/2018
Device Catalogue Number42522200611
Device LOT Number62349072
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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