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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS TRABECULAR METAL 2 PEG TIBIAL COMPONENT KNEE PROSTHESIS

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ZIMMER, INC. PERSONA POROUS TRABECULAR METAL 2 PEG TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Catalog Number 42530007902
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Pain (1994)
Event Date 05/23/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient was revised due to pain and loosening.

 
Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed. The returned device had evidence of bony ingrowth and the articular surface exhibited signs of being implanted and explanted. Dhr was reviewed and no discrepancies relevant to the reported event were found. Investigation results concluded that the reported event was due to a design issue for which a recall was initiated. 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 POROUS TRABECULAR METAL 2 PEG TIBIAL COMPONENT
Type of DeviceKNEE PROSTHESIS
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
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5735472
MDR Text Key47725873
Report Number0001822565-2016-02113
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007902
Device LOT Number62186995
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/17/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1266-2015

Patient TREATMENT DATA
Date Received: 06/20/2016 Patient Sequence Number: 1
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