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U.S. Department of Health and Human Services

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

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ZIMMER, INC. PERSONA TWO PEG POROUS TIBIAL COMPONENT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)
Patient Problems Inadequate Osseointegration (2646); No Information (3190)
Event Date 02/23/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient is experiencing unknown injury due to the implant.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial report. Concomitant products: item # 42500807001, persona tm standard femoral, lot # 62688449; item # 42512401010, persona ps ve articular surface, lot # 62706147; item # 42540200035, persona ve all poly patella, lot # 62826593.

 
Event Description

It has now been reported that the patient was revised due to tibial loosening.

 
Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information. Corrected: common device name and product code. Reported event was confirmed through review of medical records. Review of device history record found no discrepancies relevant to the reported event. Root cause of the event is attributed to the design of the device, which has been the subject of a previous corrective action. It was determined that this device was manufactured prior to the corrective action. No further action is required at this time. 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

Additional information received in revision operative report indicates failed right uncemented total knee arthroplasty secondary to failed bony ingrowth of the tibial component.

 
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Brand NamePERSONA TWO PEG POROUS TIBIAL COMPONENT
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
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5688405
MDR Text Key46183957
Report Number0001822565-2016-01818
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 08/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007901
Device LOT Number62600891
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2014
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: 05/31/2016 Patient Sequence Number: 1
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