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U.S. Department of Health and Human Services

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

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ZIMMER, INC. PERSONA TWO PEG POROUS TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Pain (1994)
Event Date 05/27/2016
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: 42500006001, persona femoral cemented component, lot 62467002; 42509902525, persona hex screw, lot 62408428; 42509902548, persona hex screw, lot 62453584; 42540000032, persona all poly patella, lot 62446572; 42512400511, persona articular surface, lot 62377566; 00111314001, palacos rg bone cement, lot 78284383 qty. 2.

 
Event Description

It is reported that the patient was revised for tibial loosening after a total knee arthroplasty revision surgery.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of revision operative notes. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening. The device in question was implanted prior to this field action. The investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices. Therefore, the root cause is tied with the design of the device. 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

It is reported that the patient underwent left total knee revision surgery due to tibial loosening and pain. All component were revised and a stem extension was implanted. No further information has been provided.

 
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Brand NamePERSONA TWO PEG POROUS 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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6175366
MDR Text Key62419589
Report Number0001822565-2016-04663
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
Type of Report Initial,Followup
Report Date 10/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530006701
Device LOT Number62452076
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/24/2013
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: 12/15/2016 Patient Sequence Number: 1
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