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U.S. Department of Health and Human Services

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

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ZIMMER, INC. PERSONA POROUS TWO PEG TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Catalog Number 42530006701
Device Problems Failure To Adhere Or Bond (1031); Unstable (1667)
Patient Problem No Information (3190)
Event Date 02/09/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the after a knee arthroplasty, the patient was revised due to instability and tibial component subsidence.

 
Manufacturer Narrative

Concomitant medical products: item name: persona femal trabecular metal cr narrow, item number: 42502206601, lot number: 62718155. Item name: persona articular surface cr, item number: 42512000410, lot number: 62559445. Item name: nexgen tm patella, item number:. 00587806532 , lot number: 62708947. Reported event was unable to be confirmed due to limited information received from the customer. 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 as no were trends identified. The devices were evaluated for compatibility with no issues found. Per the packaging insert associated with the device malignment and instability of the knee components are a known inherent risk of the procedure. However, a root cause cannot be determined 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.

 
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Brand NamePERSONA POROUS TWO 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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6033305
MDR Text Key57618383
Report Number0001822565-2016-03698
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530006701
Device LOT Number62534804
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 Received07/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/17/2016 Patient Sequence Number: 1
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