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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA PEGGED TM TIBIAL COMPONENT KNEE PROSTHESIS

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ZIMMER, INC. PERSONA PEGGED TM TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative

Information was received via a clinical study. Concomitant products: persona cemented ps femoral, item # 42500606401, lot # 62482911; persona articular surface, item # 42512400711, lot # 62295290; persona all poly patella, item # 42540000035, lot # 62456124.

 
Event Description

It has been reported that following a total knee arthroplasty, the patient was revised due to tibial loosening.

 
Manufacturer Narrative

(b)(4). The following report is submitted to relay additional and corrected information. Reported event is confirmed through receipt of revision operative notes. No product was returned; visual and dimensional evaluations could not be performed. The revision operative notes indicated that the patient was diagnosed with tibial loosening prior to the surgery. During the procedure, the tibial component was easily removed and revealed no evidence of bony ingrowth into the trabecular metal. Review of device history records found no discrepancies relevant to the reported event. Complaint history review identified that previous action was taken due to a higher than expected prevalence of tibial loosening for the persona trabecular metal (tm) tibial plate. A field action was conducted in which 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 root cause is considered to be a previously addressed design issue. 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 PEGGED TM 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 Key6175520
MDR Text Key62418687
Report Number0001822565-2016-04637
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2017
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 Number42530007501
Device LOT Number62434360
OTHER Device ID NumberN/A
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 Received09/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/29/2013
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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