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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TM TWO-PEG NATURAL POROUS TIBIA KNEE PROSTHESIS

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ZIMMER, INC. PERSONA TM TWO-PEG NATURAL POROUS TIBIA KNEE PROSTHESIS Back to Search Results
Catalog Number 42530007902
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 04/15/2015
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that a patient underwent revision of a total knee arthroplasty due to aseptic loosening of the right tibial tray with collapse.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant medical product-femur cemented posterior stabilized (ps) standard right size 11 catalog# 42500607002 lot# 62767613, articular surface fixed bearing posterior stabilized (ps) right 10 mm height catalog# 42522401010 lot# 62720734, palacos rg 1x40 single catalog# 00111314001 lot# 78714386 qty 2. No product was returned; visual and dimensional evaluations could not be performed. Device history record (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. Per the packaging insert associated with the device loosening and malalignment of the device are known inherent risks of the procedure. However, a definitive 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03931, 0001822565-2017-05610, 0001822565-2017-05611.

 
Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed. Item returned and evaluation shows tibia has nicks and gouges. Foreign material was noted on most of the tm surface and bone cement was noted around the tm pegs. A prior 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 was determined to be due to 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 TM TWO-PEG NATURAL POROUS TIBIA
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6063112
MDR Text Key58613025
Report Number0001822565-2016-03931
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,Followup
Report Date 05/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007902
Device LOT Number62620499
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/21/2014
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: 10/28/2016 Patient Sequence Number: 1
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