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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS RIGHT SIZE 11 KNEE, PROSTHESIS

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ZIMMER, INC. PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS RIGHT SIZE 11 KNEE, PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)
Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 05/04/2015
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It was reported that the patient underwent a right knee total revision procedure due to aseptic loosening.

 
Manufacturer Narrative

(b)(4). Concomitant medical product: catalog #: 42530007502, persona tibia trabecular metal fixed bearing right size f, lot # 62519942 catalog #: 42522200510, articular surface fixed bearing ultracongruent (uc) right 10 mm height, lot # 62277120, catalog #: 42540000038, all poly patella cemented 38 mm diameter, lot # 62666612, catalog #: 42502207002, persona femur trabecular metal cruciate retaining narrow porous right size 11, lot # 62639674, catalog #: 00597909541, patella reamer blade with pilot hole 41 mm diameter single use only, lot # 62740784, catalog #: 20807000202, persona jigs aref & tibia rotation right, lot # 62885678, catalog #: 200100000, universal disposable drill and pin set 3 in pins(4), 5 in pin(1), 5 in drill(1), lot # 62885678. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-05173.

 
Event Description

It was reported that patient underwent a revision procedure due to aseptic loosening approximately six months post implantation. It was noted that the patella was well fixed, femoral component was not grossly loose, but was easily removed, and the tibial component was grossly loose. The patient had a preoperative flexion contracture of around 20 degrees. Attempts have been made and additional information on the reported event is unavailable at this time.

 
Manufacturer Narrative

(b)(4). The following report is submitted to relay additional information. The reported event is confirmed; operative notes of revision surgery identified that the tibial component was grossly loose and there was no evidence of infection. The patient also had preoperative flexion contracture of around 20 degree so the femoral component was also revised. During the surgery it was observed that femoral component was not grossly loose. No devices or photos were received; therefore, the visual and dimensional evaluations could not be performed. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Compatibility of the following components was assessed with no issues identified. Review of the complaint history determined that no further action(s) is/are required. 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 tibial component in question was implanted prior to this field action. 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. The root cause of the loosening is determined to be a previously addressed design issue. The root cause of the flexion contracture could not be determined. 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.

 
Manufacturer Narrative

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 FEMUR TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS RIGHT SIZE 11
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
kathleen smith
p.o. box 708
warsaw, IN 46580
8006136131
MDR Report Key6061997
MDR Text Key58598578
Report Number0001822565-2016-03849
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK122745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number42502207002
Device LOT Number62639674
OTHER Device ID NumberN/A
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 Received03/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/16/2014
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: 10/27/2016 Patient Sequence Number: 1
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