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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TIBIA TRABECULAR METAL FIXED BEARING RIGHT SIZE F PROSTHESIS, KNEE

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ZIMMER, INC. PERSONA TIBIA TRABECULAR METAL FIXED BEARING RIGHT SIZE F PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 05/04/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Medical product: catalog #: 42502207002, femur trabecular metal cruciate retaining (cr) narrow porous, lot # 71794257, 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. The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not. Once this information is obtained a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03849-1. Product location unknown.

 
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 tibial components was grossly loose, and there was no infection evidence. 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. 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 capa investigation determined that the likely root cause as 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 TIBIA TRABECULAR METAL FIXED BEARING RIGHT SIZE F
Type of DevicePROSTHESIS, KNEE
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 Key6744275
MDR Text Key81060272
Report Number0001822565-2017-05173
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,Followup
Report Date 03/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number42530007502
Device LOT Number62519942
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 Manufactured02/07/2014
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: 07/26/2017 Patient Sequence Number: 1
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