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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS 2 PEG TRABECULAR METAL TIBIAL COMPONENT KNEE PROSTHESIS

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ZIMMER, INC. PERSONA POROUS 2 PEG TRABECULAR METAL TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Catalog Number 42530007901
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problems Pain (1994); No Information (3190)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient is alleging harm caused by the device and requires revision; however, the nature of the harm is unknown at this time.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It has now been reported that the patient revised due to pain and possible loosening.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. (b)(4).

 
Event Description

Patient underwent a left knee revision procedure approximately three years post implantation due to pain and loosening. Operative report received indicated the revision was due to mechanical loosening of the tibial component. Operative report further states that the femoral and patellar components were well fixed but the tibia was not, noting no bony growth on the tibial pegs and approximately 50% growth on the back of the tibial component. The tibia and articular surface were removed and replaced.

 
Manufacturer Narrative

Concomitant medical product: femur trabecular metal cruciate retaining (cr) standard porous, catalog #42502806201, lot #62347268. Articular surface fixed bearing cruciate retaining (cr) left 12 mm height, catalog #42512000612, lot #62380358. The reported event was confirmed through review of operative notes received. Operative notes from the revision surgery state that the patient was revised due to mechanical loosening of the tibial component. It was noted that the pegs appeared to have no bony ingrowth. The back side was noted to have 50% bony ingrowth and 50% fibrous ingrowth. The patellar and femoral components were noted to be well fixed and were not revised. Device history record was reviewed and no discrepancies were found. A field action was previously 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 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. 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 2 PEG TRABECULAR METAL 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 46582-0708
5745273773
MDR Report Key5811896
MDR Text Key50088108
Report Number0001822565-2016-02528
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 06/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007901
Device LOT Number62434344
OTHER Device ID NumberSEE H10 NARRATIVE
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 Received06/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2013
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: 07/21/2016 Patient Sequence Number: 1
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