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U.S. Department of Health and Human Services

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

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ZIMMER, INC. PERSONA POROUS 2 PEG TIBIAL COMPONENT KNEE PROSTHESIS Back to Search Results
Catalog Number 42530006702
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 07/27/2015
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient was revised due to a failed total knee arthroplasty involving a tibial component alleged to have been involved in a recall.

 
Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed. The device history records for the tibial component were reviewed and no deviations or anomalies were identified. A review of the compatibility matrix was performed. This device is used for treatment. The primary surgical notes state that the patient underwent tka to treat severe degenerative joint disease of the right knee. Bony cuts were performed, osteophytes removed, and the trial components were inserted. Releases of the popliteus and lateral retinaculum were required to achieve acceptable extension and flexion, well-balanced gaps, and excellent tracking of the patella. The final components were implemented using a cementless technique. Range of motion and stability were rechecked and found to be excellent with well-balanced gaps and acceptable patellar tracking. No intraoperative complication noted. The revision surgical notes state that the patient was revised 13 months post surgery due to a failed right tka associated with the recalled tibial component. Intra-operatively the synovial fluid was found clear and cultures were negative for infection. The tibial component was removed using a saw and osteotomes. Fifty percent of the tibial component appeared to have bone ingrowth and 50 percent was fibrous; the pegs were well ingrown. The femoral and patellar components were well fixed and left alone. A field action was conducted on february 19, 2015 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 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. Therefore, the problem with this device constitutes a "design issue" as the root cause.

 
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Brand NamePERSONA POROUS 2 PEG 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
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5729524
MDR Text Key47533281
Report Number0001822565-2016-02073
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530006702
Device LOT Number62438473
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/08/2013
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: 06/16/2016 Patient Sequence Number: 1
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