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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT RIGHT SIZE E PROSTHESIS, KNEE

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ZIMMER, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT RIGHT SIZE E PROSTHESIS, KNEE Back to Search Results
Catalog Number 42530007102
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problems Pain (1994); Skin Discoloration (2074); Joint Swelling (2356); No Information (3190)
Event Date 06/15/2015
Event Type  Injury  
Event Description

It is reported that the pt is experiencing pain, swelling, discoloration, and a hot to the touch feeling of the knee.

 
Manufacturer Narrative

This report will be amended when out investigation is complete.

 
Manufacturer Narrative

The part and lot numbers are unknown; therefore the device history records could not be reviewed. This device is used for treatment. Surgical notes were not provided. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definitive root cause cannot be determined with the information provided.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant devices - persona trabecular metal cruciate retaining narrow porous femoral component catalog #: 42502206602 lot #: 62696218, persona cruciate retaining articular surface right 11mm catalog #: 42521000511 lot #: 62304404, nexgen trabecular metal standard primary patella catalog #: 00587806535 lot #: 62647337.

 
Event Description

It is reported that the patient underwent a right knee arthroplasty revision to address pain, swelling and tibial component loosening approximately nine (9) months post-operatively. The patient's revision operative notes relayed that the tibial component was loose and was removed very easily. The component could be lifted without significant soft tissue or bony disruption and toggled with manipulation.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records. The device history records were reviewed and no discrepancies were identified. As this device was recalled and implanted prior to the recall, the root cause is attributed to the design of the device. 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.

 
Event Description

No further event information available at the time of this report.

 
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Brand NamePERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT RIGHT SIZE E
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
po box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4826437
MDR Text Key5841232
Report Number1822565-2015-00855
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 08/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007102
Device LOT Number62584831
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/19/2014
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: 06/08/2015 Patient Sequence Number: 1
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