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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS TWO PEG TIBIAL COMPONENT OIY

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ZIMMER, INC. PERSONA POROUS TWO PEG TIBIAL COMPONENT OIY Back to Search Results
Catalog Number 42530006701
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problems Pain (1994); No Information (3190)
Event Date 11/10/2015
Event Type  Injury  
Event Description

It is reported that the patient is experiencing problems with the implant and will require revision surgery.

 
Manufacturer Narrative

Device history records could not be reviewed as the part and lot numbers are unk. No devices or photos were rec'd; therefore, the condition of the components is unk. This device is used for treatment. Surgical notes were not provided; it is unk 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

Review of the device history records for the tibial component identified no deviations or anomalies. A product history search identified no other complaints for the part and lot combination of the tibial component. A field action was conducted on (b)(6) 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. Fda recall z-1266-2015 contains the related tibial lot number. 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.

 
Event Description

It is further reported the patient was revised due to tibial loosening.

 
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 #: 42502205801 lot #: 62467473, persona fixed bearing ultracongruent articular surface 10mm left catalog #: 42512200410 lot #: 62334527.

 
Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address tibial component loosening approximately two (2) years post-operatively. The patient's revision operative notes indicate that the femoral and patellar components were well-affixed and not removed. When the tibial component was removed, fifty (50) percent of the backside of the tibia appeared to be fibrous ingrowth. No additional patient consequences were reported.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. A tibial component was returned for review. Visual inspection of the tibial component identified nicks and gouges on the surface of the device. Bone cement remains are noted on the distal surface of the device. Both the pegs have been cut off. Patient medical records were reviewed. X-ray review confirms that the components are anatomically aligned. No loosening, subluxation identified. Root cause remains attributed to design issue z-1266-2015. 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 information available at the time of this reporting.

 
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Brand NamePERSONA POROUS TWO PEG TIBIAL COMPONENT
Type of DeviceOIY
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4877579
MDR Text Key5866304
Report Number1822565-2015-01013
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
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 06/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530006701
Device LOT Number62361167
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/11/2013
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: 06/26/2015 Patient Sequence Number: 1
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