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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC PERSONA POROUS 2 PEG TIBIAL COMPONENT

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ZIMMER INC PERSONA POROUS 2 PEG TIBIAL COMPONENT Back to Search Results
Catalog Number 42530007102
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problem Pain (1994)
Event Date 08/31/2015
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient is experiencing pain. A revision surgery is planned.

 
Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unknown. 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 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. 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 that the patient was revised due to pain and loosening of the tibial component.

 
Manufacturer Narrative

Investigation of this incident is currently ongoing. A follow-up/final report will be submitted when additional information becomes available.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. 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.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of patient's operative reports. Dhr was reviewed and no discrepancies relevant to the reported event were found. The revision operative notes indicate that the femoral and patellar components were in excellent condition, well fixed, therefore left alone. Tibial component was removed by using various saws at the bone implant interface. 50% of the back side of the implant was covered with fibrous tissue and 50% with bony ingrowth. It appeared that 1 peg and good bone ingrowth, the other one had a lot of fibrous tissue. Visual inspection of the returned tibia shows presence foreign material (bone growth/bone cement) on it. Therefore, the problem with this device constitutes a "design issue" as the root cause. 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

It is further reported that the patient was revised due to pain and loosening of the tibial component.

 
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Brand NamePERSONA POROUS 2 PEG TIBIAL COMPONENT
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 Key4994651
MDR Text Key22873843
Report Number1822565-2015-01424
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,Followup
Report Date 11/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42530007102
Device LOT Number62268128
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2018
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: 08/06/2015 Patient Sequence Number: 1
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