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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC PERSONA TMTWO-PEGGED POROUS TIBIA - LEFT SIZE D KNEE PROSTHESIS

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ZIMMER INC PERSONA TMTWO-PEGGED POROUS TIBIA - LEFT SIZE D KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Pain (1994); No Information (3190)
Event Date 12/12/2015
Event Type  Injury  
Event Description

It is reported that the pt is experiencing loosening.

 
Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unk. Surgical notes were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique. Device history records could not be reviewed as the part and lot numbers are unk. A definitive root cause cannot be determined with the info provided.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is now known that the patient was revised for unknown ongoing problems.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Manufacturer Narrative

Medical product - persona ultracongruent fixed articular surface - left 11mm, item #: 42512200411, lot #: 62590682. Persona tapered cemented stem extension - 14 mm diameter, +30 mm length, item #: 42557000114, lot #: 63177002. Nexgen tm standard primary patella, item #: 00587806535, lot #: 62617948. Persona tm cruciate retaining narrow porous femoral, item #: 42502206001, lot #: 62706192 (b)(4). 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 has now been reported that the patient underwent revision of her tibial component due to indications of loosening.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of op notes. Device history record was reviewed and no discrepancies relevant to the reported event were found. 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

Review of the revision operative notes indicates that no evidence of any significant problems on her x-ray but continued discomfort to the point where she was having as much pain as she was having preoperatively. It was felt that this was due to loosening of her tibial component. While removing tibial component, it was found that lateral peg was solidly fixed. The medial peg was not as solidly fixed as the lateral peg, and came out much easier.

 
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Brand NamePERSONA TMTWO-PEGGED POROUS TIBIA - LEFT SIZE D
Type of DeviceKNEE PROSTHESIS
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582-0708
5745273773
MDR Report Key4817843
MDR Text Key5929423
Report Number1822565-2015-00806
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 Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530006701
Device LOT Number62522564
OTHER Device ID NumberN/A
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 Received10/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/02/2015 Patient Sequence Number: 1
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