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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
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Pain (1994)
Event Date 11/11/2015
Event Type  Injury  
Manufacturer Narrative

Persona femur ¿ catalogue # 42500006402; lot # 62764995. Persona articular surface ¿ catalogue # 42521400710; lot # 62846444. Persona patella ¿ catalogue # 42540000026; lot # 61631339.

 
Event Description

It is reported that the patient was experiencing pain and subsequently underwent revision due to aseptic loosening of the right knee.

 
Manufacturer Narrative

Complaint was evaluated and the reported event was confirmed. 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. The complaint components were reviewed for compatibility with no issues noted. Investigation results concluded that the reported event was due to a previously addressed design issue. 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

During the revision procedure, surgeon confirmed loose tibial component with no bony ingrowth and the presence of a slimy layer consistent with fibrous ingrowth.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The articular surface, tibial component and femoral component were returned for evaluation. Two pegs of the tibia were found to be broken. Both surfaces of the tibia exhibit foreign material and the inferior surface of the tibia exhibit dings and minor scratches. Superior side of the plastic part exhibit pitts and gouges while the inferior surface was deformed. Inferior side of the femoral component exhibit foreign material and returned parts were not in a condition to perform dimensional analysis. This information does not change the previously identified 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.

 
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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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6136546
MDR Text Key61164180
Report Number0001822565-2016-04423
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
Report Date 10/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number42530007102
Device LOT Number62657579
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberZ-1266-2015

Patient TREATMENT DATA
Date Received: 11/30/2016 Patient Sequence Number: 1
Treatment
SEE H10 NARRATIVE
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