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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Unspecified Infection (1930)
Event Date 03/08/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices - persona vivacit-e highly crosslinked polyethylene fixed bearing cruciate retaining articular surface left 10mm, catalog #: 42512000610, lot #: 63716003, persona cemented stemmed tibial component left size g, catalog #: 42532007901 lot #: 63670697. Report source - foreign: (b)(6). The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Investigation incomplete.
 
Event Description
It is reported that the patient underwent a left knee arthroplasty revision to address instability. The surgeon did not have consent to properly correct the instability that was identified during the procedure, and the patient is scheduled to undergo an additional revision at a later date to fully address the instability. Revision operative notes identified that the femoral component was loose, but as no consent had been obtained from the patient, the femoral component was left in place and only the polyethylene component was replaced.
 
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Brand NamePERSONA CEMENTED CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 10
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8646681
MDR Text Key146256744
Report Number3007963827-2019-00164
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42502606801
Device Lot Number63765269
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/28/2019 Patient Sequence Number: 1
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