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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA¿ VIVACIT-E® PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA¿ VIVACIT-E® PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 08/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product: femur cemented posterior stabilized (ps) standard left size 7 catalog 42500606201 lot 64186094; natural tibia cemented 5 degree stemmed left size e catalog 42532007101 lot 64293425; all poly patella cemented 32 mm diameter catalog 42540000032 lot 64197081, the product will not be returned to zimmer biomet for investigation as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported post knee arthroplasty the patient experienced procedure related complication of electrolyte imbalance of low sodium level, which required medical intervention and increased the patient¿s hospital length of stay.
 
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Brand NamePERSONA¿ VIVACIT-E®
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 Key9012042
MDR Text Key160440481
Report Number3007963827-2019-00262
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number42512400711
Device Lot Number64281984
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 Received02/26/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/13/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
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