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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VIVACIT-E FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE 10MM LEFT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA VIVACIT-E FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE 10MM LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem Damage to Ligament(s) (1952)
Event Date 02/26/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: persona natural stemmed cemented tibial component 5 degree left size e catalog #: 42532007101 lot #: 63573117, persona cemented posterior stabilized narrow femoral component left size 9 catalog #: 42500006601 lot #: 63557588, persona tapered cemented stem extension 14mm x 30mm catalog #: 42557000114 lot #: 63589350. It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices are not available. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device not returned by patient.

 
Event Description

It is reported that the patient underwent a left knee arthroplasty revision to replace the polyethylene articular surface to address dissymmetry of the medial collateral and lateral collateral ligaments. A thicker articular surface was placed for the loose lateral collateral ligament. No additional patient consequences were reported.

 
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Brand NamePERSONA VIVACIT-E FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE 10MM LEFT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7790597
MDR Text Key117343649
Report Number0001822565-2018-04430
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
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42512400710
Device LOT Number63511758
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 Received02/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2016
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: 08/16/2018 Patient Sequence Number: 1
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