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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VIVACIT-E POSTERIOR STABILIZED ARTICULAR SURFACE 11MM RIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA VIVACIT-E POSTERIOR STABILIZED ARTICULAR SURFACE 11MM RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Damage to Ligament(s) (1952)
Event Date 05/27/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical devices - unknown persona femoral component catalog #: ni lot #: ni, unknown persona tibial component catalog #: ni lot #: ni. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device evaluated by manufacturer? investigation incomplete.

 
Event Description

It was reported the patient underwent a right knee arthroplasty revision to address ligamentous instability approximately two (2) years post-operatively. The articular surface was removed and replaced. It was verified by the surgeon that no additional information is available.

 
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Brand NamePERSONA VIVACIT-E POSTERIOR STABILIZED ARTICULAR SURFACE 11MM RIGHT
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 Key10179768
MDR Text Key195954321
Report Number0001822565-2020-02177
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK121771
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 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522400711
Device LOT Number63418220
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 Received06/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2016
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: 06/22/2020 Patient Sequence Number: 1
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