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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA VIVACIT-E MEDIAL CONCGRUENT ARTICULAR SURFACE 11MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant devices: persona trabecular metal cruciate retaining standard femoral component size 9 right, catalog #: 42502806602, lot #: 64400418, persona cemented stemmed tibial component size f right, catalog #: 42532007502, lot #: 64293488. Foreign report source: (b)(6). The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2020-01818, 0001822565-2020-01819. Investigation incomplete.

 
Event Description

It is reported that the patient underwent a right knee arthroplasty revision to address pain, potential dislocation and noise from the right knee joint one (1) week post-operatively. During the procedure, only the articular surface was removed and replaced. The dislocation could not be confirmed, however, the surgeon reported feeling a scratch when moving the implants from extension to flexion. Attempts have been made and no additional information is available at this time.

 
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Brand NamePERSONA VIVACIT-E MEDIAL CONCGRUENT ARTICULAR SURFACE 11MM
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 Key10082241
MDR Text Key191807468
Report Number0001822565-2020-01818
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK150090
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 08/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device MODEL NumberN/A
Device Catalogue Number42522100811
Device LOT Number63179254
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2015
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: 05/22/2020 Patient Sequence Number: 1
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