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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Pain (1994)
Event Date 05/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant devices: articular surface medial congruent (mc) left 10 mm height use with tibia sizes e-f/cr femur sizes 8-11, catalog #:42512100810, lot #: 64463461; femur trabecular metal cruciate retaining (cr) standard porous, catalog #: 42502806401, lot #:63417244; psn tm fem/tmtib/ve/tm/ins, catalog #: 98-0002-001-18, lot #: n/i. The complainant has indicated that the product will not be returned to zimmer biomet for investigation. Hospital did not return. Once the investigation has been completed, a follow-up mdr will be submitted. Investigation incomplete.
 
Event Description
It was reported the patient underwent a left knee arthroplasty on an unknown date. Subsequently, was revised due to pain in his tibia. It was determined that the tm tibia was loose. Revised to standard cemented components.
 
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Brand NamePERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E
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 Key11947953
MDR Text Key254620408
Report Number0001822565-2021-01561
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42530007101
Device Lot Number64405777
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 Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
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: 06/07/2021 Patient Sequence Number: 1
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