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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE H PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE H 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 11/16/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00321, 0001822565-2020-04057. Concomitant medical products: femur cemented posterior stabilized (ps) standard right size 8 catalog#: 42500606402, lot#: 62779777, articular surface fixed bearing ps right 10 mm height catalog#: 42522400910, lot#: 62351259. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the patient underwent a right knee revision approximately six years¿ post-implantation due to pain, stiffness, and loosening. During the revision, osteolysis was noted under the femoral. Attempts to obtain additional information have been made; however, no more is available.

 
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Brand NameNATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE H
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 Key10985072
MDR Text Key220716477
Report Number0001822565-2020-04058
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530008302
Device LOT Number62648727
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/25/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/08/2014
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: 12/10/2020 Patient Sequence Number: 1
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