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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Pain (1994)
Event Date 07/06/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 42511200611 - articular surface fixed bearing ¿ 62638121; 42502807001 - femur trabecular metal cruciate ¿ 62650398. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it the product location is unknown. 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 knee revision approximately 30 months post implantation due to pain and tibial loosening. Attempts have been made, and no further information has been provided.

 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G
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 Key8663967
MDR Text Key146840340
Report Number0001822565-2019-02286
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 CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007901
Device LOT Number62374749
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 Received10/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/24/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1266-2015

Patient TREATMENT DATA
Date Received: 06/03/2019 Patient Sequence Number: 1
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