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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 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Scar Tissue (2060)
Event Date 09/18/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Associated products : item#: 00587806535; articular surface medial congruent (mc) right 10 mm ;lot#: 62539460. Item#: 42502806401; femur trabecular metal cruciate retaining (cr) standard porous; lot#: 62388855. Item#: 42511000516; all poly patella cemented 35 mm diameter; lot#:62461382. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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 an initial left knee arthroplasty and subsequently 4. 5 years later due to tibial loosening and scar tissue.

 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT
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 Key10356436
MDR Text Key201524715
Report Number0001822565-2020-02769
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007501
Device LOT Number62365104
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2013
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: 08/03/2020 Patient Sequence Number: 1
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