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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 Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: articular surface medial congruent (mc) left 10 mm height use with tibia sizes g-h/cr femur size 12 catalog#: 42512101010, lot#: 63179244. Femur trabecular metal cruciate retaining (cr) standard porous, catalog#: 42502807401, lot#: 64116364. 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 left total knee arthroplasty. Subsequently, approximately thirteen (13) months later, the patient was revised due to subsidence. No additional information is available at this time.

 
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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 Key9774208
MDR Text Key189465885
Report Number0001822565-2020-00758
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173417
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 06/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007901
Device LOT Number63927610
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/04/2018
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: 03/02/2020 Patient Sequence Number: 1
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