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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 RIGHT SIZE F PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE F PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 03/13/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 42522000510, articular surface, lot # 64295096, 42502806402, femoral component, lot # 64238042, 42540200035, patella, lot # 64021230. Report source: (b)(6).

 
Event Description

It was reported that approximately 7 months post implantation, the patient was revised due to subsidence of the tibial component. 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 RIGHT SIZE F
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 Key9886243
MDR Text Key185916049
Report Number0001822565-2020-01128
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK173417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007502
Device LOT Number64055801
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 Received04/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/21/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/26/2020 Patient Sequence Number: 1
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