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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMET REGENX PRI TIB TRAY 79MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BMET REGENX PRI TIB TRAY 79MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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 had an initial right knee arthroplasty on unknown date. Subsequently, the patient is being considered for a revision on unknown date due to unknown reasons. There is no additional information at this time.

 
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Brand NameBMET REGENX PRI TIB TRAY 79MM
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 Key8455271
MDR Text Key139968245
Report Number0001825034-2019-01446
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number141275
Device LOT Number158670
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 Received09/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2013
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: 03/27/2019 Patient Sequence Number: 1
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