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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6 PROSTHESIS, EXTREMITY

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ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6 PROSTHESIS, EXTREMITY Back to Search Results
Catalog Number 00840009500
Device Problem No Apparent Adverse Event (3189)
Patient Problems Reaction (2414); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device evaluated by mfr: device remains implanted.
 
Event Description
It was reported the patient suffered a fractured ulna as a result of a patient fall not related to any zimmer biomet device. Upon presenting for medical care, it was identified the patient had a metal allergy and a custom prosthesis has been requested. No device is available as the patient has not yet been revised.
 
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Brand NameARTICULATION KIT SIZE 5/6
Type of DevicePROSTHESIS, EXTREMITY
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 Key8524096
MDR Text Key142254603
Report Number0001822565-2019-01547
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123862
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 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840009500
Device Lot Number63618395
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 Received06/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2017
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: 04/17/2019 Patient Sequence Number: 1
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