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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M PIN/BUSHING REVISION KIT, X-SMALL HUMERUS PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. C/M PIN/BUSHING REVISION KIT, X-SMALL HUMERUS PROSTHESIS, ELBOW Back to Search Results
Catalog Number 32-8105-027-01
Device Problems Fracture (1260); No Apparent Adverse Event (3189)
Patient Problem Fall (1848)
Event Date 04/17/2019
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. Not returned to manufacturer.
 
Event Description
It was reported the patient fell and the fall necessitated a revision. No further information is available at this time.
 
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Brand NameC/M PIN/BUSHING REVISION KIT, X-SMALL HUMERUS
Type of DevicePROSTHESIS, ELBOW
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 Key8537256
MDR Text Key142673298
Report Number0001822565-2019-01642
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001989
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 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number32-8105-027-01
Device Lot Number63705993
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 Received05/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2017
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: 04/22/2019 Patient Sequence Number: 1
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