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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M HUMERAL ELBOW STEM PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. C/M HUMERAL ELBOW STEM PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Reaction (2414)
Event Date 05/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign country: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been reported that patient was revised after unknown duration of initial surgery due to fracture of the humeral stem, loosening, metallosis and pain. No additional patient consequences were reported.
 
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Brand NameC/M HUMERAL ELBOW STEM
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 Key8664814
MDR Text Key146891591
Report Number0001822565-2019-02295
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32810502606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated by Manufacturer? Yes
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: 06/03/2019 Patient Sequence Number: 1
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