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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN NEXEL ULNAR COMPONENT PROSTHESIS, ELBOW

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ZIMMER, INC. UNKNOWN NEXEL ULNAR COMPONENT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(6). The complaint sample was unable to be evaluated and the reported event was not confirmed. The device history records review was unable to be performed as the lot number of the device involved in the event is unknown. A review of the complaint history was unable to be performed as the part and lot number are unknown. The most likely root cause of the reported issue could not be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It is reported that the patient is scheduled to undergo elbow arthroplasty revision to implant a longer ulnar component due to unknown reasons. No additional patient consequences have been reported and no revision procedure has been reported to date.
 
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Brand NameUNKNOWN NEXEL ULNAR COMPONENT
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6564517
MDR Text Key75061317
Report Number0001822565-2017-03245
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/12/2017 Patient Sequence Number: 1
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