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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXEL ELBOW; ELBOW, PROSTHESIS
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ZIMMER BIOMET, INC. UNKNOWN NEXEL ELBOW; ELBOW, PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
 
Event Description
It was reported that the patient underwent an elbow revision due to mechanical failure.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
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Brand Name
UNKNOWN NEXEL ELBOW
Type of Device
ELBOW, PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9688723
MDR Text Key178525564
Report Number0001822565-2020-00555
Device Sequence Number1
Product Code JDB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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