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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK BUSHING; PROSTHESIS, ELBOW
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ZIMMER BIOMET, INC. UNK BUSHING; PROSTHESIS, ELBOW Back to Search Results
Device Problem Naturally Worn (2988)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
In a journal article published approximately 1 year ago, studying tea failure rates, it was reported that 3 of 46 patients underwent a revision due to bushing wear.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information is available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h6, h10.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
UNK BUSHING
Type of Device
PROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10104769
MDR Text Key194621022
Report Number0001822565-2020-01933
Device Sequence Number1
Product Code KWI
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,study
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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