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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL COMPONENT; PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN HUMERAL COMPONENT; PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an elbow arthroplasty on an unknown date.The patient is being considered for a revision on an unknown day for an unknown reason.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).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 (dhr) 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
UNKNOWN HUMERAL COMPONENT
Type of Device
PROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key12331844
MDR Text Key266906075
Report Number0001822565-2021-02296
Device Sequence Number1
Product Code JDB
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/26/2021
Initial Date FDA Received08/17/2021
Supplement Dates Manufacturer Received09/01/2021
Supplement Dates FDA Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNK ULNA COMPONENT UNK.; UNK ULNA COMPONENT UNK
Patient Outcome(s) Other;
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