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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED COATED ELBOW HUMERUS PROSTHESIS

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ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED COATED ELBOW HUMERUS PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Fracture, Arm (2351)
Event Date 07/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Remains implanted.
 
Event Description
It was reported the patient was noted to have a previous insufficiency fracture of the columns. Product remains implanted with no reported intervention at this time. No further information has been made available at the time of this reporting.
 
Manufacturer Narrative
No device was returned. Medical records were reviewed and it was determined pt had known rheumatoid arthritis with ulnar neuropathy. X-ray evaluation confirms the reported patient bone fracture in-vivo. Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified. Root cause is unknown. 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
No further information has been made available at the time of this reporting.
 
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Brand NameHUMERAL COMPONENT PLASMA SPRAYED
Type of DeviceCOATED ELBOW HUMERUS PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8979759
MDR Text Key157070558
Report Number0001822565-2019-03834
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00840004415
Device Lot Number63250330
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/10/2019 Patient Sequence Number: 1
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