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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN HUMERAL STEM PROSTHESIS ELBOW Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Fracture, Arm (2351); Osteopenia/ Osteoporosis (2651)
Event Type  Injury  
Manufacturer Narrative
(b)(4). (udi): n/a. Reported event was unable to be confirmed due to limited information received from the customer. However per the x-ray review it can be seen that the patient had hardware failure including fracture and loosening of the distal humeral as well as bony fragments within the joint space and osteopenia. There was also a possibility of proximal humeral diaphysis. 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 remains implanted.
 
Event Description
It was reported that a patient underwent a right elbow arthroplasty on an unknown date. Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason. The sales rep was inquiring about implant identification and stated they had no further information. The x-ray provided shows bone fractures and loosening of the device. No additional information is available.
 
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Brand NameUNKNOWN HUMERAL STEM
Type of DevicePROSTHESIS ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9765073
MDR Text Key191733306
Report Number0001822565-2020-00734
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2020
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: 02/27/2020 Patient Sequence Number: 1
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