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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BI-ANGULAR HUMERAL STEM; PROSTHESIS, SHOULDER
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BIOMET ORTHOPEDICS UNKNOWN BI-ANGULAR HUMERAL STEM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).
 
Event Description
Patient has been indicated for a shoulder revision due to unknown reasons.No revision has been reported to date.
 
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Brand Name
UNKNOWN BI-ANGULAR HUMERAL STEM
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6264686
MDR Text Key65312386
Report Number0001825034-2017-00228
Device Sequence Number1
Product Code MJT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/19/2017
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 Physician
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/28/2016
Initial Date FDA Received01/19/2017
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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