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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN ULNAR COMPONENT PROSTHESIS, ELBOW

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BIOMET ORTHOPEDICS UNKNOWN ULNAR COMPONENT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 01/19/2010
Event Type  Injury  
Manufacturer Narrative
This report is being submitted to relay corrected information. Upon reassessment of the reported event, it was determined to be not reportable as this event is attributable to patient condition, and no problem is alleged with the device.
 
Manufacturer Narrative
(b)(6). Concomitant medical products: unknown humeral component; unknown condyle. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 05885 , 0001825034 - 2017 - 05886. The device will not be returned for analysis, as it remains implanted; however, an investigation has been initiated. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that patient underwent a tendon rupture repair 11 years post-implantation. Operative report indicates no implant failure. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN ULNAR COMPONENT
Type of DevicePROSTHESIS, ELBOW
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 Key6768755
MDR Text Key120463957
Report Number0001825034-2017-05884
Device Sequence Number1
Product Code JDC
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
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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?
Event Location No Information
Date Manufacturer Received01/09/2018
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: 08/04/2017 Patient Sequence Number: 1
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