MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISC ULNA 4X115MM LT W/BRNG C; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/13/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent left total elbow arthroplasty on (b)(6) 2009.Subsequently, patient underwent revision procedures on (b)(6) 2011 and (b)(6) 2012 due to bone fractures caused by patient's poor bone quality.A custom component has been requested for this patient and an upcoming revision procedure has been indicated due to a fractured ulna component.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.There are warnings in the package insert that state that this type of event can occur: ¿fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

Manufacturer Narrative

This follow-up is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient underwent left total elbow arthroplasty on (b)(6) 2009.Subsequently, patient underwent revision procedures on (b)(6) 2011 and (b)(6) 2012 due to bone fractures caused by patient's poor bone quality.A revision procedure was performed on (b)(6) 2014 to replace the ulna component with a custom component as the ulna component had fractured.

• Brand Name: DISC ULNA 4X115MM LT W/BRNG C
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4248571
• MDR Text Key: 5106706
• Report Number: 0001825034-2014-08523
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 114826
• Device Lot Number: 674000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention