MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISC ULNA 5X75MM LT W/BRNG C; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem Fracture, Arm (2351)

Event Date 02/17/2014

Event Type  Injury  

Event Description

It was reported patient underwent total elbow arthroplasty on (b)(6) 2005.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to a loose and possibly fractured ulna bearing.The ulna bearing and condoyle were removed and replaced.

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 or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, "loosening, migration, and/or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity." number 11 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

• Brand Name: DISC ULNA 5X75MM LT W/BRNG C
• Type of Device: PROSTHESIS, 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4018008
• MDR Text Key: 17614888
• Report Number: 0001825034-2014-07145
• 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
• Report Date: 07/25/2014

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 Expiration Date: 06/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 114832
• Device Lot Number: 326850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2004
• 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): Hospitalization; Required Intervention