MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN DISCOVERY ELBOW; PROSTHESIS, ELBOW

Model Number N/A

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial right elbow procedure on an unknown date in 2005.The patient was involved in a crash and had a periprothesis fracture in the right elbow on an unknown date in 2008.The fracture was treated by plating and wiring.Subsequently, the patient underwent a revision procedure on an unknown date in (b)(6) 2009 due to right elbow fracture non-union.The distal humerus components were revised.Radiographs taken on (b)(6) 2014 revealed that the ulna polyethylene component appears to be fractured or loose.A revision has been indicated; however, no revision procedure has been reported to date.

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)(6).

• Brand Name: UNKNOWN DISCOVERY ELBOW
• 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: 4358139
• MDR Text Key: 5234405
• Report Number: 0001825034-2014-09268
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention