MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISC ULNA 3X115MM RT W/BRNG C; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported a patient underwent a tight total elbow arthroplasty on (b)(6) 2013.Subsequently the patient was revised on the following dates for unknown reasons (b)(6) 2014, and (b)(6) 2014.Currently, the patient will be having an upcoming revision for loosening of the ulna component and pmi will be making a custom implant for this procedure.A date for this revision has not been scheduled.

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: "loosening, migration, and/or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity." this report is number 3 of 3 mdr's filed for the same event (reference 1825034-2015-02179 and 02180 and 02181).

• Brand Name: DISC ULNA 3X115MM RT 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: 4796072
• MDR Text Key: 5830750
• Report Number: 0001825034-2015-02181
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 114817
• Device Lot Number: 371330
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2010
• 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