MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISC ULNA BEARING KIT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 01/20/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a left total elbow arthroplasty on an unknown date.Subsequently, a revision procedure was performed on (b)(6) 2009 to remove and replace the ulna bearing due to an unknown reason.It is further reported that a revision procedure is planned due to loose bone on the distal humerus; however, there has been no revision procedure reported to date.

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 anomaly or deviation.

Manufacturer Narrative

This component is not related to the event.This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity.¿ this report is number 1 of 3 mdr's filed for the same event (reference 1825034-2014- 09137 and 1825034-2015- 00337 / 00338).

Event Description

It was reported that patient underwent a left total elbow arthroplasty on (b)(6) 2005.Subsequently, a revision procedure was performed on (b)(6) 2009 due to an unknown reason.The ulna bearing was removed and replaced.Patient underwent a further revision procedure on (b)(6) 2015 due to loosening of the humeral component possibly from bone loss.The humeral component was removed and replaced.

• Brand Name: DISC ULNA BEARING KIT
• 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: 4330924
• MDR Text Key: 21237831
• Report Number: 0001825034-2014-09137
• 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: 01/09/2015

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: 10/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 114800
• Device Lot Number: 638980
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2006
• 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