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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 05/22/2014

Event Type  Injury  

Event Description

It was reported patient underwent left elbow arthroplasty on an unknown date.Subsequently, patient underwent a revision procedure on (b)(6) 2010 due to unknown reasons and a revision procedure on (b)(6) 2014 due to polyethylene wear and disassociation of the locking pin from the bearing.

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.Product is being returned to manufacturer, but has not yet been received.Upon completion of evaluation, a follow up report will be sent to the fda.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states,"wear and/or deformation of articulating surfaces." under warnings it states, "properly align and completely seat connecting components including tapers.Failure to properly align and completely seat the components together can lead to disassociation." and "malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.".

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was determined that the lock pin and bearing disassociated from the ulna stem which resulted in damage to the lock pin, bearing, and condyles.

• Brand Name: DISCOVERY ULNA BEARING REVISION 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: 3879523
• MDR Text Key: 16684671
• Report Number: 0001825034-2014-05598
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 114800
• Device Lot Number: 891630
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2007
• 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