MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISC CONDYLE KIT W/ HEXALOBULA; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Fracture (1260); Device Slipped (1584); Material Integrity Problem (2978)

Patient Problems Non-union Bone Fracture (2369); Chemical Exposure (2570); Test Result (2695)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It was reported patient underwent a right total elbow arthroplasty in 2005.Subsequently, the patient was revised in 2008 due to a periprosthetic fracture caused by a crash.Plates and wire were implanted.Patient underwent a further revision procedure in (b)(6) 2009 due to non-union of the fracture.Review of radiographs on (b)(6) 2014 revealed a loose or fractured ulna poly.Subsequently, patient was further revised on (b)(6) 2014.During the procedure, metallosis was noted.The ulna component and distal humerus component were removed and replaced.

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions and particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant." this report is number 3 of 3 mdrs filed for the same event (reference 1825034-2015- 00022 / 00024).

Manufacturer Narrative

Evaluation of the returned component found abrasions.Product likely failed due to patient¿s excessive activity and/or lifting unacceptable weight repeatedly.No dimensional inspection was performed due to excessive wear and damage to the component.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.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.

• Brand Name: DISC CONDYLE KIT W/ HEXALOBULA
• 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: 4384054
• MDR Text Key: 5369551
• Report Number: 0001825034-2015-00024
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 114700
• Device Lot Number: 084750
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2009
• 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
• Patient Age: 75 YR