MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHESIVE REVERSE HUMERAL TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 07/25/2014

Event Type  Injury  

Event Description

It was reported that patient underwent total shoulder arthroplasty on (b)(6) 2011.Subsequently, the patient was revised on (b)(6) 2014, due to fracturing of the taper on the humeral tray.During the revision procedure, the taper would not detach from the humeral stem, therefore the humeral stem had to be removed and replaced.The humeral tray and humeral bearing were also removed and replaced.

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 this type of event can occur: possible adverse effects states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

• Brand Name: COMPREHESIVE REVERSE HUMERAL TRAY 44MM
• Type of Device: PROSTHESIS, SHOULDER
• 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: 4021169
• MDR Text Key: 4843475
• Report Number: 0001825034-2014-07118
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• 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: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 558910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2010
• 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