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

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/19/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a shoulder revision procedure on (b)(6) 2013 where a reverse shoulder was implanted.Subsequently, patient was revised on (b)(6) 2015 due to fracture of the humeral tray.Additional information provided indicates the fracture occurred while the patient was swimming.During the revision procedure, the male taper of the tray was stuck in the female end of the stem and a delay of 40 minutes occurred due to multiple attempts to remove the taper from the stem.The humeral tray, bearing and stem were 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 that this type of event can occur: "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, it was noted the root cause of the event was most likely due to biomechanical overload.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL TI 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: 4606591
• MDR Text Key: 21451414
• Report Number: 0001825034-2015-01019
• 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,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 282230
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2013
• 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