MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP NON-LCKNG SCREW 4.75X35MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Unspecified Infection (1930)

Event Date 01/22/2015

Event Type  Injury  

Event Description

It was reported patient underwent a comprehensive reverse total shoulder arthroplasty on (b)(6) 2012.Subsequently, patient was revised on (b)(6) 2015 due to a fractured screw caused by a malpositioned baseplate and stem.During the procedure, infection was noted.All components were removed and cement spacer molds were implanted.The fractured screw remains in the patient.There was a reported delay of 40-45 minutes due to the stem being well fixed and difficult to explant.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under warnings it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." and " fatigue fracture of component may occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." and "early or late postoperative infection and allergic reaction.".

• Brand Name: COMP NON-LCKNG SCREW 4.75X35MM
• 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: 4476839
• MDR Text Key: 5401420
• Report Number: 0001825034-2015-00431
• 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: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• 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: 180511
• Device Lot Number: 468690
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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: 57 YR