MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP PRIMARY STEM 7MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804)

Patient Problem Toxicity (2333)

Event Date 05/16/2014

Event Type  Injury  

Event Description

It was reported patient underwent a right comprehensive reverse total shoulder arthroplasty on (b)(6) 2010.Subsequently patient was revised on (b)(6) 2014 due to the post fracturing from the humeral tray on the humeral stem.Post operative report noted loose metal and metallosis during the revision procedure.The humeral bearing, humeral tray and humeral stem were removed and replaced.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

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: under possible adverse effects, number 1 states, " material sensitivity reactions." number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." this report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-06829 & 06836).

• Brand Name: COMP PRIMARY STEM 7MM MINI
• 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: 3981657
• MDR Text Key: 4637859
• Report Number: 0001825034-2014-06829
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 113627
• Device Lot Number: 878240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2010
• 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
• Patient Age: 67 YR