MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS CNTRL SCREW 6.5X30MM ST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 11/03/2014

Event Type  Injury  

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: "intraoperative or postoperative bone fracture and/or postoperative pain." "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".

Event Description

Legal counsel for patient reported that patient underwent total reverse shoulder arthroplasty and a subsequent revision procedure on (b)(6) 2014 due to patient allegations of pain and fractured screw.Patient's legal counsel further reported that a portion of the fractured screw allegedly remains in the patient.A review of invoice history revealed that the initial procedure took place on (b)(6) 2012 and confirmed the revision surgery date.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information provided in patient medical records indicates that the revision procedure was performed due to glenoid loosening as a result of a fractured central screw in the baseplate.Medical records further indicate that all components except the humeral stem were removed and replaced.There is no indication in the revision operative report that any portion of the fractured screw was left in the patient.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 9 mdr's filed for the same event (reference 1825034-2015-01365-2 / 2015-00568 / 2015-00571 / 2015-00572 / 2015-00573 / 2015-00574 / 2015-00575 / 2015-00576 / 2015-00577).Not returned by attorney.

Event Description

Legal counsel for patient reported that patient underwent total reverse shoulder arthroplasty and a subsequent revision procedure on (b)(6) 2014 due to patient allegations of pain and fractured screw.Patient's legal counsel further reported that a portion of the fractured screw allegedly remains in the patient.A review of invoice history revealed that the initial procedure took place on (b)(6) 2012 and confirmed the revision surgery date.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information provided in patient medical records indicates that the revision procedure was performed due to glenoid loosening as a result of a fractured central screw in the baseplate.Medical records further indicate that all components except the humeral stem were removed and replaced.There is no indication in the revision operative report that any portion of the fractured screw was left in the patient.Additional information received from patient's legal counsel reported that on (b)(6) 2014, patient experienced gradual onset of pain reported and x-ray indicated that the central screw had fractured and the baseplate had shifted.It was further reported that on (b)(6) 2015, patient underwent an aspiration procedure due to irritated swollen area.On (b)(6) 2015, the surgical site burst open and wept a discolored fluid during therapy session.Subsequently, patient underwent an irrigation and debridement procedure on (b)(6) 2015.A culture taken confirmed bacterial infection.Patient was revised again on (b)(6) 2015 due to deep infection.During the procedure, the patients shoulder was fused with cement spacers.On (b)(6) 2015 patient was taken to the hospital for an allergic reaction to the coating on the spacers.

• Brand Name: COMP RVS CNTRL SCREW 6.5X30MM ST
• 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: 4665627
• MDR Text Key: 19068731
• Report Number: 0001825034-2015-01365
• 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: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 115382
• Device Lot Number: 628380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2012
• 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; Disability
• Patient Age: 69 YR