MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHOULDER GLENOSPHERE +6 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a reverse total shoulder arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6), 2013 due to the glenosphere disassociating from baseplate after a patient fall.The baseplate, glenosphere, humeral bearing and humeral tray were removed and replaced.Patient underwent a further revision procedure on an unknown date due to the glenosphere disassociating from the baseplate.

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 warnings, number 2 states, "disassociation of modular components have been reported.Failure to properly align and completely seat the components together can lead to disassociation." examination of returned device found no evidence of product non-conformance.Evaluation of device found evidence that failure mode was due to poor fixation of the taper adapter to the baseplate.This report is number 2 of 2 mdrs filed for the same event (reference 0001825034-2015-02732 / 02733).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent a left reverse total shoulder arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2013 due to the glenosphere disassociating from baseplate after a patient fall.The baseplate, glenosphere, humeral bearing and humeral tray were removed and replaced.Patient underwent a further revision procedure on (b)(6) 2015 due to the glenosphere disassociating from the baseplate.All components were removed and replaced with cement spacer molds.

• Brand Name: COMP RVRS SHOULDER GLENOSPHERE +6 36MM
• 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: 4869126
• MDR Text Key: 6042044
• Report Number: 0001825034-2015-02733
• 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: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 115316
• Device Lot Number: 578400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2010
• 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