MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 08/10/2015

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.No dimensional analysis was performed.Root cause was identified by the sales representative.Excessive bone has been implicated as a cause for taper connections to not engage which leads to disassociation.Further instructions in the surgical technique call for inspection and testing of the taper connections before closure.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity.¿ number 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning." "note: it is critical to use the included glenoid planar to remove excess bone and soft tissue that may prevent complete impaction of the glenosphere/taper assembly into the baseplate." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03931 / 03932).

Event Description

It was reported that the patient underwent right reverse total shoulder arthroplasty on (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to the glenosphere disassociating from the base plate.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• 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: 5090575
• MDR Text Key: 26265945
• Report Number: 0001825034-2015-03931
• Device Sequence Number: 1
• Product Code: MBF
• 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
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 079030
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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