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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 11/28/2014

Event Type  Injury  

Event Description

It was reported patient underwent a comprehensive reverse total shoulder arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to the morse taper disassociating from the baseplate.The morse taper was reimplanted and the humeral bearing was removed and replaced.A further revision procedure has been indicated due to the disassociation of the morse taper from the baseplate; however, no revision procedure has been reported to date.

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 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity.'.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Event Description

It was reported patient underwent a comprehensive reverse total shoulder arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to the morse taper disassociating from the baseplate.The morse taper was reimplanted and the humeral bearing was removed and replaced.The patient was revised again on (b)(6) 2014 due to disassociation of the morse taper from the baseplate.

Manufacturer Narrative

Dimensional evaluation of the returned device found that all features were within design specifications and the product performed as intended.There are warnings in the package insert that state that this type of event can occur and disassociation of modular components have been reported.Failure to properly align and completely seat the components together can lead to disassociation.Interference from patient¿s bone or improper placement of the central screw are also factors which could contribute to the disassociation.

• 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: 4322150
• MDR Text Key: 5243426
• Report Number: 0001825034-2014-09000
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• 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,Followup
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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: 780090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2014
• 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: 77 YR