MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

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.Date implanted - (b)(6) 2016.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning.".

Event Description

Patient underwent a shoulder revision procedure approximately two weeks post-implantation due to dislocation of the glenosphere.The glenosphere and taper adaptor were removed and replaced.During the revision it was noted the screw for the baseplate could be rotated and a bone spur was removed.

Manufacturer Narrative

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

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as this component did not cause the event.The initial report should be voided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 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: 5965911
• MDR Text Key: 55207898
• Report Number: 0001825034-2016-03703
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 115310
• Device Lot Number: 349400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/19/2016; 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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