MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STANDARD 41MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/26/2016

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 the lot released with no recorded anomaly or deviation.(b)(4).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.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions.".

Event Description

Patient underwent a shoulder revision approximately 21 days post-implantation due to dislocation.Glenosphere and taper adapter were removed and replaced.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STANDARD 41MM
• 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: 6055423
• MDR Text Key: 58353441
• Report Number: 0001825034-2016-04254
• 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
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115320
• Device Lot Number: 990570
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• 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