MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN COMPREHENSIVE REVERSE SHOULDER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.Discarded.

Event Description

It was reported that the patient underwent a total shoulder arthroplasty on (b)(6) 2016.Subsequently, the patient was revised on (b)(6) 2016 due to dislocation and impingement.During the procedure, the glenosphere and taper adapter were removed and replaced.

Manufacturer Narrative

This follow up report is being filed to relay corrected information.

Event Description

Patient was revised 14 days post-implantation due to impingement and disassociation of the glenosphere from the baseplate.During the procedure, the glenosphere and taper adapter were removed and replaced.

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE SHOULDER
• 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: 5609623
• MDR Text Key: 43716635
• Report Number: 0001825034-2016-01381
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• 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: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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