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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a shoulder arthroplasty on an unknown date in 1997.Subsequently, a revision procedure has been indicated due to dislocation superiorly; however, no revision has been reported to date.

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 as the limited information available indicates that a revision may occur.Should additional information be received, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Manufacturer Narrative

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

Event Description

It was reported that patient underwent a shoulder arthroplasty on an unknown date in 1997.Subsequently, a revision occurred on (b)(6) 2015 due to dislocation superiorly.The proximal body was removed and replaced.

• Brand Name: UNKNOWN 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: 4572114
• MDR Text Key: 17690378
• Report Number: 0001825034-2015-00807
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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: 04/02/2015

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2015
• 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