MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIO-MOD ST. 9X115 HUMERAL STEM W/ALIGN HOLE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/14/2014

Event Type  Injury  

Event Description

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

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: "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resumption, excessive activity." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-06873 and 07556).

Event Description

It was reported that patient underwent total shoulder arthroplasty on (b)(6) 2002.Subsequently, a revision procedure was performed on (b)(6) 2014 due to humeral stem loosening and glenoid component spin out.All components were removed and replaced with a reverse shoulder system.

• Brand Name: BIO-MOD ST. 9X115 HUMERAL STEM W/ALIGN HOLE
• 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: 3985223
• MDR Text Key: 4887407
• Report Number: 0001825034-2014-06873
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030710
• 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: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 11-113705
• Device Lot Number: 603430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2001
• 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): Required Intervention
• Patient Age: 73 YR