MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHLDR GLNSP STD 41MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 01/16/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a total shoulder arthroplasty on (b)(6) 2013.Review of invoice history indicates a revision procedure was performed on (b)(6) 2014 due to an unknown reason.Subsequently, the patient was revised on (b)(6) 2015 due to dislocation.The humeral bearing and glenosphere were removed and replaced.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-00372 / 00373).

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 the patient underwent a total shoulder arthroplasty on (b)(6) 2013.Review of invoice history indicates a revision procedure was performed on (b)(6) 2014 due to an unknown reason.Subsequently, the patient was revised on (b)(6) 2015 due to dislocation as a result of patient non-compliance.The humeral bearing and glenosphere were removed and replaced.

• Brand Name: COMP RVRS SHLDR GLNSP STD 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: 4459972
• MDR Text Key: 18037433
• Report Number: 0001825034-2015-00373
• 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,Followup
• Report Date: 03/24/2015

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: 115320
• Device Lot Number: 213360
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2014
• 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