MAUDE Adverse Event Report: BIOMET SET E1 44-36 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 09/10/2015

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 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: 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.¿ this report is number 2 of 2 mdrs filed for the same event (reference 0001825034-2015-04094 / 04095).

Event Description

It was reported that the patient underwent an initial left total reverse shoulder arthroplasty on (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to dislocation.The dislocation was due to lengthening of the deltoid and soft tissue tension.The surgeon revised the stem, tray, bearing, and glenosphere.

• Brand Name: E1 44-36 STD +3 HMRL BRG
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET SET; 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: 5110165
• MDR Text Key: 26984145
• Report Number: 0001825034-2015-04095
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/10/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-115394
• Device Lot Number: 492430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• 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