MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ACROM XL 44-41 STD +3; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 03/03/2016

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 the 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 7 states, "inadequate range of motion due to improper selection or positioning of components, lack of rotator cuff, and inadequate function of the deltoid." number 12 states, "wear and/or deformation of articulating surfaces." number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 2 of 4 mdrs filed for the same patient (reference 1825034-2016-03952/ 03978 / 03979 and 1825034-2013-01519).

Event Description

Patient alleges that he underwent a left shoulder revision due to pain, decreased range of motion, and incorrect selection of implant size approximately three years post-implantation.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Operative reports noted that the patient had adhesions and scar tissue present between the deltoid and proximal humerus, soft tissue noted around the humeral stem, impingement, and erosions on the bearing.The humeral bearing, tray, glenosphere, and taper adaptor were removed and replaced.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ACROM XL 44-41 STD +3
• 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: 6002768
• MDR Text Key: 56591739
• Report Number: 0001825034-2016-03952
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: XL-115367
• Device Lot Number: 968430
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2012
• 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
• Patient Age: 72 YR