MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 09/17/2013

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 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.¿ medical product - comprehensive locking screw catalog #: 180502 lot #:388400, comprehensive locking screw catalog #: 180500 lot #: 828340, comprehensive reverse central screw catalog #: 115383 lot #: 843190, comprehensive reverse shoulder 9 in steinmann catalog #: 405800 lot #: 904720, comprehensive primary stem 10 mm mini catalog #: 113630 lot #: 114710, comprehensive reverse shoulder glenosphere std 36 mm catalog #: 115310 lot #: 603120, comprehensive reverse fixed locking screw catalog #: 180500 lot #: 172380, comprehensive reverse tray co 44 mm catalog #: 115370 lot #: 460110, comprehensive non-locking screw catalog #: 180507 lot #: 258080, comprehensive reverse central screw catalog #: 115382 lot #: 602710.This is 1 of 2 reports being filed for the same patient (reference 1825034-2017-00114 / 00115).This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Event Description

Patient's legal counsel reported that patient was revised approximately 31 days post-implantation due to alleged failure of device.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6241023
• MDR Text Key: 64494063
• Report Number: 0001825034-2017-00114
• 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: Attorney
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 202280
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• 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