MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/25/2017

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.In the package insert under possible adverse effects, item 10 states: fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.Medical product - comp primary stem 16mm std catalog #: 113656 lot #: 110350, comp locking screw catalog #: 180501 lot #: 710430, comp non-lckng screw catalog #: 180509 lot #: 999860, comp rvrs shdr glen bsplt catalog #: 115330 lot #: 628500, comp non-lckng screw catalog #: 180508 lot #: 979470, comp rvs cntrl scr catalog #: 115381 lot #: 345270, std hmrl brng catalog #: xl-115366 lot #: 340340, versa dial/comprehensive std t pr adaptor catalog #: 118001 lot #: 182190, comprehensive reverse shoulder glenosphere catalog #: 115326 lot #: 484540 this is 1 of 5 reports being filed for the same patient (reference 1825034-2017-00721 - 00725).

Event Description

It is reported that the patient was revised due to implant fracture approximately 4 years post-implantation.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
• 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: 6340558
• MDR Text Key: 67718319
• Report Number: 0001825034-2017-00721
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 157340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2012
• 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
• Treatment: SEE H10 SUMMARY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR