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

Model Number N/A

Device Problems Off-Label Use (1494); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical products: biomet comprehensive shoulder system humeral fracture stem catalog #:12-113562, lot#:012980; biomet comprehensive reverse shoulder glenosphere baseplate catalog#:115330, lot#: 507240; comprehensive central screw catalog#115395, lot#: 366030; comprehensive lock screw catalog#: 180550, lot#: 429450; comprehensive lock screw catalog#: 180551, lot#:452420; comprehensive lock screw catalog#:180554, lot#:028240; comprehensive lock screw catalog#:180555, lot#:452560; cobalt bone cement catalog#:402439, lot#:472300; cobalt bone cement catalog#:402439, lot#:937030; cable sleeve catalog#:120005, lot#:448190, troch cable catalog#:120002, lot#:386410; cable sleeve catalog#:120005, lot#:448190, troch cable catalog#:120002, lot#:607700; cable sleeve catalog#:120005, lot#:515810.This report is number 2 of 4 mdr's filed for the same patient (reference 1825034-2016-04210/ 0001825034-2017-00871/ 0001825034-2017-00874/ 0001825034-2017-00875).

Event Description

Legal counsel for the patient reported that the patient experienced implant failure 27 days post-operatively, as the patient¿s implanted right shoulder was noted to have dropped lower than the patient¿s left shoulder.Subsequently, the patient underwent a right shoulder revision procedure 29 days post-implantation due to the alleged failed shoulder implant and allegations of increased pain.It is further alleged that the device was contra-indicated and inadequate for the patient¿s condition and that the device was malpositioned.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 TRAY
• 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: 6352474
• MDR Text Key: 68110372
• Report Number: 0001825034-2017-00871
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 115378
• Device Lot Number: 570660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention