MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER

Catalog Number 118001

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.(b)(4).Medical product -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 3 of 4 mdrs 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 SHOULDER SYSTEM STANDARD TAPER ADAPTOR
• 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: 6352484
• MDR Text Key: 68111768
• Report Number: 0001825034-2017-00874
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• 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 Catalogue Number: 118001
• Device Lot Number: 374280
• Other Device ID Number: REFERENCE H10
• 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: 06/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: REFERENCE H10
• Patient Outcome(s): Hospitalization; Required Intervention