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

Catalog Number 115310

Device Problem Detachment Of Device Component (1104)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is number 1 of 2 mdr's for the same patient (reference 0001825034-2017-00545/00761).Concomitant medical products: zimmer humeral stem catalog#: 00434901213 lot#63325282; zimmer poly liner catalog#: 00434903600 lot#: 63381078; biomet comprehensive screw catalog#: 180557 lot#: 350240; biomet comprehensive screw catalog#: 180550 lot#: 331050; biomet comprehensive screw catalog#180552 lot#: 070920; comprehensive screw catalog#: 180551 lot#: 445140.

Event Description

It is reported that the patient underwent a shoulder arthroplasty revision 17 days post-implantation due to disassociation of the glenosphere, caused by infection.The glenosphere and central screw were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, this component is determined to be not reportable as this was disassociation, and this malfunction solely involves the taper from the baseplate.The initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
• 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: 6342349
• MDR Text Key: 67802916
• Report Number: 0001825034-2017-00545
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 115310
• Device Lot Number: 365980
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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
• Patient Age: 75 YR