MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE UNCEMENTED 15 MM POST LENGTH; PROSTHESIS, SHOULDER

Catalog Number 00436201500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product code: phx.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during total reverse shoulder while impacting the base plate the patient's glenoid fractured.Surgeon converted to hemi arthroplasty.Surgeon believes it was a combination of a small anatomy, poor bone quality and inadequate visualization due the instrument (due to the size).Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: tm rvs base plate inserter cat# 00-4361-044-00 lot# 64450198.

Event Description

No further event information available at the time of this report.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10.No product was returned; visual and dimensional evaluations could not be performed.A picture of the inserter was provided and device info was etched on it.No other evaluation can be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.There is a design enhancement on the inserter which now manufactures 2 wings from the initial 4 wings to avoid a potential interference condition with retractors in the anterior or posterior side with the tight joint space.However, a definitive root cause could not be determined.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: BASE PLATE UNCEMENTED 15 MM POST LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9519388
• MDR Text Key: 172705966
• Report Number: 0001822565-2019-05418
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K172767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00436201500
• Device Lot Number: 64390369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 03/23/2020; 06/10/2020
• Supplement Dates FDA Received: 03/31/2020; 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention