MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI HUMERAL TRAY +5 MM THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: item number: 110031422, item name: humeral bearing, lot number: 64361197; item number: 110030777, item name: versa-dial glenosphere, lot number: 64416224.Reported event was confirmed per the x-rays and visual assessment which stated disassociated humeral poly from humeral tray found.The returned tray and bearing showed damage.The glenosphere was not returned.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision was 2-month status post left total reverse shoulder noted 'did well till suffered an injury and dislocated prosthesis.' disassociated humeral poly from humeral tray found.Replaced tray and poly found stable and good rom.No complications.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04043, 0001825034 - 2020 - 04044.The information provided on this form was previously submitted under manufacturing report number 0001825034-2020-04042.

Event Description

It was reported patient underwent a left shoulder revision surgery approximately two months post-implantation due to dislocation.During surgery it was discovered that the poly insert was free floating, and no longer attached to the tray.The tray and liner components were removed and replaced.Attempts have been made and no additional information is available at this time.

• Brand Name: MINI HUMERAL TRAY +5 MM THICKNESS +0 MM TAPER OFFSET 40 MM DIAMETER
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11575036
• MDR Text Key: 242427756
• Report Number: 0001822565-2021-00865
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00887868231322
• UDI-Public: (01)00887868231322(17)300228(10)64691513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031400
• Device Lot Number: 64691513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention