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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11575036
• Report Number: 0001822565-2021-00865
• Device Sequence Number: 4206088
• Product Code: PAO
• UDI-Device Identifier: 00887868231322
• UDI-Public: (01)00887868231322(17)300228(10)64691513
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention