MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE VERSA-DIAL REVERSE SHOULDER SYSTEM GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110030776
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Impingement (4834)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 110047346; lot#: 66386232, item#: 110027734; lot#: 67177131, item#: 115397; lot#: 66940936, item#: 180556; lot#: 652080, item#: 180555; lot#: 66963221, item#: 180554; lot#: 67004729, item#: 180552; lot#: 67121448, item#: sahs1112; lot#: 66775291, item#: sahtnem6; lot#: 67162853.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a revision approximately one (1) year and one (1) month post-implantation due to dislocation caused by impingement.Attempts have been made and no further information has been provided.

• Brand Name: COMPREHENSIVE VERSA-DIAL REVERSE SHOULDER SYSTEM GLENOSPHERE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25519562
• Report Number: 0001822565-2026-01929
• Device Sequence Number: 10553700
• Product Code: PHX
• UDI-Device Identifier: 00887868231254
• UDI-Public: (01)00887868231254(17)340806(10)66774288
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: Lay User/Patient
• Device Catalogue Number: 110030776
• Device Lot Number: 66774288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male