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

Catalog Number	110031427
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Joint Impingement (4834)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: item# 110030778; lot# 65967075 item# 118000; lot# 67690145 item# sahtne00; lot# 67710926 e1: full establishment name - (b)(6) hospital.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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 by the pmi group that a patient underwent a previous revision due to impingement and dislocation where standard implants were used.Subsequently, the patient is being considered for a custom pmi product on an unknown day to revise the glenosphere due to joint laxity and impingement on the anterior edge of the vrs baseplate, causing instability.Attempts have been made and no further information has been provided.

• Brand Name: COMPREHENSIVE VERSA-DIAL REVERSE SHOULDER SYSTEM VIVACIT-E BEARING
• 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: 25360085
• Report Number: 0001822565-2026-01752
• Device Sequence Number: 18811297
• Product Code: PHX
• UDI-Device Identifier: 00887868231582
• UDI-Public: (01)00887868231582(17)280726(10)65994920
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 110031427
• Device Lot Number: 65994920
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male