MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE® VIVACIT-E®; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031424
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Updated 10 may 2026: it was reported that the glenosphere and taper adapter separated from the baseplate following an initial shoulder arthroplasty procedure, requiring a revision approximately one (1) week later.During the revision procedure, the central screw was observed to be down, and it was noted that soft tissue may have prevented the glenosphere from properly engaging the taper, possibly due to a fall.The revision procedure was successful, and no additional harm, symptoms, or impacts were reported.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot): 110031401 (67377504).Associated product information: 010000589 (67670006), 113614 (67389515), 115310 (j7862757), 115396 (67585141), 180550 (67627409), 180551 (67696249), 180552 (67674533), 180553 (67421765), 405883 (67675220), 405889 (67479985).The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: COMPREHENSIVE® VIVACIT-E®
• 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: 25133783
• Report Number: 0001822565-2026-01506
• Device Sequence Number: 15838556
• Product Code: PHX
• UDI-Device Identifier: 00887868231551
• UDI-Public: (01)00887868231551(17)301015(10)67432864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2026

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: 110031424
• Device Lot Number: 67432864
• 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: 04/14/2026
• Initial Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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: H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 93 KG