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

Catalog Number	110032430
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products, part (lot): 110032430 (65516699) unknown 4.75 mm fixed screw (unknown).Unknown 4.75 mm fixed screw (unknown).Unknown 6.5 mm central screw (unknown).Associated product information: 113631 (66324286).Xl-115363 (66265403).115310 (j7594618).115370 (66636390).G2: foreign - the event occurred in the united kingdom.The customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found 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 a patient underwent a revision reverse shoulder arthroplasty approximately one (1) year and seven (7) months after implantation following shoulder pain.Post-operative radiographs demonstrated multiple fractured fixation screws and loosening of the augmented glenoid baseplate.During the revision procedure, all broken screw fragments were removed, the glenoid was bone grafted, and the failed baseplate and associated components were replaced.No evidence of infection or trauma was reported.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: ap radiographs of the right reverse total shoulder arthroplasty with the humerus in internal and external rotation show that the three (3) screws associated with the baseplate component are fractured.Radiolucency at the superior-most screw-metal bone interface suggests loosening of this screw.The baseplate component has migrated superolaterally from the glenoid.The humeral component appears intact and grossly unremarkable.The device history record was reviewed, and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE® REVERSE SHOULDER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23582944
• Report Number: 0001825034-2025-03676
• Device Sequence Number: 9305039
• Product Code: PHX
• UDI-Device Identifier: 00880304993259
• UDI-Public: (01)00880304993259(17)270830(10)65516699
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 110032430
• Device Lot Number: 65516699
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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 Sex: Male