MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Catalog Number	113042
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Periprosthetic fracture (4902)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in australia.H6: proposed annex g mechanical (g04) - head.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: associated product information, part (lot): -unknown glenoid (unknown).The customer has not indicated whether the product will be zimmer biomet for investigation, and 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 is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the patient underwent a revision approximately three months post-implantation due to subscapularis failure attributed to patient noncompliance leading to a component dislocation.During the revision, the surgeon changed the head to a smaller size.It was reported that no further information is available.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD
• Common Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
• 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: 25415199
• Report Number: 0001825034-2026-01633
• Device Sequence Number: 17602337
• Product Code: MBF
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)331002(10)66070458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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?: No
• Device Catalogue Number: 113042
• Device Lot Number: 66070458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown