MAUDE Adverse Event Report: Zimmer Biomet, Inc. Comprehensive Reverse Shoulder Glenosphere; Shoulder prosthesis, reverse configuration

Catalog Number	115313
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a reverse shoulder procedure.Subsequently, the patient had a revision procedure due to glenosphere dislocation approximately one month after surgery.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) g2: foreign - the event occurred in japan.D10: concomitant medical products, part (lot): - unknown poly bearing(unknown).H6: proposed annex g code - mechanical (g04) - head.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.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.

• Brand Name: Comprehensive Reverse Shoulder Glenosphere
• 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 ; +1(574)526-0384
• MDR Report Key: 50884332
• Report Number: 0001825034-2026-02848
• Device Sequence Number: 21317133
• Product Code: PHX
• UDI-Device Identifier: 00880304475779
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193373
• 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
• Report Date (Section B): 09/22/2026

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: 115313
• Device Lot Number: J7926830
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (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