MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	010000589
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d10: item # 20809000402, reverse shoulder augmented guide and bone model right , lot # 67147990.Item # 115396, comp rvs cntrl 6.5x30mm st/rst , lot # 67418176.Item # 180551, comp lk scr 3.5hex 4.75x20 st , lot # 67421009.Item # 180552, comp lk scr 3.5hex 4.75x25 st , lot # 67606989.Item # 180553, comp lk scr 3.5hex 4.75x30 st , lot # 67421896.Item # 115313, comp rvsr shldr glnsp +3 36mm , lot # 67131531.Item # 110030778, 40mm versa-dial glen +6 , lot # 66947356.Item # 113630, 40mm versa-dial glen +6 , lot # 67706132.Item # 110031418, cr prolong 36mm brng std , lot # 67624451.Item # 110031414, hmrl tray +6 std ti , lot # 67697176.G2: foreign - event occurred in sweden.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent a primary reverse shoulder arthroplasty and, at a follow-up visit approximately 7 weeks post-implantation, the glenosphere was found to be loosened from the baseplate.Attempts have been made and no further information has been provided.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• 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: 25409976
• Report Number: 0001825034-2026-01632
• Device Sequence Number: 10750997
• Product Code: KWS
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)350910(10)67284285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/06/2026

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: 010000589
• Device Lot Number: 67284285
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 75 KG