MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE WITH TAPER ADAPTER; 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	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 110031425; lot# 65592671.Item# 110031411; lot# 66272761.Item# 115310; lot# j7848673.Item# 113611; lot# 66418140.G2: foreign - event occurred in japan.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.If any further information 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 the patient underwent an initial implantation of a comprehensive reverse shoulder approximately six (6) months ago.Subsequently, it was discovered during the patient's regular checkup three (3) months post-implantation that the baseplate and taper adapter disassociated.The patient later underwent a revision approximately five (5) months post-implantation.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a1; b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.Visual examination of the returned product identified the taper adaptor showed signs of use as well as wear and tear.There are scratches and gouges across the body of the device as well as scratches and gouges on the taper of the taper adaptor.A depth gauge was used to measure the height of the taper to confirm the device was conforming to the print specifications.The associated glenosphere, bearing, and tray were also returned.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left reverse total shoulder arthroplasty with disassociation of the glenosphere from the baseplate.Operative notes were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Event was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE WITH TAPER ADAPTER
• 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: 22954869
• Report Number: 0001825034-2025-02775
• Device Sequence Number: 15831512
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)340517(10)66535795
• 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: 2025
• 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): 01/21/2026

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: 66535795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male