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

Catalog Number	010000589
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: comp rvrs shldr glnsp std 36mm cat# 115310 lot# j7569381.G2: foreign - event occurred in australia.The reported event could not be confirmed due to lack of product/information.Visual examination of the provided photos identified the explanted items.However, as the products were not returned, further analysis could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right revision tsr due to pain/impingement (notch impingement), cephalic vein injured during scar dissection ¿ tied off, illegible handwritten op note.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
It was reported the patient underwent a right reverse total shoulder revision approximately 13 months post-implantation due to impingement and pain.During the revision, notch impingement was noted.The glenosphere, humeral tray, and bearing were exchanged without complications, while the glenosphere baseplate, four screws, and humeral stem were retained.Attempts have been made and no further information has been provided.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 24571307
• Report Number: 0001825034-2026-00563
• Device Sequence Number: 9417205
• Product Code: PHX
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)340210(10)66269110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/11/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 010000589
• Device Lot Number: 66269110
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male