MAUDE Adverse Event Report: Zimmer Biomet, Inc. 25MM COMP REV GLEN BSPLT REAMR; Shoulder Prosthesis, Reverse Configuration

Catalog Number	405807
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reamers were dull.There was no patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10.Concomitant medical products.Part: 405807 lot: unk.Part: 405807 lot: unk.G2: foreign - event occurred in canada.H6.Component code: mechanical (g04) - drill.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: 25MM COMP REV GLEN BSPLT REAMR
• 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: 50715878
• Report Number: 0001825034-2026-02728
• Device Sequence Number: 18658517
• Product Code: PHX
• UDI-Device Identifier: 00880304532366
• UDI-Public: 00880304532366
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405807
• Device Lot Number: Unknown
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Patient Sex: Unknown