MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE 2.5MM PIN STERILE; PROSTHESIS, REVERSE SHOULDER

Catalog Number	47430902501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the baseplate centering pin broke off during surgery.It was not noticed during the procedure, but discovered in a followup x ray that a fragment had fractured and been retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4): d4: product id was provided for two pins however, it is unknown which of the two pins has broken.Therefore, the affected pin could be any of the following: 47430902501 - tm reverse 2.5mm pin sterile- 67353840 udi: (b)(4) manufacturing date: jul 21, 2025 expiration date: jul 15, 2035.47430902501 - tm reverse 2.5mm pin sterile - 67574693 udi: (b)(4) manufacturing date: jan 10, 2025 expiration date: sep 26, 2035.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.

• Brand Name: TM REVERSE 2.5MM PIN STERILE
• Common Device Name: PROSTHESIS, REVERSE SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25246781
• Report Number: 0001822565-2026-01675
• Device Sequence Number: 10534373
• Product Code: HSD
• UDI-Device Identifier: 00889024274273
• UDI-Public: (01)00889024274273(17)350926(10)67574693
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: Health Professional
• Device Catalogue Number: 47430902501
• Device Lot Number: 67353840
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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 Sex: Unknown