MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; SHOULDER PROSTHESIS

Catalog Number	180554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Medical device site infection (4845)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Initial right reverse total shoulder performed on an unknown date.Subsequently, it was reported that the patient was revised due to baseplate screws being broken, all implants were explanted, and a glenoid bone graft applied.Patient will be reimplanted at a later date.Glenosphere was also noted to be superiorly inclined.The glenoid baseplate had migrated superiorly due to screws breaking in the glenoid vault.This forced the glenosphere to point superiorly.Infection was also suspected.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Initial right reverse total shoulder performed on an unknown date.Subsequently, it was reported that the patient was revised due to baseplate screws being broken, all implants were explanted, and a glenoid bone graft applied.Spacer was implanted during the revision, suspected possible infection.Patient will be reimplanted at a later date.Glenosphere was also noted to be superiorly inclined.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b5; h2; h3; h6.Investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h2; h3; h6.The reported event was confirmed by review of radiographs.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of the inferior glenoid baseplate screw.Visual examination of the provided pictures identified the explanted baseplate and fractured screw(s) covered in bio-debris.No further evaluation could be made with the provided pictures.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
No further event information available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X35 ST
• Common Device Name: SHOULDER PROSTHESIS
• 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: 23321506
• Report Number: 0001825034-2025-03261
• Device Sequence Number: 15914106
• Product Code: PHX
• UDI-Device Identifier: 00880304677173
• UDI-Public: (01)00880304677173(17)271206(10)238140
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 180554
• Device Lot Number: 238140
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 03/13/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/13/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male