MAUDE Adverse Event Report: DePuy Orthopaedics Inc US GLOBAL UNITE; Extremity Instruments : Stem Trials

Catalog Number	210008100
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Size 98 trial stem of consigned glenoid top tray of delta extend set was found to have bubbles in the 2 strips of plastic/painting around the top of the stem.It is believed to be a contamination concern.Product was removed off the tray and placed out of circulation.The event did not occur during a surgical procedure.Was there any reported patient or user harm? no.Was there a significant delay? no.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.

• Brand Name: GLOBAL UNITE
• Common Device Name: Extremity Instruments : Stem Trials
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50476033
• Report Number: 1818910-2026-14683
• Device Sequence Number: 16033242
• Product Code: HWT
• UDI-Device Identifier: 10603295085256
• UDI-Public: (01)10603295085256(10)7775360
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 210008100
• Device Lot Number: 7775360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown