MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE STD STEM SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	110010100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Doing a global unite reverse total shoulder (left); stem and epi would not mate.Seems to be a mismatch or machining issue.Another stem and epi were opened and the combination worked as expected.Procedure was completed successfully with a five-minute delay.There was no patient consequence.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added : d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- according to the information received, ¿doing a global unite reverse total shoulder, stem and epi would not mate.Seems to be a mismatch or machining issue¿.The reported global unite std stem sz 10 (lot.4554806) and photos of the product labels were returned to depuy synthes for evaluation.The depuy synthes team forwarded all the available information to the manufacturing site for further evaluation.Based on the manufacturing investigation, it was confirmed that the tab (assembly feature) width was out of the maximum tolerance limit; this dimensional non-conformance prevents the implant from properly assembling with its corresponding mating part.Additionally, the visual inspection performed under standard magnification revealed that the tab surface exhibited machining marks consistent with the use of a damaged tool during the manufacturing process.This condition could not have been caused by external forces acting on the part.The overall complaint was confirmed as the observed condition of the global unite std stem sz 10 would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a manufacturing record evaluation was performed for the finished device [lot, 4554806] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.However, an nr and capa have been initiated to address the reported complaint condition.Device history batch- null.Device history review- a manufacturing record evaluation was performed for the finished device [lot, 4554806] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.However, an nr and capa have been initiated to address the reported complaint condition.Added: d10 concomitant corrected: d9 ( date device returned to manufacturer), h3.

• Brand Name: GLOBAL UNITE STD STEM SZ 10
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22116939
• Report Number: 1818910-2025-08794
• Device Sequence Number: 4251126
• Product Code: HSD
• UDI-Device Identifier: 10603295004080
• UDI-Public: (01)10603295004080(17)20340731(10)4554806
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 110010100
• Device Lot Number: 4554806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 03/17/2026
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/05/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: XTEND MODECC 145EPI POR SZ1 LT.
• Patient Sex: Unknown