MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE FX RSA EPI CENTER; SHOULDER HUMERAL STEM ACCESSORY

Catalog Number	140720101
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11 additional manufacturer narrative: e1 initial reporter address line 1: kreiskrankenhaus gelnhausen herzbachweg 14.
Event or Problem Description
It was reported that both products could not be properly connected to each other.There was a remaining gap of 2cm.No appreciable op time delay.No patient damage.
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 which 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, d10 concomitant, h4.Corrected: h8.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).Investigation summary: both products could not be properly connected to each other.There was a remaining gap of 2cm.No appreciable op time delay.No patient damage.The product was returned to depuy synthes cork site for a manufacturing investigation.Visual inspection of the returned device found nothing indicative of a device nonconformance.Complaint unit: (b)(4), global unite std stem sz 10, batch 4788075, quantity: 01 it was observed that the top of the tab was damaged and therefore could not fit with the returned mating part, global unite reverse fx epi, batch: 4830638, quantity: 01.A manufacturing record evaluation was performed for the finished device 4830638 lot number, and one non-conformances was identified, no related to the reported failure mode of this complaint.Although no damage was observed on the global unite fx rsa epi center the overall was confirmed as the observed condition on the stem would have contributed to complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 24-jun-2025.3) any anomalies or deviations identified in dhr: one non conformance not related to failure mode of current complaint.4) expiry date: 5-31-2035.5) ifu reference: ifu-0902-00-850.Device history review: a manufacturing record evaluation was performed for the finished device 4830638 lot number, and one non-conformances was identified, no related to the reported failure mode of this complaint.Added: d10 (concomitant).Corrected: h3.

• Brand Name: GLOBAL UNITE FX RSA EPI CENTER
• Common Device Name: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23478940
• Report Number: 1818910-2025-19188
• Device Sequence Number: 21389335
• Product Code: PHX
• UDI-Device Identifier: 10603295444749
• UDI-Public: (01)10603295444749(10)4830638
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 140720101
• Device Lot Number: 4830638
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 01/12/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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: GLOBAL UNITE STD STEM SZ 10.; GLOBAL UNITE STD STEM SZ 10.
• Patient Sex: Unknown