MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE POROCOAT STANDARD STEM SIZE 12 120MM; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	110012100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 narrative: d4: udi: as a valid lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that it was not possible to connect the epiphysis at the stem´s proximal peg.Another stem was used without any issue.There was no surgical delay and no adverse patient consequences were reported.Surgery was finished successfully.
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: d4 (lot, expiration), h4.Corrected: d4 (primary udi #).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 recon 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 provided: "hcp is reporting that it was not possible to connect the epiphysis at the stem´s proximal peg.Another stem was used without any issue.No surgical delay, no adverse patient consequences reported.Surgery was finished successfully".The product was returned to depuy synthes cork site for a manufacturing investigation.Visual inspection of the returned device was able to confirm the reported event, as the tab width was out of specification (too wide), condition that impedes an intended assembly.The assignable cause was due to a human error, as the inspection of the tab width was not carried out correctly.Complaint failure mode was traced to a malfunction between the mating device with its counterpart.There is no expected impact on the sterility of unit or the integrity of sterile barrier based on the complaint investigation.A manufacturing record evaluation was performed for the finished device 4788135 lot number, and two non-conformances were identified associated to the reported failure mode of this complaint.The overall complaint was confirmed as the observed condition of the global unite std stem sz 12 would have contributed 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: 1) quantity manufactured: 9.2) date of manufacture: 02-may-2025.3) any anomalies or deviations identified in dhr: 2 non-conformances associated to the.Failure mode of this complaint.4) expiry date: 30-apr-2035.5) ifu reference: ifu-0902-00-850.Device history review: a manufacturing record evaluation was performed for the finished device 4788135 lot number, and two non-conformances were identified associated to the reported failure mode of this complaint.Corrected: h3.

• Brand Name: GLOBAL UNITE POROCOAT STANDARD STEM SIZE 12 120MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23434573
• Report Number: 1818910-2025-18509
• Device Sequence Number: 21004919
• Product Code: HSD
• UDI-Device Identifier: 10603295004127
• UDI-Public: (01)10603295004127(17)350430(10)4788135
• 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: Physician
• Type of Report: Initial,Followup,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: 110012100
• Device Lot Number: 4788135
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 12/30/2025; 01/05/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/31/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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
• Patient Sex: Unknown