MAUDE Adverse Event Report: DEPUY IRELAND DXTEND STAND PE CUP D42 +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number	130742209
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported intraoperatively it was not possible to fix the inlay into the size 10 monobloc implant.Another inlay was available and used without issue.No patient harm and no surgical delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event provided 5728316 was not able to be validated, the full udi is currently not available.
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 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 intraoperatively it was not possible to fix the inlay into the size 10 monobloc implant.Another inlay was available and used without issue.No patient harm, no surgical delay reported.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the dxtend stand pe cup d42 +9mm displays marks and slight deformations on the surface which are typical for a cup that has attempted to be placed on the monobloc stem.However, nothing indicative of a device nonconformance was observed.As per delta xtend surgical technique, "after thorough cleaning impact the final humeral cup using the cup impactor.When a humeral spacer is needed impact it first on the epiphysis and then impact the final cup on it".It is worth mentioning that "all junction surfaces between the implant components should be clean and free of any tissue before impaction".A manufacturing record evaluation was performed for the finished device [130742209/ 5728316] and no non-conformances / manufacturing irregularities were identified.A functional test was not able to be performed since the mating device was not returned.In addition, nothing indicative of a device nonconformance could be identified on the device that could have been related to a difficulty or inability to assemble the mating component as intended.A dimensional inspection was performed for the dxtend stand pe cup d42 +9mm and met specifications.The overall complaint was not confirmed as the observed condition of the dxtend stand pe cup d42 +9mm would not have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Drawing/specifications reviewed: dwg-8e070156 rev.D current and manufactured.Dimensional inspection: specified dimensions: gauge ø = 32.35 mm ± 0.04 mm, width of slot = 3 mm ± 0.5 mm, cup ø = 42 mm ± 0.15 mm, groove ø = 31.45 mm ± 0.5 mm, groove edge ø = 32.95 mm +0.10 mm.Measured dimensions: gauge ø = 32.37 mm (complies), width of slot = 3.01 mm (complies), cup ø = 41.98 mm (complies), groove ø = 31.64 mm (complies), groove edge ø = 32.99 mm (complies).Device used ¿ digimatic caliper cd78620.Device history lot 1) quantity manufactured: (b)(4) 2) date of manufacture: 6/27/2024 3) any anomalies or deviations identified in dhr: none 4) expiry date: 5/31/2029 5) ifu reference: w90930 rev.D.Device history review a manufacturing record evaluation was performed for the finished device [130742209/ 5728316] and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d4 (expiry date), h4 corrected: h3.

• Brand Name: DXTEND STAND PE CUP D42 +9MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• 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: 23008707
• Report Number: 1818910-2025-15527
• Device Sequence Number: 18767574
• Product Code: HSD
• UDI-Device Identifier: 10603295027553
• UDI-Public: (01)10603295027553
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192855
• 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: 130742209
• Device Lot Number: 5728316
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 11/18/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/18/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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
• Patient Sex: Unknown