MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA XTEND; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number	130738203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dxtend stand pe cup d38 +3mm was involved in an event concerning scapular notching following a reverse shoulder arthroplasty.The patient underwent a revision surgery to replace the glenosphere, epiphysis, and polyethylene cup.Affected side: left shoulder.
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.
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: d10 concomitant.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: it was reported that the patient had a delta xtend on 01-14-25.She implanted of scapula notching.So, doctor performed shoulder revision surgery to change out the glenoshpere, epiphysis and poly.The product was not returned to depuy synthes; however, photo was provided for review.(b)(4).The photograph attached was reviewed, however does not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photograph provided is not representative of the reported adverse event.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 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA XTEND
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• 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: 24857435
• Report Number: 1818910-2026-06666
• Device Sequence Number: 9367500
• Product Code: HSD
• UDI-Device Identifier: 10603295027362
• UDI-Public: (01)10603295027362(17)290831(10)5758331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 130738203
• Device Lot Number: 5758331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 04/17/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/15/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: X-LINK HIMO HUM CUP 38+3.; X-LINK HIMO HUM CUP 38+3.; XTEND MOD CEN 155EPI POR SZ1.; XTEND MOD CEN 155EPI POR SZ1.; XTNDGLENO D38MM +0MM SHRTPST.; XTNDGLENO D38MM +0MM SHRTPST.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female