MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	130710000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that patient underwent removal of delta xtend due to infection.Doi: unknown 2015.Dor: (b)(6) 2025.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: removal of infected delta xtend.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.Based on the information provided, the photo and x-ray investigation revealed nothing indicative of a device nonconformance.The photographs show the explanted devices with what appears to be biological material adhered.A manufacturing record evaluation was performed for the finished device product code 130710000 lot number 5245165, and no non-conformances / manufacturing irregularities were identified during manufacturing.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the dxtend modular hum stem d10 ha would have not contributed to 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 reported complaint condition.As part of j&j medtech orthopaedics 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: a manufacturing record evaluation was performed for the finished device product code 130710000 lot number 5245165, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device product code 130710000 lot number 5245165, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: added: d10.

• Brand Name: DXTEND MODULAR HUM STEM D10 HA
• Common Device Name: DELTA XTEND 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: 22462401
• Report Number: 1818910-2025-11733
• Device Sequence Number: 12765260
• Product Code: KWS
• UDI-Device Identifier: 10603295027126
• UDI-Public: (01)10603295027126(17)20200101(10)5245165
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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

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 Expiration Date: 01/01/2020
• Device Catalogue Number: 130710000
• Device Lot Number: 5245165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2015
• 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: DXTEND GLENOSPHERE STD D38MM.; DXTEND HIGHMO PE CUP D38 +3MM.; DXTEND METAGLENE.; DXTEND MOD CENT EPI 1 HA.; DXTEND SCREW LOCK D4.5X30MM.; DXTEND SCREW LOCK D4.5X36MM.; DXTEND SCREW LOCK D4.5X42MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female