MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND MOD EPI 2 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number	130720203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Subject id: (b)(6) study no: dots clinical adverse event received for infection.Event is serious and is considered moderate.Event is not related to device or procedure.Date of implant: (b)(6) 2024 date of event: (b)(6) 2024 (right shoulder) treatment: injected medication.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product# 130720203/lot# 5602455 combination.Additionally sterilization records were review and no issues were found.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product# 130720203/lot# 5602455 combination.Additionally sterilization records were review and no issues were found.

• Brand Name: DXTEND MOD EPI 2 ECC RIGHT HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19203083
• Report Number: 1818910-2024-09385
• Device Sequence Number: 18151198
• Product Code: KWS
• UDI-Device Identifier: 10603295027331
• UDI-Public: 10603295027331
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 130720203
• Device Lot Number: 5602455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 ECC D42MM.; DXTEND METAGLENE.; DXTEND MODULAR HUM STEM D14 HA.; DXTEND SCREW LOCK D4.5X36MM.; DXTEND SCREW LOCK D4.5X48MM.; DXTEND SCREW NO LOCK D4.5X24MM.; DXTEND SCREW NO LOCK D4.5X24MM.; DXTEND STAND PE CUP D42 +3MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 108 KG