MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS SHL 3HOLE 56; HIP IMPLANT : ACETABULAR CUP

Catalog Number	471056300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/13/2025
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.H11 additional manufacturer narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for hip revision - infection.Device related: no information provided.Procedure related: no information provided.Date of event: 13 oct 2025.Date of implant: (b)(6) 2025.Date of revision: (b)(6) 2025.Device location: right.Treatment/impact: components removed (stem, head).Depuy synthes products used: catalog number: 101854018.Lot number: 4442962.Component type: stem.Description: reclaim monobloc revision standard stem 18 standard offset.Catalog number: 473246028.Lot number: 4838000.Component type: head.Description: emphasys 46 mm x 28 mm aox mobile bearing head.Catalog number: 472556046.Lot number: 4671538.Component type: liner.Description: emphasys 56-58 mm x 46 mm dual mobility liner.Catalog number: 471056300.Lot number: 4925729.Component type: shell.Description: emsys shl 3hole 56.Catalog number: 121735500.Lot number: pu209417.Component type: screw.Description: cancellous bone screw 35mm.Catalog number: 121745500.Lot number: pu216737.Component type: screw.Description: cancellous bone screw 45mm.Catalog number: 136528310.Lot number: 4369950.Component type: head.Description: biolox delta femoral head ceramic 28mm +1.5.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.A search of the medtech orthopaedics (nc) quality system found no nc¿s associated with this product/lot (product code: 471056300, lot -4925729) combination.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 medtech orthopaedics (nc) quality system found no nc¿s associated with this product/lot (product code: 471056300, lot -4925729) combination.H11 additional narrative: added: d10.

• Brand Name: EMSYS SHL 3HOLE 56
• Common Device Name: HIP IMPLANT : ACETABULAR CUP
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 23522961
• Report Number: 1818910-2025-19541
• Device Sequence Number: 18575177
• Product Code: LPH
• UDI-Device Identifier: 10603295500629
• UDI-Public: (01)10603295500629(17)350731(10)4925729
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• 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 Catalogue Number: 471056300
• Device Lot Number: 4925729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 28MM +1.5.; EMSYS HD AOX MB 46X28.; EMSYS LNR DM 56-58X46.; PINN CAN BONE SCREW 6.5MMX35MM.; PINN CAN BONE SCREW 6.5MMX45MM.; RECLAIM MON REV STD STEM 18 SO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 64 KG