MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS LNR DM 54X44; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number	472554044
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had multiple dislocations.All implants were removed and a reclaim monobloc was implanted with a pin revision dpx cup.Affected side : left hip.
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: d2a: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.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 manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H11 additional narrative: added: b5, d10 (concomitant).
Event or Problem Description
Additional information received: a.Was there any pc reported before for multiple dislocation? yes.B.Was there any allegation on the reported products other than the head and liner? no.

• Brand Name: EMSYS LNR DM 54X44
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 22541467
• Report Number: 1818910-2025-12429
• Device Sequence Number: 17946456
• Product Code: LZO
• UDI-Device Identifier: 10603295500889
• UDI-Public: (01)10603295500889(17)340731(10)4450138
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K231522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 472554044
• Device Lot Number: 4450138
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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: ARTICUL/EZE BALL 28 +8.5 BL.; EMSYS HD AOX MB 44X28.; EMSYS SHL 3HOLE 60.; EMSYS STEM CLRD HO 11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male