MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL; CORAIL IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518); Joint Laxity (4526)
Date of Event	03/18/2026
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
It was reported that on january 19, 2026, the patient underwent tha.The surgery was completed successfully with no surgical delay.On (b)(6) 2026, the patient suffered hip dislocation.The dislocation was successfully reduced manually.Since there were no problems with the placement of the implants, the surgeon decided to monitor the situation for a while.According to the surgeon, the patient fell shortly after the tha surgery and suffered greater trochanteric fractures.The fractures were treated with cables.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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- 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.Added: d3, d10 (concomitant), g1.

• Brand Name: CORAIL
• Common Device Name: CORAIL IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24793918
• Report Number: 1818910-2026-06181
• Device Sequence Number: 8646113
• Product Code: MEH
• UDI-Device Identifier: 10603295455400
• UDI-Public: (01)10603295455400(10)4944980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 04/06/2026

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: L971210
• Device Lot Number: 4944980
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 32MM +1.; PINN MAR ETO NEUT 32IDX48OD.; PINN MULTIHOLE W/GRIPTION 48MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown