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

Catalog Number	L971211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
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 (b)(6) 2024, the patient underwent bilateral tha.The surgery was completed successfully without any surgical delay.Two years after the surgery, cracks at the stem necks were identified on radiographic imaging.The patient is a ballet dancer and was able to perform ballet movements, including abduction; however, it was reported that a sound suggestive of implant impingement occurred when the hip was brought to maximum abduction.At present, the patient reports no pain or functional issues.No implants have been removed.
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: there is 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: d10 concomitant.Corrected: d3, 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 IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25256840
• Report Number: 1818910-2026-09152
• Device Sequence Number: 5431923
• Product Code: MEH
• UDI-Device Identifier: 10603295478621
• UDI-Public: (01)10603295478621(17)280831(10)4201669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213839
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: L971211
• Device Lot Number: 4201669
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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: CORAIL AMT SZ11 STD COL; CORAIL AMT SZ11 STD COL; CORAIL AMT SZ11 STD COL; CORAIL AMT SZ11 STD COL; DELTA CER HEAD 12/14 28MM +1.5; DELTA CER HEAD 12/14 28MM +1.5; DELTA CER HEAD 12/14 28MM +1.5; DELTA CER HEAD 12/14 28MM +1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female