MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 125D KLA; FEMORAL TRIALS

Catalog Number	L94004
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
It was reported that the patient underwent artificial femoral head replacement using corail femoral trials.During temporary reduction, the surgeon tried to attach a head trial to femoral trial, but they could not be attached until the click sound was heard.After that click, the surgeon was able to fit the head trial onto the femoral trial outside the surgical field by applying force with both hands.The surgeon commented that the product was defective.The hospital commented that it was possible that the stopper part (ring part) of the femoral trial was deformed (or loosened).The surgery was completed successfully, with a thirty-minute delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that on (b)(6) 2025, the patient underwent artificial bone head replacement surgery with the corail femoral trials in question.During temporary reduction, the surgeon tried to attach a head trial to femoral trial, but they could not be attached until the click sound was heard.After that, the male surgeon could attach the head trial to the femoral trial outside the surgical field by applying the force with his both hands.The surgeon commented that the product was obviously defect.The hospital commented that it was possible that the stopper part (ring part) of the femoral trial was deformed (or loosened).The surgery was completed successfully within 30minutes delay.No further information is available.The product was returned to depuy synthes for evaluation.Visual analysis of the device found that the corail amt neck seg 125d kla presents signs of repetitive use for a long period of time.Additionally, the ring is deformed.The observed condition appears to be consistent with the effects of repeated use and servicing over the time.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed with a mating head trial laboratory sample, and resistance was noted while assembling to the lcs complete revfem cem l std+.It is reasonable to conclude that the ring condition would likely impede the device from securely attach to its mating devices.Therefore, the reported allegation can be confirmed.The overall complaint was confirmed as the observed condition of the corail amt neck seg 125d kla would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot (b)(4).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.Corrected: d3, h3.

• Brand Name: CORAIL AMT NECK SEG 125D KLA
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): 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: 23826700
• Report Number: 1818910-2025-22041
• Device Sequence Number: 5031912
• Product Code: LXH
• UDI-Device Identifier: 10603295325154
• UDI-Public: (01)10603295325154(10)NB96273
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L94004
• Device Lot Number: NB96273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 01/27/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/13/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown