MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92511
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively the femur was prepared with a size 11 rasp.When implant was inserted it was too small.A size 12 was needed to be implanted.There was a surgical delay of about five minutes.No adverse patient consequences reported.
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 medwatch, a follow-up medwatch will be filed as appropriate.
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.Corrected: d3, g1 (manufacturing site name).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: intraoperatively the femur was prepard with a sz.11 rasp.When implant was inserted it was too small.A sz.12 needed to be implanted.Surgical delay about 5 min.No adverse patient consequnces reported.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the corail2 std size 11 exhibits signs of implantation attempts.However, nothing indicative of a device nonconformance was observed.A manufacturing record evaluation was performed for the finished device product description: corail2 std size 11 product code: 3l92511 lot number: 5885847, and no non-conformances nor manufacturing irregularities were identified.Evidence indicates that the device had been properly measured and inspected at the manufacturer through a 100% inspection process.All relevant dimensional checks and specifications were found to be within acceptable limits at the time of release.Consequently, there is no indication of any manufacturing error that could have contributed to the reported issue.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was performed for the corail2 std size 11 and met specifications.The overall complaint was not confirmed as the observed condition of the corail2 std size 11 would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Drawing/specifications reviewed: dwg-8h200015 rev b current and manufactured.Dimensional inspection: axial length: 145 +/- 1 mm.Partial length: 45 +/- 1 mm.Measured dimensions: axial length: 145.00 mm (complies).Partial length: 45.00 mm (complies).Device used: digimatic caliper cd78619.Device history lot: (b)(4)) quantity manufactured: 30.2) date of manufacture: 05/20/2025.3) any anomalies or deviations identified in dhr: none.4) expiry date: 04/30/2030.5) ifu reference: w90918 rev.D.Device history review: a manufacturing record evaluation was performed for the finished device product description: corail2 std size 11 product code: 3l92511 lot number: 5885847, and no non-conformances nor manufacturing irregularities were identified.Corrected: h3.

• Brand Name: CORAIL2 STD SIZE 11
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : 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 IN 69801 ; FR 69801
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23706288
• Report Number: 1818910-2025-21075
• Device Sequence Number: 10641362
• Product Code: LZO
• UDI-Device Identifier: 10603295168775
• UDI-Public: (01)10603295168775(17)300430(10)5885847
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192946
• 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

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: 3L92511
• Device Lot Number: 5885847
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/05/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/13/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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
• Patient Sex: Unknown