MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92510
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgery is performed normally.The implant is tested and, once the doctor decides the size of the definitive implant, they proceed to open and pass the implant for placement.However, after impacting several times, the implant does not enter and becomes trapped.Subsequently, the ta proceeds to review and realizes that the characteristics of the implant do not coincide with those of its packaging.The box was closed, with its protective plastic.Once the primary packaging is opened and after the incident, the packaging where the sterile stem comes is checked, which is without its usual labels; only a small label is seen.Therefore, labels, packaging and stem do not match.Procedure was completed successfully with a delay of twenty minutes.There was no patient consequence.
Additional Manufacturer Narrative
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.
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: d10, h6 (health effect - impact code).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).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: d10.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: surgery is performed normally.The implant is tested and, once the doctor decides the size of the definitive implant, they proceed to open and pass the implant for placement.However, after impacting several times, the implant does not enter and becomes trapped.Subsequently, our ta proceeds to review and realizes that the characteristics of the implant do not coincide with those of its packaging.The box was closed, with its protective plastic.Once the primary packaging is opened and after the incident, the packaging where the sterile stem comes is checked, which is without its usual labels; only a small label is seen.Therefore, labels, packaging and stem do not match.Photos were provided for review.The photo investigation revealed that the outer label information did not match with the inner label and implant.The observed condition of the implant is consistent with the implantation attempt as reported.Following the analysis, it was determined that the internal packaging elements originated from a batch of corail stems manufactured by viant chaumont.However, it is evident that the external packaging, specifically the box in which the implant was received is not the original one.The external label does not correspond to a stem manufactured by viant chaumont, and further discrepancies were observed.Notably, the condition of the patient label found on the tyvek suggests a probably mix-up between two corail stems of different sizes (size 10 vs.Size 12) and different origins (cork vs.Chaumont), with different and very distant dates of manufacture (2021 vs.2014).After further investigation in the distribution center process, it is suspected the mix up could have occurred outside j&j's control.Within j&j's control there was no rework of these lots and all shrink wrap was intact before leaving the loc and distribution center.Therefore, since there was manipulation of the package, the mix-up must have occurred only outside of j&j's control.Once the product leaves j&j's control, it is unknown what conditions or human intervention or manipulation the packaged products are exposed to.However, without additional information or evidence the cause for mix up cannot be traced to viant or cork manufacturing and therefore must have occurred some time after distribution.The overall complaint was confirmed as the observed condition of the corail2 std size 10 package would have 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 j&j medtech orthopaedics 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: a search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: CORAIL2 STD SIZE 10
• 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 69801 ; FR 69801
• 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: 22091077
• Report Number: 1818910-2025-08540
• Device Sequence Number: 15184925
• Product Code: LZO
• UDI-Device Identifier: 10603295168768
• UDI-Public: (01)10603295168768(17)20260831(10)9841774
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,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 Expiration Date: 08/31/2026
• Device Catalogue Number: 3L92510
• Device Lot Number: 9841774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 06/04/2025; 08/04/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/02/2025; 06/13/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2021
• 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: CORAIL2 STD SIZE 10.; CORAIL2 STD SIZE 10.
• Patient Sex: Unknown