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

Catalog Number	3L92501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision total hip replacement.The corail stem has fractured at the neck region.Stem originally implanted on (b)(6) 2017.According to the surgeon the patient did not have a fall, was simply stretching to put his pants on and felt it give way.Surgeon also stated that the patients posterior hip capsule was deficient.The patient had previously complained of groin pain and had seen 2 other surgeons in relation to this for hip arthroscopy¿s where they performed psoas tendon releases.Stem was very well fixed and took considerable effort to remove from the femoral canal.Patients original surgery was for a hemiarthroplasty bipolar for a fractured neck of femur.This was later revised to a total hip with the femoral stem left insitu and the acetabular converted from a bipolar to a pinnacle thr.
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.H11 additional manufacturer narrative: h3, h6: 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.The product was not returned to j&j medtech orthopaedics; however photos were provided for review.The x-ray and photo investigation revealed that the corail amt collar size 11 has fractured at the neck section.Additionally, the femoral stem presents sings of organic material and what appears to be bone ingrowth adhered to the fixation surface.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the corail amt collar size 11 would have contributed to the complained 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.
Event or Problem Description
Additional information was received and states that: "the event was very traumatic leading to emergency hip revision surgery, six nights in hospital, ongoing medical and rehabilitation expenses as well as significant pain and suffering which l am in the midst of.".
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 that 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: b5.If information that was not available for the initial report is obtained, 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 (concomitant).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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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 recon described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: revision total hip replacement - corail stem has fractured at the neck region.Stem originally implanted on (b)(6) 2017.According to the surgeon the patient did not have a fall, was simply stretching to put his pants on and felt it give way.Surgeon also stated that the patients posterior hip capsule was deficient.The patient had previously complained of groin pain and had seen 2 other surgeons in relation to this for hip arthroscopy¿s where they performed psoas tendon releases.Stem was very well fixed and took considerable effort to remove from the femoral canal.Patients original surgery was for a hemiarthroplasty bipolar for a fractured neck of femur.This was later revised to a total hip with the femoral stem left insitu and the acetabular converted from a bipolar to a pinnacle thr.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the corail amt collar size 11 presents sings of organic material and what appears to be bone ingrowth adhered to the fixation surface.Additionally the device was fractured from the neck section, the fractured fragment was returned assemble with the ceramic head.The majority of the fracture surface exhibited fatigue characteristics, which is consistent with clearly a low stress high cycle fatigue.There is no indication that a material or manufacturing issue has caused or contributed to the reported event.However, a definite root cause cannot be established due to there being multiple factors that may influence implant failure.Consideration must be given to all potential influences including but not limited to surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device product description: corail amt collar size 11 product code: 3l92501 lot number: 5282532 and no non-conformances or manufacturing irregularities were identified.A functional test was unable to be performed due to the post-manufacturing damage.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the corail amt collar size 11 would have contributed to the complained 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.Device history lot: a manufacturing record evaluation was performed for the finished device product description: corail amt collar size 11 product code: 3l92501 lot number: 5282532 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: corail amt collar size 11 product code: 3l92501 lot number: 5282532 and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: d4 (exp.Date & primary udi number), h4.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: revision total hip replacement - corail stem has fractured at the neck region.Stem originally implanted on (b)(6) 2017.According to the surgeon the patient did not have a fall, was simply stretching to put his pants on and felt it give way.Surgeon also stated that the patients posterior hip capsule was deficient.The patient had previously complained of groin pain and had seen 2 other surgeons in relation to this for hip arthroscopy¿s where they performed psoas tendon releases.Stem was very well fixed and took considerable effort to remove from the femoral canal.Patients original surgery was for a hemiarthroplasty bipolar for a fractured neck of femur.This was later revised to a total hip with the femoral stem left insitu and the acetabular converted from a bipolar to a pinnacle thr.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The x-ray and photo investigation revealed that the corail amt collar size 11 has fractured at the neck section.Additionally, the femoral stem presents sings of organic material and what appears to be bone ingrowth adhered to the fixation surface.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the corail amt collar size 11 would have contributed to the complained 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 manufacturing record evaluation was performed for the finished device product description: corail amt collar size 11 product code: 3l92501 lot number: 5282532 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: CORAIL AMT COLLAR 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22814011
• Report Number: 1818910-2025-14247
• Device Sequence Number: 21086102
• Product Code: LZO
• UDI-Device Identifier: 10603295168676
• UDI-Public: (01)10603295168676(17)211031(10)5282532
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• 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,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 Expiration Date: 10/31/2021
• Device Catalogue Number: 3L92501
• Device Lot Number: 5282532
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/19/2025; 10/07/2025; 11/26/2025; 01/20/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/22/2025; 10/08/2025; 11/27/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2016
• 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: DLT TS CER HD 12/14 36MM +12.; EA DELTA CER INSERT 36IDX54OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 81 KG