| Catalog Number |
3L92515 |
| Medical Device Problem Code |
Fracture (1260)
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| Health Effect - Clinical Codes |
Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
11/07/2025
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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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.Additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event or Problem Description
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It was reported the surgeon reported that unilateral implant fracture occurred two years postoperatively.Revision occurred on (b)(6) 2025.
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Additional Manufacturer Narrative
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Product complaint #
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> (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 hat 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 and d10 corrected: h6 (health effect - clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event or Problem Description
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Additional information received states that "on 07.11.2025.While the patient was in podgorica, montenegro and was walking down the street in the usual walk, without any external cause, trauma or unusual physical strain, there was a sudden and complete fracture of the right hip endoprosthesis, which the patient fell to pavement, which required urgent medical intervention and hospitalization.The patient was then transported to (b)(6), serbia where he was reoperated on (b)(6) 2025.By the same doctor who performed the initial operation, the broken endoprosthesis was removed and replaced by a new one.The patient is currently in the postoperative recovery phase.Please note that, in order to fully clarify the circumstances of this event, complete medical documentation and post-operative radiological recordings were analyzed after the first operation, with no elements were identified indicating a fault in surgical procedure or improper implantation of endoprosthesis.".
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Additional Manufacturer Narrative
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Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, prt 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 hat 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: corrected: h1 (initial reporter country code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the surgeon reported that unilateral implant fracture occurred two years postoperatively.The product was not returned to depuy synthes, however photos were provided for review.See attachment "_external_ prelom komponenti proteze 10_11_25_".Thex-ray investigation revealed that the corail2 std size 15 neck is fractured, confirming the reporting event.No other anomaly was identified on the evidence provided.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.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the corail2 std size 15 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 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 3l92515/ 5565957 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.Corrected: d3, g1.
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Additional Manufacturer Narrative
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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 hat 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.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the surgeon reported that unilateral implant fracture occurred two years postoperatively.The product was returned to depuy synthes for evaluation.Visual inspection reveled that the corail2 std size 15 was fractured at the neck section, the fractured surfaces exhibits evidence of low stress high cycle fatigue.Additionally, there appears to be cautery damage to the steam and therefore may have played a role in the fracture.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.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device 3l92515/5565957 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the corail2 std size 15 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 3l92515/5565957 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.Corrected: h3.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the surgeon reported that unilateral implant fracture occurred two years postoperatively.The product was not returned to depuy synthes; however, photos were provided for review.Thex-ray investigation revealed that the corail2 std size 15 neck is fractured, confirming the reporting event.No other anomaly was identified on the evidence provided.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.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the corail2 std size 15 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 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 3l92515/5565957 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary the surgeon reported that unilateral implant fracture occurred two years postoperatively.The product was returned to depuy synthes for evaluation.The complaint unit was forwarded was forwarded to the depuy synthes material science lab in warsaw for further evaluation.Visual inspection reveled that a corail 135° standard hip stem (size 15) was received with a fractured femoral neck.All fractured pieces were received.The proximal and distal fracture surfaces were evaluated optically, with digital microscopy, and with scanning electron microscopy (sem).The fracture surfaces exhibited regions of some burnishing with greater damage observed anterolaterally.However, beach marks and striations were observed consistent with fatigue fracture.Striations and river marks observed in various areas were consistent with an anterolateral fatigue initiation.Due to the damage and burnishing, an exact initiation site could not be identified.The vast majority of the fracture surface (>90%) exhibited fracture features consistent with fatigue crack propagation, with the posterior and medial regions showing shear and ductile dimples consistent with a final ductile overload fracture.This is consistent with low stress high cycle fatigue as higher stresses would result in a larger overload region.Damage with blue, purple, and brown discoloration, localized melting, and/or surface oxidation was observed on many surfaces of the stem, including on the fracture surfaces, consistent with cautery damage.The damage on the fracture surfaces indicate at least some of the cautery damage occurred during revision explanation.Damage of the anterolateral polished surface of the stem¿s neck was observed, most notably coincident to the initiation region both proximal and distal to the fracture surface.Although it is not possible to determine whether this damage occurred during the primary or revision surgery, with the immediate adjacency to the fracture initiation region, it appears likely the damage occurred during primary surgery and therefore acted as a local stress riser, likely contributing to fracture initiation.In summary, cyclic loading exceeded the material fatigue limit, producing fatigue crack initiation and propagation that culminated in final ductile overload fracture.Features consistent with cautery damage were noted on the anterolateral surface of the stem¿s neck.Although it is not possible to determine whether this damage occurred during the primary or revision surgery, with the immediate adjacency to the fracture initiation region, it appears likely the damage occurred during primary surgery and therefore acted as a local stress riser, likely contributing to fracture initiation.The fracture morphology is consistent with low-stress, high-cycle fatigue with anterolateral initiation.No material or manufacturing defects were identified (other than the damage consistent with cautery damage) that could have contributed to initiation and/or propagation to failure.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.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device 3l92515/ 5565957 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the corail2 std size 15 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
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> a manufacturing record evaluation was performed for the finished device 3l92515/ 5565957 number, and no non-conformances or manufacturing irregularities related to the complaint condition were identified.
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