MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL REVISION STEM HO 11; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Catalog Number	L98111
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted with a stem ph revis tige cim corail ho t11 185 mm.On an unknown date in 2023 driving in of the stem with rupture of the distal 1/3.No functional resentment.The patient did not wish to have surgery because there was no gene.No sensation was noted.In 2025, the patient returned for a check-up regarding the left hip prosthesis.Patient was in a significant pain, difficulty walking, with a tilt of the stem observed due to a kar fracture on the x-ray.Patient was revised with hip prosthesis -change of femoral rod (left)/general anesthesia.Affected side: left.
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).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H11 additional narrative: added: d10.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: placement of date#1 of a stem ph revis tige cim corail ho t11 185mm.On date#2, the stem was inserted with a rupture of the distal third.No sensation was noted.On date#3, returns for a check-up regarding the left hip prosthesis.Patient is in significant pain, difficulty walking, with a tilt of the stem observed due to a kar fracture on the x-ray.Revised hip prosthesis - change of femoral rod (left) / general anesthesia + scheduled block on date#4.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photographs attached were reviewed, however they do not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.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.A manufacturing record evaluation was performed for the finished device product description: corail revision stem ho 11 product code: l98111 lot number: 5347838 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint.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 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 revision stem ho 11 product code: l98111 lot number: 5347838 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 revision stem ho 11 product code: l98111 lot number: 5347838 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: CORAIL REVISION STEM HO 11
• Common Device Name: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22375330
• Report Number: 1818910-2025-11048
• Device Sequence Number: 14562165
• Product Code: LZO
• UDI-Device Identifier: 10603295262398
• UDI-Public: (01)10603295262398(17)240630(10)5347838
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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

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: 06/30/2024
• Device Catalogue Number: L98111
• Device Lot Number: 5347838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/06/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/10/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2019
• 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: CORAIL REVISION STEM HO 11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown