MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Musculoskeletal problem (4535)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent a revision surgery due to pain in the left hip with a head prosthesis due metal-on-metal bearing elements causing pain, metallosis, necrosis, synovialitis and elevated cobalt and chromium in blood and urine with osteolysis in pelvis and femur.During surgery, it was noted that the inner capsule showed pronounced synovial inflammation.Fluoroscopy showed superior osteolysis up to 1 cm thick.Osteolysis of anterior column consistent with imaging was also observed along with large bony defect found medially, consistent with imaging.Affected side: left hip.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary no device associated with this report was received for examination.According to the information received,¿ on (b)(6) 2025, the patient underwent a revision surgery due to pain in the left hip with a head prosthesis due metal-on-metal bearing elements causing pain, metallosis, necrosis, synovialitis and elevated cobalt and chromium in blood and urine with osteolysis in pelvis and femur¿.Product description: - corail2 std size 12 product code: - 3l92512 lot no: - 2470430 quantity of manufactured: -(b)(4) date of manufacturing: - 23- nov-2007 expiry date: - oct-2012 ifu reference: -w90942 as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot product description: - corail2 std size 12 product code:- 3l92512 lot no:- 2470430 quantity of manufactured:- (b)(4) date of manufacturing:- 23- nov-2007 expiry date:- oct-2012 ifu reference:-w90942.Device history review a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.Corrected information: d4 (expiration, primary udi #), h4.

• Brand Name: CORAIL2 STD SIZE 12
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23369652
• Report Number: 1818910-2025-18125
• Device Sequence Number: 9950280
• Product Code: LZO
• UDI-Device Identifier: 10603295168782
• UDI-Public: (01)10603295168782(17)121001(10)84474P9
• Combination Product (Y/N): N
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2012
• Device Catalogue Number: 3L92512
• Device Lot Number: 2470430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Unknown