MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92511
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent total hip replacement on (b)(6) 2024.On (b)(6) 2024, the secondary surgery was performed to patient due to post op pain.The patient is currently stable.There was no surgical delay.Affected side: left side.
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: b5, d4 (expiry date), d10 (concomitant), h4.Corrected: d3, d4 (primary udi number), g1 (manufacturing site name), h6 (medical device problem code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received from sales rep via phone today.After investigation, the patient underwent total hip arthroplasty due to "osteoarthritis" on (b)(6) 2024.Corail femoral stem and supporting products were implanted during the surgery, and the surgery went smoothly.Postoperative rehabilitation is unknown.Postoperatively, the patient presented to the hospital with pain (exact date unknown) and an x-ray showed no abnormalities with the prosthesis.On (b)(6) 2024, the patient went to the hospital for a second surgery due to severe pain to remove the prosthesis and replace a new product.It was observed that the coating fell off on the removed femoral stem.The specific surgical process was unknown.At present, the patient's condition was stable, and the pain symptoms were improved.No subsequent adverse event report was received.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Product description:-- corail2 std size 11 product code:- 3l92511 lot no:- 5419390 quantity of manufactured:- 30 date of manufacturing:- 12-oct-2022 expiry date:- 30-sep-2027 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 11 product code:- 3l92511 lot no:- 5419390 quantity of manufactured:- 30 date of manufacturing:- 12-oct-2022 expiry date:- 30-sep-2027 device history review a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: CORAIL2 STD 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21150422
• Report Number: 1818910-2025-00836
• Device Sequence Number: 21129633
• Product Code: LZO
• UDI-Device Identifier: 10603295168775
• UDI-Public: (01)10603295168775(17)270930(10)5419390
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3L92511
• Device Lot Number: 5419390
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/21/2025; 02/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/28/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2022
• 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: UNKNOWN HIP FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown