MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92512
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.Additional narrative: investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not performed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported a revision surgery occurred on (b)(6) 2025 due pain and aseptic loosening of the femoral stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.According to the information received, ¿aseptic loosening of the femoral stem¿.Product description:- corail2 std size 12 product code:- 3l92512.Lot no:- 5013559.Quantity of manufactured:- (b)(4).Date of manufacturing:- oct-2009.Expiry date:- sept-2014.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:- 5013559.Quantity of manufactured:- (b)(4).Date of manufacturing:- oct-2009.Expiry date:- sept-2014.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: CORAIL2 STD SIZE 12
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 22118060
• Report Number: 1818910-2025-08813
• Device Sequence Number: 6950677
• Product Code: LZO
• UDI-Device Identifier: 10603295168782
• UDI-Public: (01)10603295168782(17)140901(10)5013559
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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

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: 09/01/2014
• Device Catalogue Number: 3L92512
• Device Lot Number: 5013559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2009
• 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 Sex: Male