MAUDE Adverse Event Report: DEPUY FRANCE SAS CORAIL2 LAT COXA VARA SIZE 14; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L93714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pocket Erosion (2013); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on february 15, 2012, the patient received a right anterior approach total hip arthroplasty to address right hip osteoarthritis.Metal on metal implants were implanted.There were no complications.On (b)(6) 2024, patient's right hip was revised to address alval pseudotumor, metallosis, osseus bone erosions, and osteolysis.The metal insert and head were replaced with a dual mobility liner construct.There were no complications.On (b)(6) 2024, the patient's right hip was revised again to address purulent wound drainage, possible infection versus alval lesion.Cultures obtained were inconsistent with infection, so the diagnosis leaned in favor of alval, subsequent to the previous revision.Surgeon revised and replaced the femoral head and the dual mobility metal and poly liners, retaining the acetabular cup and femoral stem.And extensive irrigation and debridement were performed.There were no complications.This report captures the revision procedure on (b)(6) 2024.The second revision is captured on related complaint (b)(4).Doi: (b)(6) 2012.Dor: (b)(6) 2024.(acetabular liner, cup & femoral head,) right hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: no device associated with this report was received for examination.Product description:- corail2 lat coxa vara size 14.Product code:- 3l93714.Lot no:- 5110431.Quantity of manufactured:- (b)(4).Date of manufacturing:- oct-2011.Expiry date:- sep-2016.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 lat coxa vara size 14.Product code:- 3l93714.Lot no:- 5110431.Quantity of manufactured:- (b)(4).Date of manufacturing:- oct-2011.Expiry date:- sep-2016.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.H11 additional narrative: added: d10.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 14
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22161659
• Report Number: 1818910-2025-09274
• Device Sequence Number: 15804764
• Product Code: LZO
• UDI-Device Identifier: 10603295168911
• UDI-Public: (01)10603295168911(17)160901(10)5110431
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 09/01/2016
• Device Catalogue Number: 3L93714
• Device Lot Number: 5110431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2011
• 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: 12/14 ARTICUL 44MM M SPEC+5; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX45MM; PINNACLE MTL INS NEUT44IDX62OD; PINNACLE SECTOR II CUP 62MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male