MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 LAT COXA VARA SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Hematoma (1884); Limb Fracture (4518); Unspecified Tissue Injury (4559)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to obtain the legal contact information.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
Medical records received.After review of medical records, it was reported that the patient fell sustaining the aforementioned periprosthetic hip fracture.Patient also had 3 previous dislocation event.The patient was then revised for right periprosthetic proximal femur fracture and metal on metal tha components with extensive metallosis and soft tissue necrosis.Operative notes indicate that a extensive hematoma was encounter.It was noted that no fascia present as there was a direct line from the hematoma into the joint hip.It appeared that there was extensive metallosis and soft tissue necrosis likely related to the metal on metal articulation.The posterior aspect of the greater trochanter was noted to be denuded of the soft tissue attachment.It was indicated that stem was stable and only the greater trochanter was fractured and fragmented.There was noted to be some metallosis along the trunnion.Doi: (b)(6) 2007.Dor: (b)(6) 2021.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 15
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• MDR Report Key: 12089015
• Report Number: 1818910-2021-13841
• Device Sequence Number: 14318891
• Product Code: LZO
• UDI-Device Identifier: 10603295168928
• UDI-Public: 10603295168928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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 Model Number: 3L93715
• Device Catalogue Number: 3L93715
• Device Lot Number: 2124021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/14 ARTICUL 44MM M SPEC+12; CORAIL2 LAT COXA VARA SIZE 15; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 62MM; PINNACLE MTL INS NEUT44IDX62OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR