MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 LAT COXA VARA SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).The initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient initiated complaint as follows: i am reaching out to share what if feel is really important information with you.My journey as a hip replacement surgery began in (b)(6) 2018 when i had my initial right hip surgery.I recovered very well no issues until (b)(6), 2023 (b)(6), 2023, my hip began to "squeak" like an old screen door.I was unable to walk without experiencing pain and every step induced a squeaky step.My original surgeon has since retired so the next available appointment was wednesday (b)(6) at which time it was decided that there was a malfunction to my hip replacement which is less than 5 years old.(b)(6) 2023, i have a re-do of my original hip replacement spent two days inpatient and followed up with post op physical therapy.I did follow up with my routine 2 week appointment and all was going well.Doi: (b)(6), 2018.Dor: (b)(6), 2023.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.The photographs and video attached were reviewed.However, they do not represent the current complaint condition and event.Therefore, the investigation could not draw any conclusions about the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed, for the finished device lot#: 5301961.And no nonconformances were identified.
Event or Problem Description
Additional information received: on (b)(6) 2018 patient underwent a right tha.On (b)(6) 2023: patient began experiencing squeaking (no pain).On (b)(6) 2023: the patient underwent a revision for squeaking.(b)(4) on (b)(6) 2023: patient dislocated while getting up from a couch and experienced pain.The patient underwent a closed reduction under sedation on (b)(6) 2023.The patient was placed in a leg brace due to continued instability which indicated the need for another revision.On (b)(6) 2023: the patient underwent a second revision.(b)(4).
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Removed date of explant since there was no indication that the stem was revised.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 10
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16706868
• Report Number: 1818910-2023-07552
• Device Sequence Number: 11672730
• Product Code: LZO
• UDI-Device Identifier: 10603295168874
• UDI-Public: 10603295168874
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2023

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 Model Number: 3L93710
• Device Catalogue Number: 3L93710
• Device Lot Number: 5301961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 05/25/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/09/2023; 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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: ALTRX NEUT 32IDX50OD; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female