MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 STD SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92507
Medical Device Problem Codes	Use of Device Problem (1670); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
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 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 that on (b)(6) 2016, the patient underwent the total hip arthroplasty with the stem and the liner for the osteoarthritis of the right hip joint.The surgery was completed successfully without any surgical delay.Two years after the surgery, although the stem started to sink, the patient did not complain of pain.The surgeon was following up the patient.In 2022, the patient complained of pain, and the stem was sunk and was retro-twisting.Therefore, the revision surgery was performed on (b)(6) 2022.The stem was loosened, and the liner was not locked to the cup.The part of the liner was floating.The stem was replaced with other company¿s stem, and the liner was replaced with a new liner.According to the surgeon, the stem seemed to be slightly small.The stem was collar-less, so that the surgeon commented that he should have chosen one size larger stem for fixation.The stem began to retro-twist with sinking.Since the liner was not broken and deformed, the liner was most likely not correctly locked at the primary surgery.No further information is available.
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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This medwatch report was initially submitted on 9/22/2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket (b)(4) for additional details.

• Brand Name: CORAIL2 STD SIZE 8
• 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 INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15393877
• Report Number: 1818910-2022-17560
• Device Sequence Number: 12293104
• Product Code: LZO
• UDI-Device Identifier: 10603295168737
• UDI-Public: 10603295168737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 3L92507
• Device Catalogue Number: 3L92507
• Device Lot Number: 5242268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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: CORAIL2 STD SIZE 8; PINN MAR ETO NEUT 32IDX50OD; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown