MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 LAT COXA VARA SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L93713

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Pain (1994)

Event Date 01/16/2023

Event Type  Injury  

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 Description

Patient underwent right corail/pinnacle total hip replacement three years ago.Presented back to gp with complaint of pain.X-ray taken which showed an area of sinus tracking in the bone suspicious of infection.Procedure removal of corail/pinnacle hip replacement, right and insertion of 'kiwi spacer', ie loosely cemented c-stem and marathon cemented cup.Upon removing the corail stem the surgeon stated he could see 'an area of pus' in the femoral canal.Doi: unknown, dor: (b)(6) 2023, right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Through follow up it is now understood there is no allegation associated with this product malfunction.X-ray and photo evidence provided was reviewed and no visible damage was found during the investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

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.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 13
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16252768
• MDR Text Key: 308243745
• Report Number: 1818910-2023-02183
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168904
• UDI-Public: 10603295168904
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 3L93713
• Device Catalogue Number: 3L93713
• Device Lot Number: 5356427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 02/01/2023; 02/07/2023
• Supplement Dates FDA Received: 02/06/2023; 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; CORAIL2 LAT COXA VARA SIZE 13; PINN MAR NEUT 36IDX58OD; PINN SECTOR HA ACET CUP 58MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male