MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 14; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92514

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

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation record received.Patient alleges pain and suffering, serious bodily injuries, and economic loss.Doi: (b)(6) 2010 and (b)(6) 2019, (left hip).

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.

Event Description

Pfs complaints pf severe pain, fatigue, increase pain with activity since (b)(6) of 2018, and also metallosis and elevated levels of cobalt and chromium.After review of medical records, the patient was revised for failed left total hip arthroplasty secondary to wear.Operative notes reported that there were some stained synovial fluid.Doi: (b)(6) 2010.Dor: (b)(6) 2019.Left hip.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 14
• 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; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14073630
• MDR Text Key: 288989514
• Report Number: 1818910-2022-06479
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168805
• UDI-Public: 10603295168805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 3L92514
• Device Catalogue Number: 3L92514
• Device Lot Number: 3163631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/12/2022; 09/28/2022
• Supplement Dates FDA Received: 04/13/2022; 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2010
• 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: 12/14 ARTICUL 40MM M SPEC+8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 115 KG