MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 18; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L93718

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the implants were removed due to infection.Doi: (b)(6) 2020 (cup and stem), (b)(6) 2020 (liner and head), dor: (b)(6) 2020, affected side: 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.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 18
• 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
• MDR Report Key: 11154019
• MDR Text Key: 226245834
• Report Number: 1818910-2021-00864
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295168942
• UDI-Public: 10603295168942
• Combination Product (y/n): N
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3L93718
• Device Catalogue Number: 3L93718
• Device Lot Number: 5332405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM +8.5; PINN SECTOR W/GRIPTION 56MM; ALTRX +4 NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM +8.5; PINN SECTOR W/GRIPTION 56MM
• Patient Outcome(s): Required Intervention