MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Catalog Number	L20310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The primary surgery was performed on (b)(6) 2019 via tha.It was reported that the removal surgery was performed on (b)(6) , 2019 by explanting the stem (p/n: l20310), the head (p/n: 136532330) due to postoperative infection.The surgery was completed within a 30 minutes surgical delay.No further information is available.
Additional Manufacturer Narrative
This is a duplicate report of 1818910-2019-102853.1818910-2019-104141 is being retracted as it is a report duplication.1818910-2019-102853 will be kept for investigation.

• Brand Name: CORAIL2 NON COL HO SIZE 10
• Common Device Name: 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: 9008448
• Report Number: 1818910-2019-104141
• Device Sequence Number: 11395170
• Product Code: KWA
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Catalogue Number: L20310
• Device Lot Number: 5230497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention