MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 15; HIP FEMORAL STEM

Catalog Number	L20315
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	02/22/2019
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
Subject id: (b)(6).Clinical adverse event received for periprosthetic femur fracture.Event is serious and is considered severe.Event is definitely related to device and definitely not related to procedure.Doi: (b)(6) 2019; doe: (b)(6) 2019; (right hip).Treatment includes orif.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 NON COL HO SIZE 15
• 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: 8425860
• Report Number: 1818910-2019-87472
• Device Sequence Number: 16686981
• Product Code: KWA
• UDI-Device Identifier: 10603295258063
• UDI-Public: 10603295258063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: L20315
• Device Lot Number: 5322266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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
• Patient Age: 84 YR
• Patient Weight: 86