MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 16; HIP FEMORAL STEM

Catalog Number	L20316
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
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
Revision note reported stem wear.Stem was noted to be well-fixed and not removed.Doi: (b)(6) 2017; (b)(6) 2018; unknown hip.
Additional 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 NON COL HO SIZE 16
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cede 69801 ; FR 69801
• MDR Report Key: 7935533
• Report Number: 1818910-2018-71364
• Device Sequence Number: 1539764
• Product Code: KWL
• UDI-Device Identifier: 10603295258070
• UDI-Public: 10603295258070
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K123991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: L20316
• Device Lot Number: 5269648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 12/12/2018
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 126