MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM STD 13; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Catalog Number L98013

Device Problem Malposition of Device (2616)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 03/21/2018

Event Type  Injury  

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 reported incident(s) against the provided product/lot combination(s) 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.

Event Description

Patient was revised to address instability.On (b)(6) 2018: stem had too much version.Doi: (b)(6) 2018; dor: (b)(6) 2018; left hip.

• Brand Name: CORAIL REVISION STEM STD 13
• Type of Device: CORAIL KAR REVISION 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 allée irène joliot curie; bp 256; st priest cedex, rhone-alpes 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; b.p. 256; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7463913
• MDR Text Key: 106582903
• Report Number: 1818910-2018-58271
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295262329
• UDI-Public: 10603295262329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: L98013
• Device Lot Number: 5275992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/26/2018
• Date Device Manufactured: 10/01/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR