MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L93711

Device Problems Loss of Osseointegration (2408); Unintended Movement (3026); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/04/2020

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 patient had a total hip on (b)(6) 2019.The doctor thinks he undersized the stem because it counter sunk.So the patient is having hip revision surgery to put in a longer and bigger stem.Doi: (b)(6) 2019; dor: (b)(6) 2020; right side.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The attached x-ray image is unable to confirm to reported allegation.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.H10 additional narrative: corrected: h6 (device code).The previous reported device code unintended movement is being corrected to appropriate coding which is migration.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 11
• 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: 10160939
• MDR Text Key: 195367168
• Report Number: 1818910-2020-13936
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168881
• UDI-Public: 10603295168881
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L93711
• Device Catalogue Number: 3L93711
• Device Lot Number: 5332801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 LAT COXA VARA SIZE 11; DLT TS CER HD 12/14 40MM +8.5; CORAIL2 LAT COXA VARA SIZE 11; DLT TS CER HD 12/14 40MM +8.5
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR