MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92510

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problem No Code Available (3191)

Event Date 08/28/2020

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

Revision of a femoral stem that broken inside the patient.The primary surgery was in 2012.

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.The concomitant product was identified to be a competitor product used in conjunction with the previously reported adverse event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received stated that the affected side is the left side.Surgery time was not extended.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the attached x-ray image confirmed the reported allegation.The root cause could not be determined.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.Device history lot : lot 3453095.Dhr has been reviewed and no deviations or anomalies were found.

• Brand Name: CORAIL2 STD SIZE 10
• 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: 10540810
• MDR Text Key: 207145977
• Report Number: 1818910-2020-20202
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168768
• UDI-Public: 10603295168768
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92510
• Device Catalogue Number: 3L92510
• Device Lot Number: 3453095
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR HEAD
• Patient Outcome(s): Required Intervention
• Patient Weight: 100