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

Model Number 3L92511

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

The customer reports that during the procedure, after preparing the femur , the corresponding sized 11 of the device is placed but cannot be fully impacted.The device was blocked at the three quarters.The device looks like at the size 12.The customer thinks that the length of the femoral rod did not match the length of the marked on the box.The femoral rod was removed and replaced by another one.There was a surgery delay.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. .

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: the device was reviewed and met specification.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD 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: 9417706
• MDR Text Key: 169293408
• Report Number: 1818910-2019-120889
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168775
• UDI-Public: 10603295168775
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 3L92511
• Device Catalogue Number: 3L92511
• Device Lot Number: 5345214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 01/27/2020
• Supplement Dates FDA Received: 12/16/2019; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR