MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92512

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Mix up of 2 lots of corail stems reported: during a product investigation, the supplier discovered that a product etched with product code 3l92512/ lot 5308136 was found inside a packaging labelled "product code 3l92512/ lot 5307580".

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.

Manufacturer Narrative

(b)(4).The reported event has been evaluated and confirmed.A worldwide recall was initiated for this issue.Depuy considers the investigation closed at this time.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 will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 12
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7510105
• MDR Text Key: 108096727
• Report Number: 1818910-2018-59454
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168782
• UDI-Public: 10603295168782
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3L92512
• Device Lot Number: 5307580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1