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

Catalog Number 3L92511

Device Problem Corroded (1131)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/26/2018

Event Type  Injury  

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

Reason for revision: pitting corrosion.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Device history lot: 5009973 device history review: initial conformance of the 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, a follow-up medwatch will be filed as appropriate.

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.

• Brand Name: CORAIL2 STD SIZE 11
• 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
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8185744
• MDR Text Key: 131048274
• Report Number: 1818910-2018-78895
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295168775
• UDI-Public: 10603295168775
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3L92511
• Device Lot Number: 5009973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention