MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 10; HIP FEMORAL STEM

Catalog Number 3L93710

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Customer wrote: "i did a microbiological check-up on an implant on (b)(6) 2017 at 07:30.The examination was carried out by first opening the box, then hand disinfecting of the staff´s hand and then taking the sample.The result shocks me, as the sampling aerobic spore formers shows turf growth 16 - 50 cfu.As you can read in the literature, a disinfection of the outer packaging is without effect." customer is asking for a statement.Customer does not remember ref/lot; a list of possible samples is attached.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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 LAT COXA VARA SIZE 10
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st anthonys road; bp 256; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7227124
• MDR Text Key: 98559147
• Report Number: 1818910-2018-52307
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295168874
• UDI-Public: 10603295168874
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3L93710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1