MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT NECK SEG 125D KLA; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number L94004

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the complaint was deemed as justified.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The rubber ring and area behind the rubber ring in each trial neck contains dried blood when removed.This is unsterile and presents a sterility risk.The cssd department will not re-sterilise the trial necks without the rubber ring unless provided written approval from j&j to do this.All corail trial necks were examined at the hospital and all were found to have dried blood in the area behind the rubber ring, which holds the trial neck to the femoral broach.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the complaint was deemed as justified.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.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. .

• Brand Name: CORAIL AMT NECK SEG 125D KLA
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0998 ; 5743725905
• MDR Report Key: 7872689
• MDR Text Key: 120246846
• Report Number: 1818910-2018-69289
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295325154
• UDI-Public: 10603295325154
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K142004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L94004
• Device Lot Number: NB110946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1