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

Catalog Number	L94003
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that 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 being the rubber ring, which holds the trial neck to the femoral broach.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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.

• Brand Name: CORAIL AMT NECK SEG 125D STD
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7872563
• Report Number: 1818910-2018-69275
• Device Sequence Number: 2061920
• Product Code: LZO
• UDI-Device Identifier: 10603295325147
• UDI-Public: 10603295325147
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K142004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L94003
• Device Lot Number: SO2022049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1