MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT NECK SEG 135D KHO; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	L94006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
After removal of o-ring as per fsca corail - pie-1125109 the trial neck and the trial stem are disassembling/separating without any forces.This did not happen intraoperatively, no adverse consequences for anybody.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: no device was returned 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 135D KHO
• 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: 7663852
• Report Number: 1818910-2018-63815
• Device Sequence Number: 1524198
• Product Code: LXH
• UDI-Device Identifier: 10603295325178
• UDI-Public: 10603295325178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L94006
• Device Lot Number: NB99156
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1