MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL REVISION STEM HO 14; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Catalog Number	L98114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
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
Revision of corail stem because of fracture of distal slotted parts.Doi: (b)(6) 2011, (b)(6), dor: (b)(6) 2018; unknown hip.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Device history lot 3015669 device history review 8 products were manufactured and placed into stock on 14 dec 2009.

• Brand Name: CORAIL REVISION STEM HO 14
• Common Device Name: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7446292
• Report Number: 1818910-2018-57877
• Device Sequence Number: 19320017
• Product Code: LWJ
• UDI-Device Identifier: 10603295262428
• UDI-Public: 10603295262428
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2018

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: L98114
• Device Lot Number: 3015669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 04/10/2018; 08/15/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 04/25/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1