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

Catalog Number L98114

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Osseointegration (2646); Not Applicable (3189)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision of corail stem because of fracture of distal slotted parts.Doi: (b)(6) 2011, (b)(6), dor: (b)(6) 2018; unknown hip.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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
• Type of Device: 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
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7446292
• MDR Text Key: 106019499
• Report Number: 1818910-2018-57877
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295262428
• UDI-Public: 10603295262428
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093736
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: L98114
• Device Lot Number: 3015669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 08/15/2018
• Supplement Dates FDA Received: 04/25/2018; 08/15/2018
• Date Device Manufactured: 12/15/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1