MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 12

Catalog Number L20312

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

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

Asr litigation records received.Litigation alleges pain, stiffness, discomfort, locking and weakness.Patient suffers from anxiety, limited mobility, metal toxicity and emotional distress.Patient has not yet scheduled an explantation of the asr hip implant.Doi: (b)(6) 2008 : dor: not revised; (left hip).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: CORAIL2 NON COL HO SIZE 12
• Type of Device: CORAIL
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; b.p. 256; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7560630
• MDR Text Key: 109780420
• Report Number: 1818910-2018-61137
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L20312
• Device Lot Number: 2367078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/06/2018; 09/28/2018
• Supplement Dates FDA Received: 06/08/2018; 10/01/2018
• Date Device Manufactured: 05/04/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1