MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> 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 will be filed as appropriate.

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation papers allege the patient suffered extreme pain, discomfort, soreness, malaise, swelling, loss of energy, immobilization, both acute localized damage to tissue and/or bone surrounding the acetabulum and systemic injuries.Papers also allege excessive levels of chromium and cobalt blood levels.Doi: (b)(6) 2009, dor: none scheduled at this time (left side); doi: (b)(6) 2009, dor: none scheduled at this time (right side); doi: (b)(6) 2009, dor: none reported (left hip).See bilateral: (b)(4) right hip.

• Brand Name: CORAIL2 STD SIZE 15
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9469058
• MDR Text Key: 185396144
• Report Number: 1818910-2019-123118
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295168812
• UDI-Public: 10603295168812
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3L92515
• Device Lot Number: 2583759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2008
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR