MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 13; HIP FEMORAL STEM/SLEEVE

Catalog Number 3L92513

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Fitting Problem (2183)

Patient Problems Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Information (3190); No Code Available (3191)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Patient was revised to address subsidence.

Manufacturer Narrative

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).

Event Description

Pinnacle litigation record received.Litigation alleges discomfort, pain, stiffness and loss of motion.It was also stated that the patient is at risk for metal toxicity due to elevated cobalt and chromium metal ions, implant loosening, metallosis, necrosis, soft tissue damage, muscle damage and injury.

Event Description

In addition to what were previously alleged, pfs alleges right leg weakness and difficulty in going up and down the stairs.After the review of medical records, it was reported that the patient was revised to address loosening of the femoral stem.Revision notes reported subsidence and some movement of the stem due to incorrect fit.Removed metal poisoning and metallosis since they were not indicated in the revision notes.Voided liner since it was not revised.Voided previously reported unknown hip implant since it was confirmed that stem had loose and subsided.There is no lab results provided.

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.

• Brand Name: CORAIL2 STD SIZE 13
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 6622972
• MDR Text Key: 77011629
• Report Number: 1818910-2017-19171
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/10/2017

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 3L92513
• Device Lot Number: 5232744
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 07/05/2017; 01/22/2018; 02/20/2018; 02/17/2021
• Supplement Dates FDA Received: 07/06/2017; 01/26/2018; 02/27/2018; 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 98