MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 14; HIP FEMORAL STEM/SLEEVE

Catalog Number 3L92514

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Burning Sensation (2146); Discomfort (2330); No Code Available (3191)

Event Date 03/04/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation received.Litigation alleges pain and general litigation notes metal on metal implications.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

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.

Event Description

Update jun 01, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges discomfort, burning sensation.On (b)(6) 2015, patient was detected to have elevated metal levels.After review of medical records, there is no new information that changes existing mdr reportability.No lab reports received for the alleged elevated metal levels.Part and lot information were provided.This complaint was updated on: jun 12, 2017.

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.

Event Description

In addition to the previous allegations, ppf alleges pseudotumor, metal wear and metallosis.Doi: (b)(6)2006 - dor: (b)(6)2015 (right hip).

• Brand Name: CORAIL2 STD SIZE 14
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 6252841
• MDR Text Key: 64884254
• Report Number: 1818910-2017-10891
• 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: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2016

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: 3L92514
• Device Lot Number: 1992351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/15/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/11/2018; 01/04/2019
• Supplement Dates FDA Received: 02/08/2017; 06/19/2017; 09/27/2018; 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2005
• 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: 56 YR
• Patient Weight: 86