MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 9; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92509

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Death (1802); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Not Applicable (3189)

Event Date 02/28/2017

Event Type  Death  

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

Complaint description: patient was revised due to pain and instability.(b)(4) is a reopen of (b)(4) due to receipt of the following information: update apr 17, 2018: pinnacle litigation received.Litigation alleges increasing pain, discomfort, tenderness in the right hip, mental anguish, physical and emotional injury.Patient also experienced stiffness, decreased range of motion, difficulty rotating the hip joint, difficulty weight bearing, difficulty ambulating, elevated metal levels and subsequently died on (b)(6) 2017.Doi: (b)(6) 2009 : dor: (b)(6) 2017 (right hip).Date of death: (b)(6) 2017.

Manufacturer Narrative

(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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges infection, metal wear and metallosis.

• Brand Name: CORAIL2 STD SIZE 9
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; b.p. 256; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 7506650
• MDR Text Key: 107990706
• Report Number: 1818910-2018-59389
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168751
• UDI-Public: 10603295168751
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3L92509
• Device Lot Number: 2631650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Date Device Manufactured: 10/16/2008
• 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): Death
• Patient Age: 64 YR