MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CORAIL2 NON COL HO SIZE 16; HIP FEMORAL STEM

Catalog Number L20316

Device Problem Corroded (1131)

Patient Problems Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Alleges elevated chromium and cobalt levels in blood and mri results showed necrosis at the left hip joint.It was also alleged that there was loose hip, pain, metallosis, discomfort, injuries, reduced mobility, and emotional distress.After review of medical records for mdr reportability, patient was revised to address failed left metal on metal total metallosis and obesity.Operative notes reported of significant metallosis, pseudocapsular formation, significant trunnionosis/ corrosion, blackening of the trunnion, and extensive black corrosive appearing material behind the metal liner.Laboratory result for metal ions were below 7.Chromium: 1.6 pbb.Cobalt: 3.2 pbb.Doi: (b)(6) 2009; dor: (b)(6) 2015; left hip ((b)(6)).

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.

• Brand Name: CORAIL2 NON COL HO SIZE 16
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7281821
• MDR Text Key: 100403972
• Report Number: 1818910-2018-53683
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295258070
• UDI-Public: 10603295258070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123991
• 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
• Report Date: 01/29/2018

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/22/2011
• Device Catalogue Number: L20316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 11/16/2018
• Date Device Manufactured: 06/22/2006
• 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: 52 YR
• Patient Weight: 159