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

Catalog Number	L20316
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/30/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)).
Additional 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
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7281821
• Report Number: 1818910-2018-53683
• Device Sequence Number: 19288629
• Product Code: KWL
• UDI-Device Identifier: 10603295258070
• UDI-Public: 10603295258070
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 06/22/2011
• Device Catalogue Number: L20316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 159