MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 13; HIP FEMORAL STEM

Model Number	L20313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	11/18/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.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.
Event or Problem Description
Asr revision.Asr unknown; unknown hip.Reason for revision: claim letter alleges patient was revised due to high chromium and cobalt metal particles in the blood and metallosis.The patient is seeking compensation for all the damages suffered.Doi: (b)(6) 2008 - dor: (b)(6) 2010 (unknown hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.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.
Event or Problem Description
Litigation alleges unbearable pains, squeaking noise from prosthetic joint, powerlessness, discomfort, elevated metal ions in the blood and metallosis.The malfunction of the mom prosthesis resulted to higher friction with increased toxic ions.Doi: (b)(6) 2008, dor: (b)(6) 2010, right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL2 NON COL HO SIZE 13
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10361853
• Report Number: 1818910-2020-17446
• Device Sequence Number: 951170
• Product Code: KWA
• UDI-Device Identifier: 10603295258049
• UDI-Public: 10603295258049
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2010
• Device Model Number: L20313
• Device Catalogue Number: L20313
• Device Lot Number: 1900322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 02/10/2021
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 01/29/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASR ACETABULAR IMPLANT 52; DEPUY ASR XL FEM IMP SIZE 46; LARGE MOD HEAD ADAPT 12/14 +5; ASR ACETABULAR IMPLANT 52; DEPUY ASR XL FEM IMP SIZE 46; LARGE MOD HEAD ADAPT 12/14 +5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR