MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92515
Medical Device Problem Codes	Loss of Osseointegration (2408); Biocompatibility (2886); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
Date of Event	03/01/2012
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.(b)(4).Initial reporter is an attorney.
Event or Problem Description
Litigation alleges patient suffers from severe pain, discomfort, and inflammation.Litigation also alleges large amounts of toxic cobalt-chromium metal ions and particles to be released into the plaintiff's blood, tissue, and bone.Update: 7/3/2013 pfs was received from legal, medical records were received from legal, and part/lot information was identified by invoice search.Update ad 20 jun 2018 receipt of ppf and sticker sheets record.In addition to previous allegations, ppf alleges loosening of stem and metallosis.
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 STD SIZE 15
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : 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: 8338693
• Report Number: 1818910-2019-84492
• Device Sequence Number: 2253285
• Product Code: KWA
• UDI-Device Identifier: 10603295168812
• UDI-Public: 10603295168812
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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 Catalogue Number: 3L92515
• Device Lot Number: 1859910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: 48 YR