MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 16; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	06/08/2011
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).
Event or Problem Description
Patient was revised to address a malpositioned metal liner and leg length discrepancy.Osteolysis was also reported.Litigation alleges that the patient suffers from pain, swelling, inflammation, infection, and damage to surrounding bone and tissue, dislocation, and lack of mobility.Ppf alleged elevated metal ions.Doi: (b)(6) 2007; dor: (b)(6) 2011 (right hip).
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.Device history lot: 1862361.Device history batch: null.Device history review: a device history record (dhr) review was conducted previously on (b)(4).The dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.

• Brand Name: CORAIL2 STD SIZE 16
• 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: 8211888
• Report Number: 1818910-2019-79681
• Device Sequence Number: 1987961
• Product Code: KWA
• UDI-Device Identifier: 10603295168829
• UDI-Public: 10603295168829
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2010
• Device Catalogue Number: 3L92516
• Device Lot Number: 1862361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: 74 YR
• Patient Weight: 91