MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Unspecified Infection (1930); No Code Available (3191)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision case of an infected corail pinnacle.In speaking with the surgeon before the revision procedure, he advised that the patient had primary thr in february this year and has presented to ed with a dissociated acetabular liner and infected hip.Surgeon unable to say why he thought the patient had a dissociated liner but did mention the patient reporting a fall at some stage.Revised hip to zb-g7 dual mobility cup and c-stem (attachment included with product usage from revision case completed today).Revision surgery went as planned.Explanted products not available as retained by hospital.No further information available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 12
• 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: 10088019
• Report Number: 1818910-2020-12545
• Device Sequence Number: 16856458
• Product Code: KWA
• UDI-Device Identifier: 10603295168898
• UDI-Public: 10603295168898
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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 Model Number: 3L93712
• Device Catalogue Number: 3L93712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/01/2020
• 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: DELTA CER HEAD 12/14 32MM +1; PINN MAR NEUT 50ODX32ID; PINN SECTOR W/GRIPTION 50MM; DELTA CER HEAD 12/14 32MM +1; PINN MAR NEUT 50ODX32ID; PINN SECTOR W/GRIPTION 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR