MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 6; CORAIL AMT CEMENTLESS IMPLANT : HIP IMPLANTS

Catalog Number	L20106
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Hip revision - (b)(6) hospital (b)(6) 2018.Primary implant date: (b)(6) 2017.Reason for revision: pain, bone scan indicates implant loose.Patient fell 6 months following surgery, patient developed pain immediate post fall.Infection was ruled out as cause of pain followed by bone scan 6 months post fall.Surgeon felt stem was loose and was removed.Replaced with a cemented stem and new head acetabular components were left institute.Patient activity levels - moderate activity still walking with aid of a walking stick.Female patient initials (b)(6).Doi: (b)(6) 2017; dor: (b)(6) 2018; unknown hip.
Additional Manufacturer Narrative
(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, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 6
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP IMPLANTS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7439717
• Report Number: 1818910-2018-57643
• Device Sequence Number: 11035897
• Product Code: KWL
• UDI-Device Identifier: 10603295257998
• UDI-Public: 10603295257998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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 Catalogue Number: L20106
• Device Lot Number: 5218143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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: 38 YR
• Patient Weight: 118