MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 9; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L93709

Device Problems Loss of Osseointegration (2408); Unintended Movement (3026); Migration (4003)

Patient Problems Adhesion(s) (1695); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/10/2020

Event Type  Injury  

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.

Event Description

Clinical notification received for revision of left total hip to address aseptic loosening and migration of the femoral stem.Date of implantation: (b)(6) 2009, date of revision: (b)(6) 2020, (left hip).Treatment: stem, head, and liner were revised.

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.

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.

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.

Event Description

Revision operative notes 06/10/2020 indicate the patient received a left total hip revision due to pain, with loosening, subsidence and varus angulation of the femoral stem.Upon entering the joint, the femoral stem was noted to be grossly loose.Significant scar tissue and bone was removed from the medial greater trochanter for access.Scar tissue was also noted to be removed from the acetabular side.The surgery was completed without indication of complication by the surgeon.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 9
• Type of Device: 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: 10271730
• MDR Text Key: 198742441
• Report Number: 1818910-2020-15803
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168867
• UDI-Public: 10603295168867
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L93709
• Device Catalogue Number: 3L93709
• Device Lot Number: 2789111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 LAT COXA VARA SIZE 9; DLT TS CER HD 12/14 40MM +5.0; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; CORAIL2 LAT COXA VARA SIZE 9; DLT TS CER HD 12/14 40 MM +5.0; PINNACLE 100 ACET CUP 56 MM; PINNACLE MTL INS NEUT40IDX56OD
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 91