MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 14; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92514

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Insufficient Information (4580)

Event Date 12/24/2020

Event Type  Injury  

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 Description

Hcp is reporting a fracture of a corail stem at taper area.Dor: (b)(6) 2020.

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.H10 additional narrative:  added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3, g1, h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device and attached photographs confirmed the reported fracture of the stem.The root cause is attributed to the hip stem being cyclically loaded beyond the material limit.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.Device history lot : a review of the dhr has been completed and no deviations or anomalies were found.

Event Description

Patient received a primary right tha in (b)(6) 2016.The cup, head, and liner were competitor products implanted with a depuy corail stem.Primary operative notes were not provided.Revision 1: patient received a right hip revision of a competitor femoral head to treat pain, limb asymmetry (shortening of the right leg), and mobility limitations of the right hip.Upon entering the joint, the surgeon encounters and excises extensive periarticular ossifications and scarring.The surgeon notes that intraoperative luxation of the joint is difficult due to flexion contracture.The competitor head is removed and replaced with a competitor revision ceramic head with and xl length adapter with 7.50 valgus positioning to treat the reported limb asymmetry.The cup and polyethylene liner are well-positioned and without wear and are retained.Local radiation was also performed as a prophylaxis of periarticular ossifications.The procedure was completed without complications.This procedure was previously unreported.Revision 2: patient received a right hip femoral revision to treat fatigue fracture of the femoral head/neck junction.Upon entering the joint, the surgeon notes dense scarring.The stem is well-fixed and requires an extensive osteotomy to loosen and remove the device in order to revise the broken shaft portion with the competitor femoral head/neck prosthesis.Once the stem is removed, the osteotomy fragments are fixed with cerclage and a screw and cemented competitor products are implanted with a depuy cement plug.The procedure was completed without complications.Doi: (b)(6) 2016 dor: (b)(6) 2017- revision 1 of competitor head dor: (b)(6) 2020- revision 2 of competitor head and corail stem right hip.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 14
• 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: 11146906
• MDR Text Key: 226019225
• Report Number: 1818910-2021-00766
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168805
• UDI-Public: 10603295168805
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92514
• Device Catalogue Number: 3L92514
• Device Lot Number: 5255147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR