MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2019

Event Type  malfunction  

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

Literature article entitled ¿long-term migration characteristics of the corail hydroxyapatite-coated femoral stem: a 14-year radiostereometric analysis follow-up study¿ by owain critchley, et al, published by the archives of orthopaedic and trauma surgery (2020), vol.140, pp.121-127, was reviewed.The purpose of this study was to measure the amount of subsidence for a corail cementless stem implanted in patients with osteoporosis over 14 years using progressive radiostereometric imaging performed at 6 months, 1 year, 2 years, 6 years, and 14 years.The measurements were taken using markers implanted at primary surgery.This complaint will capture the results for 23 patients identified in table 1 on page 124.No implants in the study cohort have been revised.One radiographic image is available in fig 2 on page 123.Results: patient 14: total of 0.486 mm subsidence identified on progressive imaging studies over 14 yrs.No patient consequences or revisions.

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 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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: 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: 10939983
• MDR Text Key: 244917588
• Report Number: 1818910-2020-26064
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1