MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/05/2018

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

"literature article abstract entitled, ¿femoral stem subsidence in cementless total hip arthroplasty:a retrospective single-centre study¿ by christian ries, et al; published by international orthopaedics (2019), vol.43, pp.307-314, was reviewed.The purpose of this study was to analyze the prosthetic and anatomic risk factors for femoral stem subsidence in 231 corail stems implanted between august 2009 and december 2010.The authors utilized serial radiographic studies in 199 collarless and 32 collared stems.Results: 223 stems showed some evidence of subsidence on serial radiographic studies.There were no reported patient consequences or treatments reported.No revisions were performed in the follow-up study.Radiographic images are available on page 308 fig.2, pp.309 fig.3, and pp.310 fig.4.Case 2 table 2: female aged (b)(6) experienced a periprosthetic femoral fracture during implantation of a collarless corail stem, treated with cerclage.3.1 mm of stem subsidence was identified in serial radiographic studies at 12 months.No treatment or patient consequences reported for the migration of the stem.

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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10930941
• MDR Text Key: 219127430
• Report Number: 1818910-2020-25889
• 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: 11/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• 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: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR