CORAIL L981209Recalls & reported problems

Depuy (Ireland) · CORAIL HIP SYSTEM CEMENTLESS FEMORAL STEM HA COATED 12/14 AMT 125 DEGREES STANDARD NO COLLAR SIZE 9 · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295446873), received between Jul 16, 2024 and Jul 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Tear, Rip or Hole in Device Packaging1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE CUSTOMER RECEIVED WET IMPLANTS. MULTIPLE PRODUCTS ARE DAMAGED. THE CASE WAS PUSHED TO TODAY FROM LAST THURSDAY.
Patient problems: Insufficient Information
MAUDE report 19750147 ↗

Device details

UDI-DI	`10603295446873`
Brand	CORAIL
Model	L981209
Company	Depuy (Ireland)
Product code	MEH · Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Class	Class 2
FDA submission	K173960, K190344, K192946
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 9, 2025

Device type (GMDN): Coated femoral stem prosthesis, one-piece

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Other Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate devices

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Novation 130-36-53
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Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
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Novation 130-32-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
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Novation 132-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls26 reports
Novation 136-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls22 reports

All Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.