CORAILRecalls & reported problems across all models
Depuy (Ireland) · 121 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,364
- Deaths reported
- 7
- Injuries reported
- 2,094
- Recalls
- 0
We found 121 models of CORAIL by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 3,364 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2013 and Sep 25, 2026 — classified as 7 deaths, 2,094 injuries, 1,263 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (524 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CORAIL problems
Device problems
- Adverse Event Without Identified Device or Use Problem933
- Device-Device Incompatibility524
- Osseointegration Problem349
- Loss of Osseointegration322
- Appropriate Device Problem Term/Code Not Available187
- Insufficient Device Problem Information146
- Break135
- Naturally Worn134
Patient problems
- Pain922
- No Code Available775
- No Clinical Signs, Symptoms or Conditions668
- Inadequate Osseointegration636
- No Consequences Or Impact To Patient465
- Test Result377
- Unspecified Infection300
- Foreign Body Reaction224
CORAIL models
121 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- CORAIL 9522-11-500BROACH210 reports
- CORAIL 3L92511Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- CORAIL 952210500FBROACH157 reports
- CORAIL 3L92512Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented135 reports
- CORAIL 3L92502Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented126 reports
- CORAIL L20312Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented113 reports
- CORAIL 3L92501Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate108 reports
- CORAIL 3L92510Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented98 reports
- CORAIL 3L92500Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate95 reports
- CORAIL L20412BROACH92 reports
- CORAIL L20411BROACH91 reports
- CORAIL L20311Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate82 reports
- CORAIL 3L92503Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented78 reports
- CORAIL L20313Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate72 reports
- CORAIL 3L92499Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate69 reports
- CORAIL 3L93711Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 death69 reports
- CORAIL 3L92509Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 death67 reports
- CORAIL 3L92507Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented65 reports
- CORAIL L20413BROACH65 reports
- CORAIL 3L93710Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented58 reports
- CORAIL L20431ORTHOPEDIC MANUAL SURGICAL INSTRUMENT58 reports
- CORAIL L20310Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented56 reports
- CORAIL 3L92498Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate55 reports
- CORAIL 3L92513Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate54 reports
- CORAIL 3L93712Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death54 reports
- CORAIL L20410BROACH54 reports
- CORAIL L20409BROACH49 reports
- CORAIL L20314Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 deaths48 reports
- CORAIL L94005ORTHOPEDIC MANUAL SURGICAL INSTRUMENT47 reports
- CORAIL 3L93713Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate45 reports
- CORAIL 3L92514Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 death42 reports
- CORAIL L20414BROACH41 reports
- CORAIL 3L93709Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death38 reports
- CORAIL L20309Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented35 reports
- CORAIL 3L92504Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate34 reports
- CORAIL L94006ORTHOPEDIC MANUAL SURGICAL INSTRUMENT32 reports
- CORAIL L20415BROACH29 reports
- CORAIL 3L92505Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate27 reports
- CORAIL L94007ORTHOPEDIC MANUAL SURGICAL INSTRUMENT27 reports
- CORAIL L20408BROACH24 reports
- CORAIL L94004ORTHOPEDIC MANUAL SURGICAL INSTRUMENT24 reports
- CORAIL L94003ORTHOPEDIC MANUAL SURGICAL INSTRUMENT22 reports
- CORAIL 3L93714Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented21 reports
- CORAIL 3L92515Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate20 reports
- CORAIL 3L93715Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate19 reports
- CORAIL L20315Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented19 reports
- CORAIL L971112Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented18 reports
- CORAIL L20416BROACH16 reports
- CORAIL L20433ORTHOPEDIC MANUAL SURGICAL INSTRUMENT16 reports
- CORAIL L971113Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented16 reports
- CORAIL L971211Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate16 reports
- CORAIL L20432ORTHOPEDIC MANUAL SURGICAL INSTRUMENT15 reports
- CORAIL 3L92516Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate14 reports
- CORAIL 3L92506Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate12 reports
- CORAIL L93205IMPACTOR12 reports
- CORAIL L971110Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate12 reports
- CORAIL L20316Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate11 reports
- CORAIL L20418BROACH10 reports
- CORAIL L98011Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate10 reports
- CORAIL L971111Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented10 reports
- CORAIL L971209Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented10 reports
- CORAIL 3L92518Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate8 reports
- CORAIL L98012Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- CORAIL L98114Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- CORAIL L98116Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- CORAIL L971208Prosthesis, hip, hemi-, femoral, metal7 reports
- CORAIL 3L92508Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- CORAIL 3L93716Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate6 reports
- CORAIL L98015Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- CORAIL L971114Prosthesis, hip, hemi-, femoral, metal6 reports
- CORAIL L971210Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate6 reports
- CORAIL L98013Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- CORAIL L98016Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- CORAIL L971116Prosthesis, hip, hemi-, femoral, metal5 reports
- CORAIL L971308Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- CORAIL L971212Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate5 reports
- CORAIL L98010Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- CORAIL L98014Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- CORAIL L98112Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate4 reports
- CORAIL L98113Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate4 reports
- CORAIL L971313Prosthesis, hip, hemi-, femoral, metal4 reports
- CORAIL L20318Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- CORAIL L20501TRAY, SURGICAL, INSTRUMENT3 reports
- CORAIL L20502TRAY, SURGICAL, INSTRUMENT3 reports
- CORAIL L20503TRAY, SURGICAL, INSTRUMENT3 reports
- CORAIL L98020Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- CORAIL L98115Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- CORAIL L98515TEMPLATE3 reports
- CORAIL L98516TEMPLATE3 reports
- CORAIL L971309Prosthesis, hip, hemi-, femoral, metal3 reports
- CORAIL L971310Prosthesis, hip, hemi-, femoral, metal3 reports
- CORAIL L20106Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- CORAIL L20440TEMPLATE2 reports
- CORAIL L98110Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- CORAIL L98111Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- CORAIL L98120Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- CORAIL L98518TEMPLATE2 reports
- CORAIL L98412XBROACH2 reports
- CORAIL L98413XBROACH2 reports
- CORAIL L981210Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate2 reports
Recent CORAIL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device-Device Incompatibility; Unintended Movement
1 of the 2 brooach handles for Corail was loose. The user tried sz 8/10 up 14/16 broaches and the handle would not hold the broach, therefore it was not usable. The user used the only one that was functional. There was a slight delay. Was there any reported patient or user harm? No
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897214 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that on (b)(6) 2026, the patient underwent revision surgery with the product in question. A patient who had previously underwent implantation of a Corail Revision stem following TFNA removal presented with a distal femoral fracture. As there was also some degree of dislocation, stem replacement was considered. Consequently, revision surgery was performed on the same day and the Corail Revision stem was removed, and the longest Arcos stem and neck component were implanted. The surgery was completed successfully without any delay. No further information is available.This report is related to complaint (b)(4)which captures the revision surgery of the TFNA.
Patient problems: Limb Fracture
MAUDE report 50871421 ↗MalfunctionSep 22, 2026Break
It was reported that prior to an unspecified surgical procedure it was observed that the colored green dot on the STD 135 neck trial device was discovered to be broken prior to surgery. It was reported that half of the colored dot was missing. It was reported that a spare device was available for use. It was reported that there was no delay in the procedure due to the event. It was reported that there was no injury to the patient or user. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852890 ↗InjurySep 10, 2026No Apparent Adverse Event
It was reported that the broach had been introduced into the femoral canal, and an osteotomy of the femur was required at a level below the tip of the broach, however, since the broach was inside the femur, its tip could not be seen from the outside, and when the surgeon used the saw, he ended up scoring the edge of the broach's tip. No patient or user harm and no significant delay were reported.
Patient problems: Bone Notching
MAUDE report 50715639 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568638 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Limb Fracture
MAUDE report 50563793 ↗InjuryAug 18, 2026Osseointegration Problem
It was reported that the pinnacle 62 cup and metal liner were removed because of metalosis. The Corail KS16 stem and ceramic head were also removed because stem was loose.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Unknown.
Patient problems: Foreign Body Reaction; Inadequate Osseointegration
MAUDE report 50305640 ↗MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118112 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to pain. Affected Side: Right.
Patient problems: Pain
MAUDE report 50069193 ↗InjuryJul 10, 2026Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN. AFTER TEST, IT WAS DETERMINED THAT STEM WAS LOOSE, WHICH WAS WHY IT WAS REVISED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 25779122 ↗InjuryJul 1, 2026Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF STEM AND PAIN AT NON CEMENTED INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 25677201 ↗InjuryJun 26, 2026Osseointegration Problem
IT WAS REPORTED THAT PATIENT HAD PRIOR TOTAL HIP SURGERY. PATIENT PRESENTED WITH A LOOSE CORAIL STEM WHICH WAS REMOVED AND REPLACED WITH A COMPETITIVE STEM. THE PINNACLE LINER WAS REMOVED AND REPLACED WITH A DUAL MOBILITY CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 25635095 ↗InjuryJun 25, 2026Osseointegration Problem
IT WAS REPORTED CAME IN WITH A PERI PROSTHETIC FRACTURE FROM A FALL. THE LOOSE CORAIL STEM WAS REMOVED AND REINSERTED WITH RECLAIM MODULAR FOR DISTAL FIXATION TO REGAIN LENGTH FROM THE FRACTURE. DOI-(B)(6) 2017 DOR(B)(6) 2026 AFFECTED SIDE-LEFT HIP.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 25621616 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTS WITH INFECTION POST REVISION THA. POLY AND HEAD HAD BEEN EXCHANGED ON (B)(6) 2021 BUT DER INFORMATION WAS UNAVAILABLE IN OPTIMIZE. RECORDS IN OPTIMIZE ONLY SHOW THE STEM AS THE MIGRATION FROM COMPASS DID NOT TRANSFER THE OTHER IMPLANTS. ALL COMPONENTS WERE REMOVED AND A PROSTALAC SPACER WAS PLACED WITH NO DELAY OR PATIENT HARM NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 25485970 ↗MalfunctionJun 12, 2026Device-Device Incompatibility
IT WAS REPORTED THAT CORAIL STANDARD NECK SEGMENT WOULD NOT MATE TO THE BROACH. BROACH WAS GOOD BUT NECK SEGMENT WAS BAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484465 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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