iTotal Hip Replacement SystemRecalls & reported problems across all models
Conformis, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 7 models of iTotal Hip Replacement System by Conformis, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Oct 29, 2018 and Jul 10, 2025 — classified as 38 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 iTotal Hip Replacement System problems
Device problems
- Device Dislodged or Dislocated22
- Inadequacy of Device Shape and/or Size6
- Appropriate Device Problem Term/Code Not Available5
- Adverse Event Without Identified Device or Use Problem3
- Wrong Label3
- Break2
- Difficult to Remove2
- Material Deformation2
Patient problems
- No Known Impact Or Consequence To Patient17
- No Code Available9
- Insufficient Information7
- Fall4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Joint Dislocation3
- Bone Fracture(s)2
- Limb Fracture2
iTotal Hip Replacement System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iTotal® Hip Replacement System HBS033000001Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented33 reports
- iTotal® Hip Replacement System HCC032000001Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented10 reports
- iTotal® Hip Replacement System HAA050D00101Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented4 reports
- iTotal® Hip Replacement System HDL060C22S01Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2 reports
- iTotal® Hip Replacement System HAH01032SH01Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented1 report
- iTotal® Hip Replacement System HDL060E32S01Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented1 report
- iTotal® Hip Replacement System HDL060E34S01Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented1 report
Recent iTotal Hip Replacement System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Wrong Label; Wrong Label
THE DEVICE FOR THE CASE WAS INTENDED TO BE A PATIENT-SPECIFIC SIZE 10 CORDERA HIPRX BUT IT INCLUDED THE STEM FOR A PATIENT-SPECIFIC SIZE 14 CORDERA HIPRX. THE PATIENT'S FEMUR SPLIT BECAUSE IT WAS ONLY PREPARED FOR THE SIZE 10 AND HAD TO BE CABLED FOR COMPLETION OF THE PROCEDURE. THIS IS A PATIENT-SPECIFIC CASE AND THE ONLY IMPACTED CASE WAS THE DEVICE DESCRIBED IN THIS REPORT. NO OTHER IMPACTED DEVICES IN THE FIELD.
Patient problems: Limb Fracture; Periprosthetic fracture
MAUDE report 22467708 ↗InjuryJul 2, 2025Wrong Label; Wrong Label
STANDARD ACETABULAR LINER, GROUP C, 36MM WAS INTENDED TO BE USED BUT THE BOX WAS MISLABELED AND THE SURGEON PUT IN A LIPPED, GROUP C, 36MM INSTEAD - HDL-060-C22L-000101. THE SURGEON REMOVED THE CUP AND OPENED A NEW LINER, PLACING A LARGER CUP AND STANDARD LINER CAUSING A DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385172 ↗MalfunctionMar 26, 2025Wrong Label; Wrong Label
DURING A HIP REPLACEMENT PROCEDURE, THE REP OPENED TWO BOXES LABELED AND STANDARD CORDERA HIP LINERS TO DISCOVER THAT BOTH BOXES CONTAINED HOODED LINERS. THE SURGEON HAD TO USE A HOODED LINER TO COMPLETE THE OPERATION INSTEAD OF THE PLANNED STANDARD LINER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21699698 ↗InjuryFeb 26, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT REPLACEMENT CERAMIC AND COCR HEADS HAVE BEEN REQUESTED FOR HIP REVISION SURGERY. REASON FOR REVISION IS INFECTION. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Unspecified Infection
MAUDE report 13611255 ↗InjuryFeb 23, 2022Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SURGEON WASN'T ABLE TO GET A STABLE CONSTRUCT WITH THE PATIENT SPECIFIC STEM COUPLED WITH ANY TRIALED HEAD OFFSET. THE SURGEON ENDED UP REMOVING THE STEM AND IMPLANTING THE SIZE 12 127, 29 STEM. THE SURGEON DIDN'T HAVE A STEM EXTRACTOR AND HE WASN'T HAPPY WITH THE 3D PRINTED TRIAL NECK PERFORMANCE AS IT BENT DURING USE.
Patient problems: Insufficient Information
MAUDE report 13586717 ↗InjuryFeb 2, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DR. CHRIS WILKINSON HAS A PATIENT WHO HAS DISLOCATED A COUPLE OF TIMES AND IS NEEDING TO REVISE HIM. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13429841 ↗InjuryDec 1, 2021Material Deformation
IT WAS REPORTED THAT THE HIP LINER WINGS COMPRESSED DURING INSERTION AND THE POLY INSERT CAME OUT BEFORE THE SURGEON CLOSED. A DIFFERENT POLY INSERT HAD TO BE USED AS A RESULT. THERE WAS A MAJOR DELAY OF ABOUT AN HOUR BECAUSE OF THIS ISSUE.
Patient problems: Insufficient Information
MAUDE report 12913847 ↗InjuryJul 22, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A THA REVISION. THE REASON FOR THE REVISION IS DUE TO DISLOCATION. PRIMARY SURGERY OCCURRED ON (B)(6) 2020. REVISION SURGERY IS PLANNED FOR (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12214978 ↗InjuryJul 2, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A DEPUY CORAIL STEM. THE PATIENT-SPECIFIC STEM WAS NOT ABLE TO GET FULLY SEATED AND SAT ABOUT 6-7MM PROUD WHILE ALSO ADDING ADDITIONAL LEG LENGTH. THE MAIN FACTOR FOR THE REVISION WAS SIGNIFICANT SCOLIOSIS AND PELVIC OBLIQUITY IN THE PATIENT WHICH WASN'T FULLY APPRECIATED BY THE OFFICE X-RAYS, I-VIEW, OR THE SURGEON PREOPERATIVELY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12110222 ↗InjuryJun 17, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION IS PLANNED FOR A PATIENT WITH A POST-OPERATIVE DISLOCATION. IT IS UNKNOWN AT THIS TIME WHAT THE CAUSE FOR THE DISLOCATION WAS.
Patient problems: Joint Dislocation
MAUDE report 12021513 ↗InjuryMay 18, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT SUFFERED A DISLOCATION OF THEIR HIP IMPLANT. REVISION SURGERY OCCURRED ON (B)(6) 2021 WHERE AN EXCHANGE TO DUAL MOBILITY AND HEAD EXCHANGE WERE PERFORMED. THERE WAS NO DAMAGE TO ANY DEVICE DISCOVERED. THE SURGEON BELIEVES THE DISLOCATION WAS RELATED TO A SPINE DEFORMITY THAT THE PATIENT HAS.
Patient problems: Insufficient Information
MAUDE report 11843174 ↗InjuryMay 18, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT SUFFERED A DISLOCATION OF THEIR HIP IMPLANT. REVISION SURGERY OCCURRED ON (B)(6) 2021 WHERE A LINER EXCHANGE AND HEAD EXCHANGE WAS PERFORMED. THERE WERE NO LOOSENING OF COMPONENTS DISCOVERED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11843160 ↗MalfunctionMay 10, 2021Fitting Problem; Positioning Problem
IT WAS REPORTED THAT THE SURGEON HAD TROUBLES WITH THE FIT AND POSITIONING OF THE PATIENT-SPECIFIC STEM. THE SURGEON WAS UNABLE TO FULLY SEAT THE SIZE 13 STEM WHICH SAT 10 MM PROUD. HE COMPLETED THE SURGERY WITH A SMALLER STEM FROM ANOTHER VENDOR WHILE STILL UTILIZING THE CONFORMIS CUP, LINER, AND HEAD.
Patient problems: Insufficient Information
MAUDE report 11802851 ↗MalfunctionApr 14, 2021Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE STEM HUNG UP ABOUT 4 MM PROUD AND THE SURGEON NEEDED AN EXTRACTION INSTRUMENT TO GET THE IMPLANT OUT. THE SURGEON TRAILED WITH SHORTER HEADS, BUT ULTIMATELY STAYED WITH THE PLANNED LENGTH DUE TO OFFSET CONSEQUENCES. THE PATIENT LEG LENGTH WAS LEFT LONGER THAN THE PLAN AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11668014 ↗MalfunctionMar 24, 2021Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE SURGEON WENT TO UTILIZE THE PATIENT-SPECIFIC STEM AND SAID IT WAS TOO SHORT. THE SURGEON USED A STEM FROM A DIFFERENT COMPANY TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 11566261 ↗
Other Conformis, Inc. products
All Conformis, Inc. 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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