iTotal® Hip Replacement System HBS033000001Recalls & reported problems
Conformis, Inc. · HIP-PATIENT SPECIFIC STEM LEFT · Class 2 · Implant
All models of iTotal Hip Replacement System (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Conformis iTotal hip replacement stem is a patient-specific metal hip implant made to match an individual patient's anatomy. The 33 reports mostly describe the stem coming loose or dislocating after surgery, along with sizing and fit issues; 26 reports involved injuries and no deaths were reported. Some describe the stem not seating fully or a trial neck bending during surgery, leading to revision operations. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI M572HBS0330000011), received between Nov 21, 2018 and Jul 10, 2025 — classified as 26 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 reports).
4 other recalls cover devices cleared under the same FDA submission (K162719); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated16
- Inadequacy of Device Shape and/or Size5
- Appropriate Device Problem Term/Code Not Available4
- Adverse Event Without Identified Device or Use Problem2
- Crack1
- Device Markings/Labelling Problem1
- Fitting Problem1
- Loose or Intermittent Connection1
Patient problems
- No Known Impact Or Consequence To Patient10
- Insufficient Information6
- No Code Available5
- Joint Dislocation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fall2
- Limb Fracture2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 33 reports, 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 ↗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 ↗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 ↗InjurySep 24, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT FELL IN THE SHOWER AND BROKE THEIR FEMUR. AS A RESULT, THE FEMORAL STEM IS LOOSE. REVISION SURGERY IS PLANNED TO ADDRESS THE ISSUE.
Patient problems: Fall; Limb Fracture
MAUDE report 10583810 ↗MalfunctionAug 25, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE HIP DISLOCATION SHORTLY AFTER THEIR PRIMARY SURGERY. THE SURGEON SUCCESSFULLY CORRECTED THE ISSUE VIA A CLOSED REDUCTION. THE SURGEON BELIEVES THE ANESTHESIA LASTED LONGER THAN USUAL FROM THE PRIMARY SURGERY AND CAUSED THE PATIENT TO STEP INCORRECTLY, CAUSING THE DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10450899 ↗InjuryJul 23, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE HIP DISLOCATION. THE PATIENT RECEIVED A CLOSED REDUCTION TO ADDRESS THE ISSUE.
Patient problems: No Code Available
MAUDE report 10317862 ↗InjuryJul 15, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE HIP DISLOCATION. THE PATIENT RECEIVED A CLOSED REDUCTION TO ADDRESS THE ISSUE.
Patient problems: No Code Available
MAUDE report 10280087 ↗MalfunctionJun 30, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT WENT TO THE ER WITH RIGHT HIP PAIN AFTER SHE FELT A POP. AN ORTHO DISLOCATION REDUCTION PROCEDURE WAS PERFORMED UNDER SEDATION AND THE PATIENT WAS DISCHARGED WITH A KNEE IMMOBILIZER.
Patient problems: Pain
MAUDE report 10215459 ↗InjuryMay 15, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS A HIP DISLOCATION. REPLACEMENT COMPONENTS HAVE BEEN ORDERED FOR REVISION SURGERY.
Patient problems: Joint Dislocation
MAUDE report 10063332 ↗InjuryApr 21, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A FALL RESULTING IN A HIP DISLOCATION. LINERS AND HEADS HAVE BEEN ORDERED FOR REVISION SURGERY.
Patient problems: Fall
MAUDE report 9982611 ↗InjuryApr 8, 2020Crack
IT WAS REPORTED THAT THE PATIENT'S GREATER TROCHANTER WAS CRACKED DURING A TOTAL HIP ARTHROPLASTY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9935391 ↗InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE END OF SURGERY, A CALCAR CRACK WAS NOTICED IN THE PATIENT. THE SURGEON UTILIZED A CABLE TO STABILIZE THE CRACK AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 9742043 ↗InjuryJan 28, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAS A POST-OPERATIVE HIP DISLOCATION. REVISION SURGERY IS PLANNED TO EXCHANGE THE LINER AND HEAD.
Patient problems: No Code Available
MAUDE report 9638017 ↗InjuryJan 8, 2020Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PLANNED STEM SIZE FOR THE PATIENT WAS TOO LARGE TO ACCOMMODATE THE FEMORAL CANAL. THE SURGEON MADE A CONVERSION TO AN OFF-THE-SHELF HIP REPLACEMENT AND COMPLETED THE SURGERY SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9565682 ↗InjuryJan 3, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT A HIP PATIENT HAS A POST-OPERATIVE DISLOCATION. REPLACEMENT COMPONENTS HAVE BEEN ORDERED FOR REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9546354 ↗InjuryNov 27, 2019Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE CONFORMIS CUSTOM STEM DID NOT FIT PROPERLY DURING SURGERY. THE SURGEON HAD TO MAKE AN INTRAOPERATIVE CONVERSION TO AN OFF-THE-SHELF STEM TO COMPLETE THE PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 9385568 ↗InjuryNov 15, 2019Malposition of Device
IT WAS REPORTED THAT THE SURGEON CONVERTED FROM A CONFORMIS CUSTOM STEM AND HEAD TO AN OFF-THE-SHELF STEM AND HEAD. THE CONFORMIS STEM CCD ANGLE OF 125 WAS TOO VARUS AND CREATED TOO MUCH OFFSET WITH THE XL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9329194 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162719. One submission often covers many models, so check the product and lot details in each record.
- Z-0063-2020 · Aug 22, 2019 · TerminatediTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- Z-0064-2020 · Aug 22, 2019 · TerminatediTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
- Z-1775-2019 · Mar 29, 2019 · TerminatedConformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
- Z-0731-2019 · Oct 16, 2018 · TerminatediTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Other Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented devices
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
- Vivacit-E® 110031012Zimmer, Inc. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall33 reports
- G7® Dual Mobility Acetabular System 110024462Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall22 reports
- DJO SURGICAL 942-01-36HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall5 reports
- DJO SURGICAL 942-01-36JEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall1 report
- DJO SURGICAL 942-01-32CEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall0 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145150Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented46 reports
- TAPERLOC COMPLETE MICRO PRIMARY FEMORAL 51-106160Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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