UnitraxRecalls & reported problems across all models
Howmedica Osteonics Corp. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Unitrax model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 3
We found 20 models of Unitrax by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2017 and Sep 9, 2025 — classified as 32 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
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
Unitrax recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 19, 2024Open, Classified
Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Z-2372-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jun 19, 2024Open, Classified
Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Z-2371-2024 · Root cause: Employee error · Recall details · FDA record ↗
- Jun 19, 2024Open, Classified
Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Z-2370-2024 · Root cause: Employee error · Recall details · FDA record ↗
Most reported Unitrax problems
Device problems
- Device Dislodged or Dislocated10
- Adverse Event Without Identified Device or Use Problem8
- Insufficient Device Problem Information7
- Mechanical Problem4
- Fitting Problem2
- Migration2
- Packaging Problem2
- Unstable2
Patient problems
- Injury13
- Unspecified Infection11
- No Consequences Or Impact To Patient10
- Joint Dislocation8
- Bone Fracture(s)3
- Pain3
- No Known Impact Or Consequence To Patient2
- Cancer1
Unitrax models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Unitrax 6942-5-043Prosthesis, hip, hemi-, femoral, metal1 recall4 reports
- Unitrax 6942-5-038Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- Unitrax 6942-5-042Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- Unitrax 6942-5-047Prosthesis, hip, hemi-, femoral, metal7 reports
- Unitrax 6942-7-065Prosthesis, hip, hemi-, femoral, metal6 reports
- Unitrax 6942-5-045Prosthesis, hip, hemi-, femoral, metal4 reports
- Unitrax 6942-5-046Prosthesis, hip, hemi-, femoral, metal3 reports
- Unitrax 6942-5-049Prosthesis, hip, hemi-, femoral, metal3 reports
- Unitrax 6942-7-060Prosthesis, hip, hemi-, femoral, metal2 reports
- Unitrax 6942-7-075Prosthesis, hip, hemi-, femoral, metal2 reports
- Unitrax 6942-5-048Prosthesis, hip, hemi-, femoral, metal2 reports
- Unitrax 6942-5-051Prosthesis, hip, hemi-, femoral, metal2 reports
- Unitrax 6942-6-060Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-6-065Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-6-070Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-5-040Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-5-041Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-5-044Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-5-050Prosthesis, hip, hemi-, femoral, metal1 report
- Unitrax 6942-5-055Prosthesis, hip, hemi-, femoral, metal1 report
Recent Unitrax adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION DUE TO INFECTION - REMOVAL OF HEAD & SLEEVE, WASH OUT.
Patient problems: Unspecified Infection
MAUDE report 23009704 ↗InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED: "PATIENT DISLOCATED HER UNIPOLAR. SHE WAS REVISED TO A RESECTION ARTHROPLASTY WITH NO IMPLANTS (GIRDLESTONE). NO REP PRESENT. NO ALLEGATIONS AGAINST THE IMPLANTS. NO FURTHER INFORMATION WILL BE MADE AVAILABLE." RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22926305 ↗InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISED A HEMI HIP DUE TO DISLOCATION. REVISED THE HEAD AND SLEEVE AND FELT IT WAS POSSIBLE SOFT TISSUE WAS IMPINGING AND CAUSING THE DISLOCATION. HE DECIDED WITH CLINICAL JUDGEMENT TO GO FROM A 55 TO A 53 HEAD AND WITH A STD SLEEVE RATHER THAN -4.
Patient problems: Joint Dislocation
MAUDE report 22580605 ↗InjuryNov 11, 2024Unstable; Unstable
PT. PRESENTED WITH "PAIN AND INSTABILITY" FOLLOWING A RIGHT HEMIARTHROPLASTY ON (B)(6). DR. OPTED TO REVISE THE HEMI BUT UPON CLINICAL ASSESSMENT OF THE HIP INTRA-OP NO ANATOMICAL OR FUNCTIONAL ISSUES COULD BE DETERMINED. DR. OPTED TO REVISE HER UNIPOLAR-CONSTRUCT TO A BIPOLAR-CONSTRUCT. STEM WAS LEFT IN-SITU. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES; NO FURTHER INFO AVAILABLE.
Patient problems: Pain
MAUDE report 20651278 ↗InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PT. PRESENTED WITH A DRAINING SURGICAL WOUND FOLLOWING A RIGHT HEMI DONE "SOME TIME AGO." EXPLANTED ITEMS WERE IDENTIFIED BY VISIBLE-MARKINGS, STEM WAS LEFT IN-SITU." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Wound Dehiscence
MAUDE report 20452841 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INFECTION. A 50MM UNIPOLAR HEAD WAS REVISED TO ANOTHER 50MM UNIPOLAR HEAD PLUS ADJUSTMENT SLEEVE. NO STRYKER REP WAS PRESENT FOR THE PROCEDURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 20342919 ↗InjuryAug 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT IS STATUS POST RIGHT HEMI ARTHROPLASTY REVISION DUE TO MULTIPLE DISLOCATIONS. EXPLANTS INCLUDED UNITRAX HEAD AND V40 SLEEVE. NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY.
Patient problems: Joint Dislocation
MAUDE report 19980273 ↗InjuryJan 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT REVISED, RIGHT SIDE, DUE TO DISLOCATION AND FRACTURE OF THE GREATER TROCHANTER. ALL COMPONENTS WERE REMOVED AND REVISED TO A CEMENTED STEM. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 18491098 ↗InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISED A RIGHT HEMI HIP DUE TO INFECTION. HE REVISED TO A CEMENTED HEMI.
Patient problems: Unspecified Infection
MAUDE report 17387107 ↗InjuryJul 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE UNIPOLAR HEAD FROM THE PATIENT'S NATIVE ACETABULUM. A 47MM UNIPOLAR HEAD AND +0 SLEEVE WERE REVISED TO A 46MM UNIPOLAR HEAD AND +8 SLEEVE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 17367404 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT UNIPOLAR HIP WAS REVISED DUE TO INFECTION. A UNITRAX HEAD AND SLEEVE WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 15705261 ↗InjuryOct 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISED A RIGHT HEMI HIP TO A TOTAL HIP WITH CONSTRAINED LINER DUE TO DISLOCATION. NO ALLEGATIONS AGAINST THE IMPLANTS MADE. UPDATE 30/SEPTEMBER/2022 WG: SPOKE TO REP. REP CONFIRMED THAT THE ENDOPROSTHESIS HEAD CAME OUT OF THE PATIENT'S NATIVE ACETABULUM. REP RE-CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 15648770 ↗InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A UNITRAX HEAD AND SLEEVE WERE REVISED. REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 15459892 ↗InjuryAug 22, 2022Corroded; Corroded
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS CONVERTED FROM A HEMI TO A TOTAL HIP DUE TO THE MODULAR ENDO HEAD MIGRATING THROUGH THE ACETABULUM. INTRA-OPERATIVELY, METAL STAINING WAS NOTED AT THE JUNCTION OF THE STEM AND SLEEVE, AND SOME METAL STAINING IN THE SURROUNDING TISSUE.
Patient problems: Foreign Body Reaction
MAUDE report 15266745 ↗InjuryAug 22, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS CONVERTED FROM A HEMI TO A TOTAL HIP DUE TO THE MODULAR ENDO HEAD MIGRATING THROUGH THE ACETABULUM. INTRA-OPERATIVELY, METAL STAINING WAS NOTED AT THE JUNCTION OF THE STEM AND SLEEVE, AND SOME METAL STAINING IN THE SURROUNDING TISSUE.
Patient problems: Bone Fracture(s)
MAUDE report 15266693 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
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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