Unitrax 6942-5-043Recalls & reported problems
Howmedica Osteonics Corp. · Head Component · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327032376), received between Apr 16, 2019 and Oct 15, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
1 FDA recall record name this device's identifier, 1 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, 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
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
Patient problems
- Injury2
- Pain1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjurySep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "PATIENT PRESENTED TO CLINIC WITH RIGHT HIP PAIN. DECISION WAS MADE TO REVISE MONOPOLAR TO TOTAL HIP. STEM NOT REVISED. NO DAMAGE VISUALIZED WITH EXPLANTS. EXPLANT NOT AVAILABLE SECONDARY TO PATIENTS REQUEST FOR IMPLANT. PATIENT FROM OUT OF STATE - NO PREVIOUS OPERATIVE REPORT AVAILABLE." REP PROVIDED A PRE-REVISION X-RAY AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Injury; Pain
MAUDE report 9079687 ↗InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED BY REP: "HIP TOTAL ARTHROPLASTY REVISION - RIGHT. RIGHT HIP REVISION¿WITH ABDUCTOR REPAIR. PRE OP DIAGNOSIS: RIGHT HIP DEGENERATIVE JOINT DISEASE". A UNITRAX HEAD AND +0 SLEEVE WERE REVISED. REP CONFIRMED THE SIZE 6 ACCOLADE II STEM WAS NOT REVISED, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. (B)(6) 2019: AS PER PHONE CALL WITH THE SALES REP, THE PATIENT WAS CONVERTED TO A TOTAL HIP TO ADD ACETABULAR COMPONENTS DUE TO PROGRESSION OF THE PATIENT'S DEGENERATIVE JOINT DISEASE. THERE WAS NO ISSUES NOTED WITH THE EXPLANTED DEVICES DURING THE REVISION SURGERY. IT IS UNKNOWN AS TO WHY THE PATIENT'S ABDUCTOR NEEDED REPAIR.
Patient problems: Injury
MAUDE report 8517935 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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