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TRANSCEND® 26000020Recalls & reported problems

Microport Orthopedics Inc. · COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER X-LONG NECK · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684260000201), received between Sep 29, 2020 and May 24, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Naturally Worn1

Patient problems

  • Insufficient Information1
  • Metal Related Pathology1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 24, 2022Appropriate Device Problem Term/Code Not Available

    ALLEGEDLY, PATIENT UNDERWENT INDEX SURGERY ON (B)(6) 2015. HOWEVER, PATIENT HAD PAIN AND RECURRENT INSTABILITY AND UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE CUP, SCREWS, LINER, HEAD AND NECK WERE REVISED. THE STEM PHA00606, STEM REVISION "PROFEMUR® Z", LOT: 068501170 WAS NOT REVISED. THIS REVISION SURGERY HAS BEEN CAPTURED UNDER MICROPORT INCIDENT GROUP (B)(4). DURING REVISION SURGERY, PATIENT WAS IMPLANTED WITH A PHAC1252 PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME AND A 26000020 COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER X-LONG FROM WRIGHT MEDICAL. PATIENT RECEIVED ALSO A LINER, INSERT AND ACETABULAR SHELL FROM STRYKER MEDICAL. SINCE HER REVISION ON (B)(6) 2017, PATIENT HAS BEEN COMPLAINING OF ISSUES BUT HAS NOT YET INDICATED WHAT THOSE ISSUES ARE. PATIENT WAS TOLD SHE NEEDED ANOTHER REVISION HOWEVER IT HAS NOT BEEN INDICATED IF IT HAS HAPPENED YET. CHROMIUM LEVEL IS CURRENT 0.2.

    Patient problems: Metal Related Pathology

    MAUDE report 14490294 ↗
  • InjurySep 29, 2020Naturally Worn; Naturally Worn

    ALLEGEDLY, FEMORAL HEAD WORE THROUGH THE POLY LINER . DR (B)(6) LEFT THE HIP STEM AND CUP ALONE. HE CEMENT IN A ZIMMER DUAL MOBILITY LINER AND OUR FEMORAL HEAD.

    Patient problems: Insufficient Information

    MAUDE report 10603034 ↗

Other Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) devices

All Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.