C-Taper Head 06-3205Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327016321), received between Oct 4, 2018 and Nov 1, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Degraded” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K910988, K993601); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ELEVATED COBALT AND CHROMIUM LEVELS. A METAL HEAD WAS REVISED TO A CERAMIC HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Metal Related Pathology

  MAUDE report 18045626 ↗
• InjuryJul 19, 2022Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY TOTAL HIP ARTHROPLASTY WITH SUREFIT STEM AND 32 MM +5 HEAD AND TRIDENT CUP. THE PATIENT LATER PRESENTED WITH A PAINFUL RIGHT HIP AND REQUIRED A REVISION DUE TO POSSIBLE TRUNNIONOSIS AND POSSIBLE PSEUDOTUMOR. INITIAL REPORTER CONFIRMED TRUNNIONOSIS WAS PRESENT & PSEUDOTUMOR WAS SENT TO PATHOLOGY FOR ANALYSIS.

  Patient problems: Cancer; Foreign Body Reaction; Pain

  MAUDE report 15050781 ↗
• InjuryJan 31, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNIONOSIS, GROSS TRUNNION FAILURE, AND DISSOCIATION OF THE HEAD FROM THE STEM. THE STEM, HEAD, AND COMPETITOR LINER WERE REVISED TO COMPETITOR IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 13392142 ↗
• InjuryOct 4, 2018Device Appears to Trigger Rejection; Device Dislodged or Dislocated; Device Appears to Trigger Rejection; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT DISLOCATED HIS PRIMARY IMPLANT DUE TO ASEPTIC LOOSENING CAUSED BY METALLOSIS CREATED FROM THE TRUNNION AND THE HEADBALL. THE HEADBALL EVENTUALLY DISASSOCIATED FROM THE STEM IN VIVO. PATIENT REQUIRED REVISION SURGERY".

  Patient problems: Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 7934370 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K910988, K993601. One submission often covers many models, so check the product and lot details in each record.

• Z-0390-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
• Z-0391-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
• Z-1822-2009 · Jun 18, 2009 · Terminated
  V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended f