C-Taper Head S-1400-HH34Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327016734), received between Sep 21, 2018 and Oct 5, 2018 — classified as 3 injuries.

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

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2018Degraded; Degraded

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO ELEVATED COBALT AND CHROMIUM LEVELS AFTER PATIENT COMPLAINT OF SEVERE PAIN SINCE 2013. INTRA-OPERATIVELY, TRUNNIONOSIS WAS NOTED. THE HEAD AND LINER WERE EXCHANGED FOR A 36E LINER AND SIZE 36 CERAMIC HEAD WITH A +5 ADAPTER SLEEVE - STEM WAS CLEANED OFF AND RETAINED.

  Patient problems: Injury; Pain; Reaction

  MAUDE report 7937986 ↗
• InjurySep 25, 2018Degraded; Degraded

  "ON (B)(6), 2008 AN EXPLORATION INCISION AND DRAINAGE OF THE RIGHT HIP AND THIGH WAS PERFORMED FOR A DIAGNOSIS OF METALLOSIS RIGHT HIP AND INTRAPELVIC FLUID."

  Patient problems: Edema; Inflammation; Injury; Reaction

  MAUDE report 7906345 ↗
• InjurySep 21, 2018Material Deformation; Material Deformation

  REVIEW OF THE MEDICAL REVIEW INDICATED, "ON (B)(6) 2008 AN EXPLORATION OF THE RIGHT TOTAL HIP, INCISION AND DRAINAGE, AND VAC DRESSING APPLICATION WAS PERFORMED FOR A POST-OPERATIVE DIAGNOSIS OF EXTENSIVE METALLOSIS RIGHT HIP. THE OPERATIVE REPORT DESCRIBES A LATERAL APPROACH AND FINDINGS INCLUDING METALLOSIS OF THE RIGHT HIP AND THIGH WITH DAMAGE AND WEAR TO THE POLY LINER AND HEAD. EXTENSIVE METALLOSIS AROUND THE PROXIMAL FEMORAL COMPONENT AND BEHIND THE ACETABULAR COMPONENT WAS NOTED AND THE SURGEON DID NOT CLOSE THE FASCIA AND KEPT A SPONGE IN THE PROXIMAL FEMUR AND ACETABULUM AFTER EXPLANTING THE TOTAL HIP COMPONENTS. ON (B)(6) 2008 DEBRIDEMENT WAS PERFORMED AND A VAC SYSTEM WAS APPLIED. CULTURE WAS NOTED TO BE POSITIVE FOR METHICILLIN SENSITIVE STAPH AUREUS. WHEN SEEN ON (B)(6) 2009 SHE WAS NOTED TO BE 6-CENTIMETERS SHORT ON THE RIGHT LOWER EXTREMITY." "ON (B)(6) 2009 A RIGHT HIP WOUND REVISION WITH INCISION AND DRAINAGE AND INSERTION OF AN ANTIBIOTIC SPACER WAS PERFORMED FOR AN INFECTED GIRDLESTONE WITH CHRONIC OSTEOMYELITIS AND PARTICLE DISEASE OF THE RIGHT HIP." "ON (B)(6) 2009 REMOVAL OF THE ANTIBIOTIC SPACER AND CONVERSION TO A TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR A

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 7897736 ↗