Secur-Fit 6051-0730SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327021011), received between Sep 24, 2018 and Oct 8, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K041170, K051738); 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD A HEMI HIP DONE RECENTLY; PATIENT SUFFERED A PERIPROSTHETIC FRACTURE. DOCTOR REVISED THE HEAD AND STEM TO A REST MOD (WITH LFIT HEAD AND UHR BIPOLAR COMPONENT)." REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED UNITRAX HEAD AND SLEEVE, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 10647855 ↗
• InjuryDec 2, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO STEM SUBSIDENCE. THE STEM, FEMORAL HEAD, AND BIPOLAR COMPONENT WERE REVISED (THERE ARE NO ALLEGATIONS AGAINST THE HEAD OR BIPOLAR COMPONENT). REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9395833 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PATIENT SUSTAINING A FEMORAL PERIPROSTHETIC FRACTURE (CAUSE OF FRACTURE NOT REPORTED TO REP). A SIZE 7 SECURFIT STEM WAS REVISED TO A SIZE 5 OMNIFIT EON STEM WITH 2 CABLE AND SLEEVE SETS AND A DISTAL CEMENT SPACER. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8317937 ↗
• 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 7908190 ↗
• InjurySep 24, 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 DECEMBER 1, 2008 DEBRIDEMENT WAS PERFORMED AND A VAC SYSTEM WAS APPLIED. CULTURE WAS NOTED TO BE POSITIVE FOR METHICILLIN SENSITIVE STAPH AUREUS. WHEN SEEN ON JUNE 3, 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 DECEMBER 8, 2009 REMOVAL OF THE ANTIBIOTIC SPACER AND CONVERSION TO A TOTAL HIP ARTHROPLASTY WAS PERFO

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 7902504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041170, K051738. One submission often covers many models, so check the product and lot details in each record.

• Z-0893-2009 · Nov 13, 2008 · Terminated
  Secur-Fit Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary
• Z-0894-2009 · Nov 13, 2008 · Terminated
  Primary Secur-fit Plus Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular componen