Secur-Fit 6054-0913SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327020861), received between Apr 24, 2018 and Jul 2, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "SURGEON STATES PATIENT HAS OSTEOLYSIS IN ACETABULUM AND PROXIMAL FEMUR. PATIENT HAS CERAMIC ON CERAMIC CONSTRUCT IMPLANTED". SPOKE TO REP, WHO PROVIDED THE PRIMARY OPERATIVE AND IMPLANT REPORTS AND PRE-REVISION X-RAYS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Osteolysis

  MAUDE report 8752354 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED DURING PHYSICAL THERAPY. INTRA-OPERATIVELY, NO DEVICES WERE FOUND BROKEN. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM (UNKNOWN HEAD).

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7620078 ↗
• InjuryApr 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A PERIPROSTHETIC FRACTURE AROUND A SECUR-FIT PLUS MAX STEM SIZE 9/13, AND -2.5MM. THE PATIENT WAS CABLED, AND THEN THE FEMUR PREPARED FOR A REPLACEMENT OF IMPLANTS. ORIGINAL SURGERY WAS DONE (B)(6) 2018. SURGEON COMMENTED THAT PATIENT HAD DISCHARGED HIMSELF FROM HOSPITAL EARLY AND WAS NOT COMPLIANT WITH INSTRUCTIONS. THE PATIENT CAME OFF CRUTCHES EARLY. THE SURGEON REPORTED THAT THE PATIENT ¿COULD NOT REMEMBER¿WHAT HAPPENED BEFORE THE FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7455179 ↗

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-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
• 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