Secur-Fit 6052-0625SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327021097), received between Dec 22, 2017 and Nov 18, 2022 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryNov 18, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLETED 6-YEAR FOLLOW-UP QUESTIONNAIRE FOR THE RESTORATION ADM X3 STUDY. THE SUBJECT ANSWERED "NO" FOR SATISFACTION OF HIP REPLACEMENT. NO ADDITIONAL COMMENTS ON THE QUESTIONNAIRE. X-RAYS AND ADDITIONAL QUESTIONNAIRES WERE NOT COMPLETED AT THE VISIT. (NOTE: PATIENT ALSO ANSWERED NO TO 'DO YOU HAVE ANY PAIN THAT WAS IN YOUR HIP THAT HAS THE STUDY HIP REPLACEMENT?')

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823925 ↗
• DeathSep 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ITS ALLEGED BY THE PATIENT'S SON, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT HIP HEMIARTHROPLASTY ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT AFTER IMPLANTATION THE PATIENT EXPERIENCED PAIN, INFECTION, THYROID PROBLEMS, LEG LENGTH DISCREPANCY, WEIGHT GAIN, SKIN RASHES AND FATIGUE. PATIENT SUBSEQUENTLY DIED.

  Patient problems: Ambulation or Postural Difficulties; Death; Fatigue; Pain; Rash; Thyroid Problems; Unspecified Infection

  MAUDE report 7868352 ↗
• InjuryDec 22, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT HAD A BIPOLAR HIP REPLACEMENT ON NOVEMBER 4TH OF THIS YEAR, IMPLANT SUBSIDED AND CAUSED THE PATIENT PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7142862 ↗

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