Secur-Fit 6052-0935SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327021127), received between Apr 10, 2017 and Aug 22, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS CONVERTED FROM A HEMI TO A TOTAL HIP DUE TO THE MODULAR ENDO HEAD MIGRATING THROUGH THE ACETABULUM. INTRA-OPERATIVELY, METAL STAINING WAS NOTED AT THE JUNCTION OF THE STEM AND SLEEVE, AND SOME METAL STAINING IN THE SURROUNDING TISSUE.

  Patient problems: Foreign Body Reaction

  MAUDE report 15266751 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "LEFT HIP. REVISED STEM DUE TO PERIPROSTHETIC FRACTURE. SPOKE TO REP, WHO CONFIRMED FEMORAL FRACTURE AND THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED UNITRAX HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 13993232 ↗
• InjuryMar 2, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUBSIDENCE OF THE FEMORAL STEM. THE SURGEON REPORTED THE IMPLANTED STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY. THE STEM AND HEAD WERE REVISED TO A LARGER STEM AND ANOTHER FEMORAL HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED STEM OR HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9775645 ↗
• InjuryFeb 12, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SEVERE NOTCHING OF THE NECK OF THE STEM, LEADING TO SURGEON'S CONCERN THAT THE NECK OF THE STEM MAY BREAK OFF. SURGEON REPORTED THE REASON FOR NOTCHING WAS DUE TO IMPINGEMENT WITH THE MDM METAL LINER, NOT THE SHELL. INTRA-OPERATIVELY, A SIGNIFICANT AMOUNT OF METALLOSIS WAS NOTED IN THE PATIENT'S SOFT TISSUE. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, TRIDENT II SHELL, POLY LINER AND FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED ADM/ MDM POLY INSERT OR THE FEMORAL HEAD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9702658 ↗
• InjuryFeb 6, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DR. REVISED A RIGHT TOTAL HIP THAT WAS ORIGINALLY DONE ON (B)(6) 2019. PATIENT HAD DISLOCATED MULTIPLE TIMES. DR. FELT THE CUP WAS PLACED TOO VERTICALLY AND THE STEM WAS UNDERSIZED. HE REVISED THE ENTIRE HIP TO A TRIDENT II MULTI-HOLE CUP, MDM AND OMNIFIT HFX PRESS FIT STEM. UPDATE 13/JANUARY/2020: SPOKE TO REP. SURGEON ALSO FELT THAT THE IMPLANTED STEM WAS UNDERSIZED FOR THE PATIENT'S ANATOMY AND WAS REVISED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9678665 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. THE PATIENT'S HEMI HIP CONSTRUCT WAS REVISED TO A TOTAL HIP CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST ANY OF THE REVISED IMPLANTS, PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Fall; Hip Fracture; Injury

  MAUDE report 9495277 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A #9 SECURFIT MAX WITH A 48 +0 UNITRAX HEAD AND SLEEVE AND HAD A PERIPROSTHETIC FRACTURE. WE TOOK THE SECURFIT MAX STEM OUT, REDUCED THE FRACTURE, PLACED CABLES AROUND THE FEMUR, PUT IN A #8 OMNIFIT EON AND USED THE SAME HEAD AND SLEEVE THAT WE REMOVED. UPDATE: FRACTURE WAS AT PROXIMAL FEMUR. SURGEON REPORTED THE EXPLANTED SLEEVE AND HEAD HAD NO VISIBLE WEAR AND WERE RE-IMPLANTED IN THE PATIENT.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7809905 ↗
• InjuryJun 28, 2018Loss of Osseointegration; Loss of Osseointegration

  PT DISLOCATED WHILE WALKING. REVISION WAS DONE. ALL COMPONENTS REPLACED. REP. CONFIRMED DISLOCATION - HEAD DISLOCATED FROM LINER. REVISION CONSTRUCT INCLUDED AN ADM/MDM LINER CONSTRUCT. PER REP, REGARDING REVISION OF STEM AND CUP. "EVERYTHING WAS LOOSE AND NEEDED TO BE UPSIZED."

  Patient problems: Inadequate Osseointegration; Injury; Joint Dislocation

  MAUDE report 7645961 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. REP WAS NOT MADE AWARE OF ANY LOOSE/ BROKEN DEVICES OR OTHER PATIENT FACTORS THAT COULD DIRECTLY BE ATTRIBUTED TO REPORTED PAIN, OR ITS SEVERITY. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM AND AN UNKNOWN HEAD.

  Patient problems: Injury; Pain

  MAUDE report 7635281 ↗
• InjurySep 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SURGEON PERFORMED A REVISION OF PATIENT'S LEFT HIP DUE TO PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6864948 ↗
• InjuryApr 10, 2017Fracture; Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED A RIGHT TOTAL HIP REVISION, PATIENT FELL AND FRACTURED HIP. RESTORATION MODULAR STEM REPLACEMENT.

  Patient problems: Bone Fracture(s); Fall; Hip Fracture; Injury

  MAUDE report 6475681 ↗

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