Secur-Fit 6052-0830SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327021110), received between May 30, 2017 and Mar 13, 2025 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. THE STEM AND HEAD WERE REVISED. REP CONFIRMED THAT THERE WERE NO ADDITIONAL INTRA-OPERATIVE FINDINGS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 21593565 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD HER RIGHT HIP REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE."

  Patient problems: Bone Fracture(s)

  MAUDE report 16608471 ↗
• InjuryJul 19, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY TOTAL HIP ARTHROPLASTY WITH SUREFIT STEM AND 32 MM +5 HEAD AND TRIDENT CUP. THE PATIENT LATER PRESENTED WITH A PAINFUL RIGHT HIP AND REQUIRED A REVISION DUE TO POSSIBLE TRUNNIONOSIS AND POSSIBLE PSEUDOTUMOR. INITIAL REPORTER CONFIRMED TRUNNIONOSIS WAS PRESENT & PSEUDOTUMOR WAS SENT TO PATHOLOGY FOR ANALYSIS.

  Patient problems: Cancer; Pain

  MAUDE report 15050775 ↗
• InjuryOct 27, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO STEM SUBSIDENCE. A SECURFIT STEM AND BIOLOX HEAD WERE REVISED TO COMPETITOR IMPLANTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, PROVIDED PRIMARY USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12704313 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION OF PRIMARY THE PATIENT STATED SHE HAD A RIGHT THA DONE (B)(6) 2007. PATIENT STARTED TO EXPERIENCE PAIN APPROX IN 2011. IN (B)(6) 2020 PATIENT HAD AN MRI AND BLOOD WORK DONE WHICH SHOWED SHE HAD HIGH COBALT LEVELS AND MRI SHOWED LARGE PSEUDOTUMORS. THE PATIENT WAS REVISED ON (B)(6) 2020. AFTER REVISION THE PATIENT EXPERIENCED A LARGE HEMATOMA ON HER RIGHT HIP. THE PATIENT STATED THE HEMATOMA WAS DRAINED THREE TIMES BUT IT KEEPS COMING BACK. THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2021 TO REMOVE THE HEMATOMA, ANY PRESENT METALS AND PUT A DRAIN FOR ABOUT 5 DAYS. PATIENT IS SEEKING COMPENSATION.

  Patient problems: Inflammation

  MAUDE report 11497460 ↗
• InjuryFeb 12, 2020Insufficient 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 WAS CONVERTED FROM A HEMI HIP TO A TOTAL HIP. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD AND BIPOLAR COMPONENT.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9702551 ↗
• InjuryJul 29, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ORIGINAL RIGHT HIP DONE (B)(6) 2014. REVISION OF HEAD AND STEM DUE TO SUBSIDENCE.

  Patient problems: Injury

  MAUDE report 8837183 ↗
• InjuryNov 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8059790 ↗
• InjuryAug 28, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM LOOSENING (CAUSES OR CONTRIBUTORS TO LOOSENING NOT REPORTED). PATIENT WAS REVISED TO A RESTORATION MODULAR STEM WITH A NEW HEAD AND LINER.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7822894 ↗
• InjuryAug 16, 2018Degraded; Device Damaged by Another Device; Material Deformation; Insufficient Device Problem Information; Degraded; Device Damaged by Another Device; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO IMPINGEMENT. SURGEON ALSO REPORTED SUSPICION OF INFECTION WITH EVIDENCE OF POLY WEAR CITED AS THE CAUSE. INTRA-OPERATIVELY, NO VISUAL EVIDENCE OF POLY WEAR WAS FOUND. PATIENT WAS REVISED TO A SPACER INCLUDING A 6 X 127 HFX STEM. THE TRUNNION OF THE STEM WAS IMPINGING WITH THE CUP. SALES REP BELIEVES THAT INFECTION WAS CONFIRMED TO PROMPT IMPLANTATION OF A FIRST STAGE ANTIBIOTIC SPACER.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7789288 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF THIGH PAIN. INTRA-OPERATIVELY, IT WAS DISCOVERED THAT PATIENT SUFFERED A FEMORAL FRACTURE AT THE DISTAL END OF WHERE THE FEMORAL STEM WAS. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT.

  Patient problems: Bone Fracture(s); Injury; Pain

  MAUDE report 7675520 ↗
• InjuryMar 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT FELL AND SUSTAINED A PERIPROSTHETIC FRACTURE OF HER FEMUR. REP NOTED THAT THE BIPOLAR COMPONENT WAS EXPLANTED AND THEN RE-IMPLANTED IN THE PATIENT.

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

  MAUDE report 7338975 ↗
• InjuryMay 30, 2017Migration or Expulsion of Device; Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Migration or Expulsion of Device; Loss of Osseointegration

  SALES REP REPORTED A RIGHT HIP REVISION DUE TO SUBSIDED STEM OF PATIENT. SURGEON REVISED ANOTHER SURGEON REVISION AT THE SAME HOSPITAL. AS PER SALES REPRESENTATIVE, PATIENT FELL AND ON (B)(6) 2017, A TROCHANTER PLATE WAS IMPLANTED. THE PLATE WAS NOT A STRYKER DEVICE. NO OTHER DEVICES WERE REMOVED.

  Patient problems: Fall; Inadequate Osseointegration; Injury

  MAUDE report 6597557 ↗

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