Secur-Fit 6051-1035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327021042), received between Nov 9, 2017 and Sep 18, 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.

• InjurySep 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN NOT REPORTED. THE PATIENT'S STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND ANOTHER HEAD.

  Patient problems: Pain

  MAUDE report 10552389 ↗
• InjuryJan 4, 2019Migration; Migration

  PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT (B)(6) 2017. SHE DID FINE UNTIL RECENT FOLLOW UP SHOWED SUBSIDENCE OF THE STEM. SHE HAD A LEG LENGTH DISCREPANCY. SHE WAS SCHEDULED FOR REVISION. THE STEM WAS REMOVED AND REPLACED WITH A RESTORATION MODULAR CONE CONICAL STEM. OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8218992 ↗
• InjuryDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE (POSSIBLE CAUSE/ CONTRIBUTOR FOR FRACTURE NOT REPORTED) PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH COMPETITOR CERCLAGE WIRE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8157513 ↗
• InjuryMay 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION CAUSED BY STEM SUBSIDENCE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7491324 ↗
• InjuryNov 9, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED. IT WAS REPORTED ON OPENING THE JOINT CAPSULE THAT THERE WAS METALLOSIS AND TRUNNIONOSIS, AND THE HEAD WAS LOOSE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7014242 ↗

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