Masterloc Femoral Stems 01.39.206Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030885662), received between Mar 21, 2018 and Nov 8, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2022Migration; Migration

  X-RAYS REVEALED THAT THE PRIMARY STEM HAD SUBSIDED BY NEARLY 1 CM AND THE CAUSE IS UNKNOWN. REVISION SURGERY WAS PERFORMED AT ABOUT 4 MONTHS AFTER THE PRIMARY DUE TO THE LEG LENGTH DISCREPANCY. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15750750 ↗
• InjuryMar 8, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT 2 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13694211 ↗
• InjuryOct 13, 2021Output Problem

  3 DAYS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING TIGHTNESS IN THE HIP AND THE CAUSE OF THE TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE STEM (FROM SIZE 6 TO SIZE 5) AND HEAD (FROM SIZE S TO SIZE L) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 12623812 ↗
• InjuryApr 21, 2021Malposition of Device; Malposition of Device

  IMMEDIATELY AFTER THE PRIMARY HIP SURGERY, WHEN THE SURGEON TOOK POST-OP X-RAYS, IT WAS OBSERVED THAT THE PATIENT HAD A MISPLACED FEMORAL COMPONENT. THE SURGEON DECIDED TO REVISE THE PATIENT IMMEDIATELY AND SWAPPED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11699788 ↗
• InjuryJan 20, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO STEM LOOSENING, 4 YEARS 4 MONTHS AFTER THE PRIMARY. TESTS SHOWED THAT THE PATIENT HAD AN ALLERGIC REACTION TO NICKEL. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Dislocation

  MAUDE report 11200885 ↗
• InjuryAug 11, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON WAS UNABLE TO REMOVE THE STEM AND HAD TO PERFORM AN OSTEOTOMY OF THE FEMUR TO REMOVE THE STEM THUS, CABLES WERE NEEDED. ALSO THE HEAD HAS BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY 2 YEARS AND 3 MONTHS AFTER PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 10389667 ↗
• InjuryJan 8, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN, 2 YEARS AND 9 MONTHS, COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9563216 ↗
• InjuryJul 30, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A SUBSIDED STEM. THE SURGEON REVISED THE HEAD AND STEM ABOUT 1 YEAR AND 6 AND A HALF MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8840210 ↗
• InjuryMar 21, 2018Fracture

  THE PATIENT CAME IN DUE TO PAIN 1 MONTH AFTER PRIMARY. THE X-RAY SHOWED THAT THE FEMORAL BONE WAS FRACTURED SPIRALLY FROM PROXIMAL SIDE TO DISTAL SIDE OF THE FEMORAL STEM. THE SURGEON REPLACED WITH COMPETITORS LONG CEMENT STEM AND THE FEMORAL BONE WAS FIXED WITH A WIRE. ACETABULAR CUP WAS NOT REPLACED. THE PATIENT DID NOT FALL DOWN AND DID NOT HAVE THE EXPERIENCE OF ANY TRAUMA.

  Patient problems: Hip Fracture

  MAUDE report 7357665 ↗