Masterloc Femoral Stems 01.39.203Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030885631), received between May 18, 2018 and Feb 14, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH MEDACTA COMPONENTS AND REVISED THE MEDACTA LINER AND CUP WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18701124 ↗
• InjuryDec 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 5 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCTS, REVISED THE MEDACTA LINER WITH A MEDACTA LINER AND IMPLANTED A DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18267202 ↗
• InjuryApr 27, 2022Appropriate Device Problem Term/Code Not Available

  AT 2 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14218332 ↗
• InjuryNov 7, 2021Material Fragmentation; Material Fragmentation

  REVISION SURGERY PERFORMED DUE TO STEM NECK BREAKAGE 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY (STEM AND HEAD WERE REPLACED).

  Patient problems: Insufficient Information

  MAUDE report 12758191 ↗
• InjuryAug 31, 2021Migration; Migration

  1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12391682 ↗
• InjuryNov 27, 2019Appropriate Device Problem Term/Code Not Available

  THE SURGEON PERFORMED A REVISION SURGERY 9 MONTHS AFTER PRIMARY FOR INFECTION (ACNES BACTERIUM). STEM, CERAMIC LINER, CERAMIC HEAD AND SCREW REVISED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9383332 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY THE STEM SUBSIDING. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8211947 ↗
• InjuryDec 14, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 1 YEAR AND 6 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8164763 ↗
• InjuryJun 26, 2018Unintended Movement

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM HAD SUBSIDED 2 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE SUBSIDENCE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7637648 ↗
• InjuryMay 18, 2018Fracture

  DURING SURGERY THE FEMUR FRACTURED. THIS WAS DISCOVERED AFTER THE FINAL STEM HAD BEEN IMPLANTED AND THE SURGEON WAS TRIALING FOR THE HEAD SIZE. THE STEM WAS CEMENTED IN AND A PLATE PLACED OVER THE FRACTURE SITE (LATERAL AT DISTAL TIP OF STEM) USING CABLES AND SCREWS. THE SURGERY WAS DELAYED APPROXIMATELY 1 HOUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7525812 ↗