Masterloc Femoral Stems 01.39.005Recalls & reported problems
Medacta International SA · Masterloc Cementless Ti Coated STD Stem # 5 · Class 2 · Implant
All models of Masterloc Femoral Stems (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030885549), received between Aug 28, 2019 and Jan 11, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
Device problems
- Loose or Intermittent Connection1
- Patient Device Interaction Problem1
Patient problems
- Inadequate Osseointegration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT IS A BILATERAL PATIENT. THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM (LEFT) AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO TRAUMATIC EVENT OR SIGNS OF INFECTION, SCANS SHOWED SOME MOVEMENT WITH NO KNOWN CAUSE. THE IMPLANT HAD INGROWTH AND FIXATION UPON REMOVAL.
Patient problems: Inadequate Osseointegration
MAUDE report 16136876 ↗InjuryAug 28, 2019Loose or Intermittent Connection
REVISION SURGERY PERFORMED AFTER 8 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, COCR HEAD AND THE LINER SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 8938864 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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