Masterloc Femoral Stems 01.39.205Recalls & reported problems
Medacta International SA · Masterloc Cementless Ti Coated LAT 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030885655), received between Apr 6, 2018 and Oct 3, 2022 — classified as 5 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
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Loose or Intermittent Connection1
- Patient Device Interaction Problem1
Patient problems
- Joint Disorder2
- Hip Fracture1
- Implant Pain1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 4 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS. THE STEM WAS REVISED BECAUSE THE HEAD WAS ALREADY SHORT AND IT WAS NOT POSSIBLE TO GO TO A SHORTER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 15526931 ↗InjurySep 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT CAME IN, 9 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY IS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 10572821 ↗InjuryMay 27, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD MORE THAN 1 YEAR AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 10091699 ↗InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE HEAD AND STEM ALMOST 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 9086481 ↗InjuryApr 6, 2018Fracture
A PATIENT HAD A PERI-PROSTHETIC FRACTURE FOUND THROUGH X-RAY TAKEN SURGEON TWO DAYS AFTER PRIMARY. SURGEON REVISED THE IMPLANT WITH QUADRA- R SIZE#1 SUCCESSFULLY. CERCLAGE APPLIED.
Patient problems: Hip Fracture
MAUDE report 7402529 ↗
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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