Masterloc Femoral StemsRecalls & reported problems across all models
Medacta International SA · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls
- 0
We found 21 models of Masterloc Femoral Stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Jul 4, 2017 and Dec 23, 2025 — classified as 74 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Masterloc Femoral Stems problems
Device problems
- Appropriate Device Problem Term/Code Not Available14
- Adverse Event Without Identified Device or Use Problem11
- Osseointegration Problem9
- Loose or Intermittent Connection8
- Fracture6
- Loosening of Implant Not Related to Bone-Ingrowth6
- Migration5
- Unstable3
Patient problems
- Bone Fracture(s)16
- Inadequate Osseointegration16
- Pain14
- Joint Disorder12
- Hip Fracture5
- Implant Pain4
- Insufficient Information4
- Unspecified Infection3
Masterloc Femoral Stems models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Masterloc Femoral Stems 01.39.203Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- Masterloc Femoral Stems 01.39.206Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- Masterloc Femoral Stems 01.39.207Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- Masterloc Femoral Stems 01.39.208Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented6 reports
- Masterloc Femoral Stems 01.39.205Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Masterloc Femoral Stems 01.39.209Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Masterloc Femoral Stems 01.39.008Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- Masterloc Femoral Stems 01.39.006Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Masterloc Femoral Stems 01.39.202Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Masterloc Femoral Stems 01.39.204Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Masterloc Femoral Stems 01.39.210Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Masterloc Femoral Stems 01.39.212Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Masterloc Femoral Stems 01.39.004Prosthesis, Hip, Hemi-, Femoral, Metal Ball2 reports
- Masterloc Femoral Stems 01.39.005Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Masterloc Femoral Stems 01.39.009Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Masterloc Femoral Stems 01.39.011Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Masterloc Femoral Stems 01.39.012Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Masterloc Femoral Stems 01.39.003Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Masterloc Femoral Stems 01.39.007Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Masterloc Femoral Stems 01.39.010Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Masterloc Femoral Stems 01.39.211Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Recent Masterloc Femoral Stems adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT A PRIMARY HIP ARTHROPLASTY ON (B)(6) 2025. POST-OP X-RAYS IDENTIFIED A LEG LENGTH DISCREPANCY, WITH THE LEFT LEG LONGER THAN THE RIGHT. ON THE SAME DATE, THE SURGEON PERFORMED A REVISION AND REVISED THE HEAD FROM A 36 MM M TO A 36 MM S AND REVISED THE MASTERLOC STEM FROM SIZE 10 TO SIZE 8. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unequal Limb Length
MAUDE report 23876935 ↗InjuryNov 28, 2025Osseointegration Problem; Osseointegration Problem
REVISION SURGERY AFTER 7 YEARS AND 8 MONTHS POST-PRIMARY SURGERY DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 23669505 ↗InjurySep 10, 2025Osseointegration Problem; Osseointegration Problem
AT 2 YEARS AND 5 MONTHS THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 23014740 ↗InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY, THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 22394420 ↗InjuryMar 7, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT 5 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 21548760 ↗InjuryNov 6, 2024Migration; Migration
REVISION SURGERY DUE TO MASTERLOC STEM SUBSIDENCE, AT ABOUT 9 MONTHS FROM THE PRIMARY. THE SURGEON IMPLANTED AN AMIS-K WITH A CERAMIC HEAD. THE CUP NOT REVISED.
Patient problems: Insufficient Information
MAUDE report 20620132 ↗InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT 3 WEEKS FROM THE PRIMARY, REVISION SURGERY DUE TO THREE-PART FEMORAL BONE FRACTURES. PATIENT OVERWEIGHT. COMPETITOR'S DEVICE IMPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 20618490 ↗InjuryJul 10, 2024Osseointegration Problem; Osseointegration Problem
ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT COMPLAINED OF THIGH PAIN. THERE WAS NO SIGN OF INFECTION BUT THE X-RAYS SHOWED SIGNS OF STEM LOOSENING. DURING THE REVISION, THE STEM WAS PERFECTLY FIXED, SO THE SURGEON PLACED A SLEEVE AND REVISED THE HEAD.
Patient problems: Implant Pain
MAUDE report 19711156 ↗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 ↗InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE PRIMARY HIP SURGERY ON (B)(6) 2024, IT WAS OBSERVED THAT THE PATIENT HAD SUSTAINED AN INTRA-OP FRACTURE. THE SURGEON CABLED THE FRACTURE AROUND THE PROXIMAL PART AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE SURGEON NOTICED THAT THE FRACTURE WAS BELOW THE PROXIMAL PART. SINCE THE SURGEON DID NOT CABLE DISTALLY DURING THE PRIMARY, HE DECIDED TO REVISE THE PATIENT. THE STEM AND HEAD WERE SUBSTITUTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 18657246 ↗InjuryDec 19, 2023Osseointegration Problem; Osseointegration Problem
AT 6 YEARS AND 5 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 COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 18355810 ↗InjuryDec 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
AT ABOUT 5 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 18267224 ↗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 ↗MalfunctionNov 15, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
DURING THE PRIMARY HIP SURGERY, WHEN THE AGENT OPENED UP THE STEM IMPLANT, IT WAS OBSERVED THAT THE IMPLANT HAD BROKEN THROUGH THE STERILE PACKAGING AND THE CAUSE IS UNKNOWN. THE ISSUE WAS NOTED WHEN THE FEMORAL BONE WAS ALREADY PREPARED. THE SURGEON DECIDED TO RE-STERILIZE IT BECAUSE NO BACK-UP WAS AVAILABLE AND THEY COULD NOT GO DOWN OR UP IN SIZE. THE PIECE WAS RE-STERILIZED WITH STEAM STERILIZATION. THE ISSUE CAUSED 45-MINUTE DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY; ADDITIONAL ANESTHESIA WAS ADMINISTERED. ONLY ONE BLOCKER WAS INSIDE THE PACKAGING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18139035 ↗InjuryOct 18, 2023Migration; Migration
AT ABOUT THREE MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.
Patient problems: Implant Pain
MAUDE report 17957167 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page