SMS StemRecalls & reported problems across all models
Medacta International SA · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls
- 0
We found 28 models of SMS Stem 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 Oct 2, 2019 and Sep 16, 2026 — classified as 76 injuries, 1 malfunction.
The most frequently reported specific device problem is “Osseointegration Problem” (17 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 SMS Stem problems
Device problems
- Osseointegration Problem17
- Adverse Event Without Identified Device or Use Problem10
- Appropriate Device Problem Term/Code Not Available10
- Fracture9
- Migration9
- Loosening of Implant Not Related to Bone-Ingrowth6
- Device Appears to Trigger Rejection4
- Migration or Expulsion of Device4
Patient problems
- Bone Fracture(s)18
- Inadequate Osseointegration18
- Pain13
- Aseptic loosening7
- Implant Pain7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Medical device site infection5
- Unequal Limb Length3
SMS Stem models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SMS Stem 01.36.047Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented7 reports
- SMS Stem 01.36.044Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented6 reports
- SMS Stem 01.36.045Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- SMS Stem 01.36.048Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- SMS Stem 01.36.070Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- SMS Stem 01.36.051Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- SMS Stem 01.36.067Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- SMS Stem 01.36.069Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- SMS Stem 01.36.046Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- SMS Stem 01.36.053Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- SMS Stem 01.36.071Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- SMS Stem 01.36.144Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- SMS Stem 01.36.147Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- SMS Stem 01.36.043Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.050Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.052Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.065Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.146Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.165Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.166Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- SMS Stem 01.36.073Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.150Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.163Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.167Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.168Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.169Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.173Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- SMS Stem 01.36.076Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Recent SMS Stem adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Migration or Expulsion of Device
The patient came in presenting pain due to a fracture and subsided stem and the cause is unknown. About 2 years and 9 months after the primary surgery, the surgeon revised the stem and head. Patient`s bone quality good (65 years old), the fracture was already healed at the time of the revision. M-vizion stem implanted.
Patient problems: Bone Fracture(s); Implant Pain
MAUDE report 50784460 ↗InjuryJul 8, 2026Fracture
REVISION SURGERY DUE TO A PERIPROSTHETIC FRACTURE AFTER ABOUT 2 YEARS AND 2 MONTHS FROM PRIMARY SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM. THE SURGEON ALSO REVISED THE D 36/E HOODED PE HC LINER TO A D 36/E FLAT PE HC LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 25747725 ↗MalfunctionMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
AT APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT EXPERIENCED IMPLANT LOOSENING. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: Aseptic loosening
MAUDE report 25275479 ↗InjuryMay 12, 2026Device Appears to Trigger Rejection
AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SMS SOLID STEM SIZE8 TO AN AMISTEM-C SIZE3, REVISED THE 28MM BIOLOX HEAD L TO A 40MM BIOLOX HEAD XL, AND REVISED THE D 28/DMF DOUBLE MOBILITY LINER TO A FACE CHANGING 10° HC LINER D 40/G. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25148979 ↗InjuryApr 2, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY AT 8 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING. THE SURGEON REVISED THE SMS COLLARED SOLID STEM SIZE 7 TO AN M-FINITY COLLARED STEM SIZE 10. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24762673 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PERIPROSTHETIC FEMUR FRACTURE 1 MONTH AFTER PRIMARY SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE SMS SOLID STEM TO AN AMISTEM P COLLARED SIZE5 STEM, THE D 28 DM LINER TO A SAME SIZE LINER, AND THE 20MM BIOLOX M HEAD TO A 28MM BIOLOX S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 24738816 ↗InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO STEM LOOSENING ABOUT 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE MEDACTA LINER TO A SAME SIZE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24711051 ↗InjuryMar 13, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CAME HAD PAIN AND INSTABILITY DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION TOWARDS TRAUMA OR A FALL. AT ABOUT 11 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA D 36 MPACT LINER TO A MEDACTA D 40 MPACT LINER, AND REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24588554 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
AT APPROXIMATELY 4 MONTHS AFTER THE PRIMARY PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF PAIN AND PERIPROSTHETIC FRACTURE WAS CONFIRMED. THE SURGEON COMMENTED THAT THE PATIENT`S LARGE BODY SIZE MAY HAVE CONTRIBUTED TO THE ISSUE. CABLE FIXATION PERFORMED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 24518512 ↗InjuryFeb 24, 2026Fracture
REVISION SURGERY ABOUT 2 WEEKS POST OP DUE TO FEMUR BONE FRACTURE. STEM AND HEAD REVISED SUCCESSFULLY. THE SURGEON REPORTED THAT THE FRACTURE IS LIKELY DUE TO A POOR BONE QUALITY OF THE PATIENT ASSOCIATED WITH A VARUS MORPHOLOGY OF THE FEMUR.
Patient problems: Medical device site infection
MAUDE report 24429840 ↗InjuryJan 29, 2026Osseointegration Problem
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM FROM A SMS COLLARED SOLID STEM TO A MINIMAX STEM AND REVISED THE LINER AND HEAD TO THE SAME SIZE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 24208612 ↗InjuryJan 8, 2026Osseointegration Problem
AT ABOUT 1 YEAR 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 24004377 ↗InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ON (B)(6) 2025, THE PATIENT HAD PRIMARY LEFT HIP SURGERY USING A MEDACTA HEAD AND STEM. A COMPETITOR'S LINER WAS USED. ON 20 (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH A MEDACTA HEAD AND STEM. THE SURGEON REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 23579960 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
AFTER 1 YEAR AND 5 MONTHS, THE PATIENT PRESENTED WITH PAIN OF UNKNOWN CAUSE. THE SURGEON DETERMINED THERE WAS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND REVISED THE HEAD AND LINER, UPSIZING THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 23461660 ↗InjurySep 19, 2025Implant subsidence; Implant subsidence
THE PATIENT HAD PAIN DUE TO A SUBSIDED STEM, AND THE CAUSE IS UNKNOWN. AT ABOUT 3 MONTHS AND A HALF POST PRIMARY THE SURGEON REVISED THE STEM FROM SMS LAT SIZE 5 TO AMIS LAT SIZE 8 AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 23093859 ↗
Other Medacta International SA products
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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