SMS Stem 01.36.069Recalls & reported problems
Medacta International SA · SMS Solid Stem LAT #9 · Class 2 · Implant
All models of SMS Stem (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030888816), received between Nov 18, 2021 and Dec 15, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (2 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, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
- Fracture1
- Osseointegration Problem1
Patient problems
- Pain2
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2023Migration; Migration
AT ABOUT 1 YEAR AND 11 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 STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 18334737 ↗InjuryJul 19, 2023Fracture; Fracture
THE PATIENT FELT A CRACK TWO WEEKS AFTER THE PRIMARY HIP SURGERY, BUT WAS SEEN BY THE KNEE REPLACEMENT SURGEON (THE PATIENT IS BILATERAL AND ALSO HAS A TKA; ON THE SAME SIDE OF THE BROKEN STEM), WHO DID NOT PROCEED WITH FURTHER INVESTIGATIONS. THE PATIENT THEN CONTINUED WALKING FOR ANOTHER TWO WEEKS BEFORE PRESENTING TO THE PRIMARY HIP SURGERY SURGEON. ABOUT 1 MONTH AND 1 WEEK AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO STEM NECK BREAKAGE AND CERAMIC LINER BREAKAGE.
Patient problems: Pain
MAUDE report 17349876 ↗InjuryFeb 14, 2022Osseointegration Problem; Osseointegration Problem
AT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 13523997 ↗InjuryNov 18, 2021Migration; Migration
AT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A REVISION DUE TO STEM SUBSIDENCE AND MOBILIZATION.
Patient problems: Insufficient Information
MAUDE report 12834860 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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