MiniMAX Stems 01.13.106RRecalls & reported problems
Medacta International SA · miniMAX Stem - Size 6 Right · Class 2 · Implant
All models of MiniMAX Stems (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030803260), received between Feb 2, 2018 and Dec 24, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Nov 15, 2017Class IITerminated
Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
Z-0196-2019 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Fracture2
- Inadequacy of Device Shape and/or Size1
- Osseointegration Problem1
Patient problems
- Bone Fracture(s)2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Aseptic loosening1
- Hip Fracture1
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 24, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM HEAD AND SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 23886580 ↗InjuryOct 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
FEMUR FRACTURE AT ABOUT 1 MONTH FROM PRIMARY. HEAD AND STEM WERE REVISED SUCCESSFULLY.
Patient problems: Hip Fracture
MAUDE report 20470018 ↗InjuryOct 1, 2020Inadequacy of Device Shape and/or Size
THE POST-OP X-RAYS TAKEN AFTER SURGERY INDICATED THAT THE STEM WAS UNDERSIZED. THE SURGEON DECIDED TO OPERATE ON THE PATIENT AGAIN (THE SAME DAY OF PRIMARY SURGERY) AND REVISED THE STEM SIZE 6 RIGHT WITH A SIZE 7 RIGHT AND THE CERAMIC HEAD. THE SURGERY WAS COMPLETE SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10612279 ↗InjuryMay 8, 2019Fracture
THE PATIENT CAME IN, 2 WEEKS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A VANCOUVER B2 FRACTURE AND THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 8591155 ↗InjuryFeb 6, 2019Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A SUBSIDED STEM AFTER ABOUT 18 DAYS FROM PRIMARY. THE SURGEON CHOSE TO LEAVE THE STEM IN PLACE BUT REVISED HEAD AND ADDED A SLEEVE OPTION.
Patient problems: Pain
MAUDE report 8310185 ↗InjuryFeb 2, 2018Fracture
REVISION DUE TO PERIPROSTHETIC FRACTURE (SLIGHTLY SPIRAL) DETECTED 4 DAYS AFTER PRIMARY. NO TRAUMA REPORTED BY THE PATIENT AND NO MICRO-FRACTURE WAS DETECTED THROUGH PER-OPERATIVE IMAGES.
Patient problems: Bone Fracture(s)
MAUDE report 7237247 ↗
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 · each recall links to the FDA recall notice
- 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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