MiniMAX Stems 01.13.103LRecalls & reported problems
Medacta International SA · miniMAX Stem - Size 3 Left · Class 2 · Implant
All models of MiniMAX Stems (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030803192), received between Jun 1, 2018 and Mar 20, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
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
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration1
- Joint Disorder1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2019Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT HAS BEEN REVISED (USING QUADRA H STEM) 6 MONTHS AFTER PRIMARY SURGERY DUE TO PAIN AND STEM LOOSENING (THE STEM HAS SUBSIDED), INITIALLY THE STEM WAS PLACED IN VARUS POSITION AND PROBABLY UNDERSIZED. CONTRIBUTING FACTORS MAY ALSO BE RELATED TO METABOLIC BONE DISORDER THAT THE PATIENT HAS SUFFERED FROM.
Patient problems: Inadequate Osseointegration
MAUDE report 8436673 ↗InjuryJun 1, 2018Fracture
ABOUT 15 DAYS AFTER SURGERY THE SURGEON REVISED THE PATIENT FOR A FEMUR FRACTURE. STEM, HEAD AND LINER SUBSTITUTED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 7560661 ↗
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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