MiniMAX StemsRecalls & reported problems across all models
Medacta International SA · 18 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 1
We found 18 models of MiniMAX Stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2017 and Dec 24, 2025 — classified as 48 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 reports).
1 FDA recall record name at least one of these models by its device 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. 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
MiniMAX Stems recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 18 of these models · Recall details · FDA record ↗
Most reported MiniMAX Stems problems
Device problems
- Fracture15
- Appropriate Device Problem Term/Code Not Available13
- Loose or Intermittent Connection5
- Osseointegration Problem5
- Adverse Event Without Identified Device or Use Problem4
- Inadequacy of Device Shape and/or Size3
- Packaging Problem3
- Break2
Patient problems
- Bone Fracture(s)16
- Joint Disorder9
- Inadequate Osseointegration7
- No Known Impact Or Consequence To Patient4
- Pain4
- Unspecified Infection4
- Hip Fracture3
- No Information2
MiniMAX Stems models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MiniMAX Stems 01.13.105LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall8 reports
- MiniMAX Stems 01.13.104LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall6 reports
- MiniMAX Stems 01.13.106RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall6 reports
- MiniMAX Stems 01.13.103RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall5 reports
- MiniMAX Stems 01.13.105RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall5 reports
- MiniMAX Stems 01.13.102RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall4 reports
- MiniMAX Stems 01.13.104RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall4 reports
- MiniMAX Stems 01.13.106LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall4 reports
- MiniMAX Stems 01.13.102LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.103LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.107LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.108LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.108RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.100LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.100RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.101LProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.101RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.107RProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
Recent MiniMAX Stems adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE PRIMARY TOTAL HIP ARTHROPLASTY (THA) IN 2021, THE PATIENT SUSTAINED A FRACTURE THAT WAS TREATED WITH CERCLAGE. FROM THE OUTSET, SHE EXPERIENCED LIMPING AND PAIN, WHICH EVENTUALLY LED TO A REVISION OF THE IMPLANT AT 3 YEARS AND 11 MONTHS POST PRIMARY. DURING THE REMOVAL, THE MINIMAX STEM, DESPITE THE ABSENCE OF A LARGE PORTION OF THE GREATER TROCHANTER AND THE PROXIMAL PERIPROSTHETIC BONE, WAS FOUND TO BE VERY STABLE. IT WAS REPLACED WITH A MODULAR M-VIZION STEM. THE ACETABULAR COMPONENT WAS LEFT UNTOUCHED, AS IT WAS FOUND TO BE INTACT AND STABLE.
Patient problems: Pain
MAUDE report 22334724 ↗InjuryMar 13, 2025Osseointegration Problem; Osseointegration Problem
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. ON (B)(6) 2024, THE SURGEON REVISED THE MEDACTA STEM, HEAD AND LINER WITH ANOTHER MEDACTA STEM, HEAD AND LINER. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 21591415 ↗InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD PAIN AFTER TWISTING THE HIP. NO PROBLEM WITH THE DEVICES. THE FEMUR FRACTURED. AT ABOUT 3 WEEKS FROM PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Hip Fracture
MAUDE report 21229329 ↗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 ↗InjuryAug 22, 2024Osseointegration Problem; Osseointegration Problem
THE PATIENT HAS A PRIMARY HIP SURGERY ON (B)(6) 2016. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. ON (B)(6) 2021, THE SURGEON REVISED THE STEM, HEAD AND LINER. (MDR 2021-00641) (B)(6) 2024: THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM, AND REVISED THE MEDACTA HEAD AND LINER WITH ANOTHER MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 20033012 ↗InjuryJul 11, 2024Osseointegration Problem; Osseointegration Problem
MINIMAX STEM MOBILIZED AND ROTATED IN THE PATIENT'S FEMUR. STEM AND HEAD REVISED AT ABOUT 3 MONTHS FROM THE PREVIOUS REVISION SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 19719882 ↗InjuryJun 14, 2023Osseointegration Problem; Osseointegration Problem
AT ABOUT 1 YEAR 4 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 MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 17123885 ↗InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM WHERE DURING THE REVISION SURGERY AN OSTEOTOMY OF THE FEMUR TO REMOVE THE STEM WAS NECESSARY. THE SURGEON USED CABLES AND REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR. THE SURGEON REVISED THE STEM WITH A COMPETITOR STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 15444795 ↗InjuryApr 21, 2022Inadequacy of Device Shape and/or Size
THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN WAS UNKNOWN. AT 2 WEEKS FORM PRIMARY THE SURGEON DETERMINED THAT THE PATIENTS STEM WAS UNDERSIZED AND THE FEMUR BONE FRACTURED. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 14165859 ↗InjuryJan 28, 2022Fracture; Fracture
REVISION SURGERY WAS PERFORMED DUE TO STEM NECK BREAKAGE. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. ON (B)(6) 2020 THE HEAD, LINER, AND CUP WERE REVISED DUE TO JOINT DISLOCATION. DURING THE FIRST REVISION SURGERY, THE HEAD PUT IN WAS A MERETE BIO BALL WITH A LONG ADAPTER.
Patient problems: Insufficient Information
MAUDE report 13384920 ↗InjuryJun 24, 2021Loose or Intermittent Connection
THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2017. ON (B)(6) 2020, THE PATIENT CAME IN THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM (UNKNOWN CAUSE). THE SURGEON REVISED THE STEM, HEAD, AND LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 12056288 ↗InjuryApr 9, 2021Fracture
2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A PREPROSTHETIC FEMUR FRACTURE THAT WAS CAUSED BY DISMOUNTING A HORSE(NO TRAUMA). THE SURGEON CABLED THE FRACTURE, REVISED THE STEM AND HEAD WITH A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 11640105 ↗InjuryDec 9, 2020Migration; Migration
4 WEEKS AFTER PRIMARY THR. PATIENT CAME TO THE CLINIC COMPLAINING ON PAIN. X-RAYS SHOW SUBSIDENCE OF THE FEMORAL STEM AND FRACTURE OF THE CALCAR. REVISION OF THE STEM PERFORMED WITH DIFFERENT MANUFACTURER STEM. IT SHOULD BE NOTED THAT THE PATIENT HAS SEVERE OSTEOPOROSIS.
Patient problems: Bone Fracture(s)
MAUDE report 10975810 ↗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 ↗
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.
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