AMIStem-H Proximal Coating Femoral StemsRecalls & reported problems across all models

We found 11 models of AMIStem-H Proximal Coating Femoral Stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2017 and Sep 9, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (9 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

Most reported AMIStem-H Proximal Coating Femoral Stems problems

AMIStem-H Proximal Coating Femoral Stems models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMIStem-H Proximal Coating Femoral Stems 01.18.173

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  7 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.174

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  6 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.175

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  6 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.182

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  4 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.172

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.176

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.171

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• AMIStem-H Proximal Coating Femoral Stems 01.18.177

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report
• AMIStem-H Proximal Coating Femoral Stems 01.18.178

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• AMIStem-H Proximal Coating Femoral Stems 01.18.184

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report
• AMIStem-H Proximal Coating Femoral Stems 01.18.186

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report

Recent AMIStem-H Proximal Coating Femoral Stems adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Revision surgery due to a periprosthetic fracture after about 9 years and 2 months from primary. The surgeon cabled the fracture and revised the Flat PE HC liner D 32/F to a Flat PE HC liner D 40/F at his discretion.

  Patient problems: Bone Fracture(s)

  MAUDE report 50692303 ↗
• InjuryDec 23, 2021Osseointegration Problem; Osseointegration Problem

  AT 3 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO STEM MOBILIZATION.

  Patient problems: Joint Laxity

  MAUDE report 13073517 ↗
• InjuryMay 27, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 6 WEEKS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO LEG LENGTH DISCREPANCY (THE LEG WAS 3 CM LONGER). ALL IMPLANTS REVISED. LOT NUMBERS AND PRIMARY DATE ARE UNAVAILABLE.

  Patient problems: Unequal Limb Length

  MAUDE report 11893149 ↗
• InjurySep 3, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AFTER PRIMARY SURGERY THE PATIENT STEM WAS REVISED FOR LOOSENING. THIS IS THE THIRD REVISION REPORTED ON THIS PATIENT FOR DIFFERENT REASONS SINCE THE PRIMARY SURGERY. THE CORRECT DATE AND LOCATION FOR THE FIRST REVISION IS NOT KNOWN.

  Patient problems: Joint Disorder

  MAUDE report 10486940 ↗
• InjuryAug 3, 2020Appropriate Device Problem Term/Code Not Available

  THE HIP OF THE PATIENT WAS REVISED ON THE (B)(6) 2020 (2 MONTHS AFTER PRIMARY) DUE TO THE LOOSENING OF THE HIP STEM. INITIALLY, HE WANTED TO CHANGE ONLY THE STEM, BUT SINCE THE SURGEON DID A PUNCTURE AND DISCOVERED A LOW-GRADE INFECTION, HE DECIDED ALSO TO CHANGE THE CUP AND THE LINER. NO MORE INFORMATION ABOUT THE INFECTION AGENT IS AVAILABLE. IT IS UNKNOWN IF THE LOOSENING IS RELATED TO THE INFECTION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 10354963 ↗
• InjuryJul 6, 2020Failure to Osseointegrate

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO TIGHT PAIN. THE STEM WAS FIXED, OSSEOINTEGRATION ON THE METAPHYSICAL PART AND NO OSSEOINTEGRATION ON THE DISTAL PART. NOW THE STEM WAS ALSO IMPLANTED WITH A VARUS INCLINATION AND THE DISTAL TIP WAS PUSHING AGAINST THE CORTICAL WALL OF THE FEMUR. THE STEM WAS A STD SIZE 5 AND WAS FAIRLY EASILY REMOVED WITH THE EXTRACTION SET. IT WAS INSTALLED CEMENTED QUADRA-C AND PUT SOME CERCLAGE WIRE ON THE GREAT TROCHANTER AND BELOW THE LESSER TROCHANTER.

  Patient problems: Joint Disorder

  MAUDE report 10232765 ↗
• InjuryApr 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO TIGHT PAIN. THE STEM WAS FIXED, OSTEOINTEGRATION ON THE METAPHYSICAL PART AND NO OSTEOINTEGRATION ON THE DISTAL PART. NOW THE STEM WAS ALSO IMPLANTED WITH A VARUS INCLINATION AND THE DISTAL TIP WAS PUSHING AGAINST THE CORTICAL WALL OF THE FEMUR. THE STEM WAS A STD SIZE 5 AND WAS FAIRLY EASILY REMOVED WITH THE EXTRACTION SET. IT WAS INSTALLED CEMENTED QUADRA-C AND PUT SOME CERCLAGE WIRE ON THE GREAT TROCHANTER AND BELOW THE LESSER TROCHANTER.

  Patient problems: Joint Disorder

  MAUDE report 9920158 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AFTER PRIMARY (THE EXACT PRIMARY DATE IS UNKNOWN) DUE TO PAIN AND EXTRA-ARTICULAR IMPINGEMENT (GREATER TROCHANTER AND PROXIMAL RIM OF ACETABULUM). STEM AND HEAD HAVE BEEN REPLACED DUE TO PAIN. ALSO THE LINER HAVE BEEN SWAPPED. STEM WAS PROXIMALLY WELL INTEGRATED (WHERE THERE IS THE COATING) AND DISTALLY LOOSE (IN GENERAL NOT A STEM LOOSENING BECAUSE IS A PROXIMAL FIXATION STEM).

  Patient problems: Joint Disorder

  MAUDE report 9909844 ↗
• InjuryJan 8, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM AND HEAD 1 YEAR AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9563215 ↗
• InjuryDec 2, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 1 YEAR AND 7 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9393524 ↗
• InjuryNov 6, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER THE PRIMARY DUE TO INFECTION AND OBSERVED SUBCUTAN SWELLING. THE KIND OF PATHOGEN IS UNKNOWN. ALL IMPLANTS HAVE BEEN REMOVED, PATHOGEN IS BEING ANALYZED. NO REIMPLANTATION AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9284521 ↗
• InjuryOct 30, 2019Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUBSIDED STEM. THE SURGEON PERFORMED AN EXTENDED TROCHANTERIC OSTEOTOMY AND REVISED THE STEM AND LINER ALMOST 2 YEARS AND 2 MONTHS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9254773 ↗
• InjurySep 27, 2019Inadequacy of Device Shape and/or Size

  REVISION SURGERY, AFTER 10 MONTHS FROM THE PRIMARY DUE TO PAIN. THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN WAS AN UNDERSIZED STEM. THE SURGEON REVISED THE HEAD AND STEM. WHEN THE SURGEON WAS REVISING THE STEM, IT WAS OBSERVED THAT THE STEM HAD IN GROWTH WHEN IT WAS EXPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9128783 ↗
• InjurySep 19, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE LINER AND THE STEM 1 YEAR 9 MONTHS AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9086482 ↗
• InjurySep 10, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  WE WERE INFORMED ON (B)(4) 2019 THAT A REVISION SURGERY, FOLLOWING A LOOSE STEM, WOULD HAVE BEEN PERFORMED ON (B)(6) 2019 (2 YEARS AND 9 MONTHS AFTER PRIMARY SURGERY). THE CAUSE OF THE LOOSENING ISN'T KNOWN. SINCE THE STEM WAS CHANGED, THE SURGEON ALSO CHANGED THE HEAD AND THE INLAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8979018 ↗

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