AMIStem-H Proximal Coating Femoral Stems 01.18.182Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030804472), received between Mar 7, 2018 and Dec 2, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjurySep 7, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON BELIEVES THE STEM IS LOOSE. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2018.

  Patient problems: Pain

  MAUDE report 7854960 ↗
• InjuryMar 7, 2018Incorrect, Inadequate or Imprecise Result or Readings

  ON 06 FEBRUARY 2018 THE SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY IS PLANNED SINCE A PATIENT CAME IN WITH A LIMB LENGTH DISCREPANCY. ON (B)(6) 2018 THE SURGEON REVISED THE STEM AND HEAD AND REPLACED IT WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7319830 ↗