Fitmore® 01.00551.303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024482876), received between Feb 20, 2020 and Mar 16, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2020Fracture; Migration; Fracture; Migration

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); No Known Impact Or Consequence To Patient

  MAUDE report 9835413 ↗
• MalfunctionFeb 20, 2020Fracture; Device Dislodged or Dislocated; Noise, Audible

  FROM STAFF: PHYSICAL THERAPIST WAS EVALUATING THIS PATIENT SAME DAY OF SURGERY FOR RIGHT TOTAL HIP REPLACEMENT. WHILE AMBULATING IN HALLWAY WITH FRONT WHEELED WALKER AND RETURNING TO BED, SUDDENLY HEARD A LOUD "CLUNK" FROM THE OPERATIVE SIDE. PATIENT THEN STATING THE OPERATIVE LEG FELT MUCH DIFFERENT THAN BEFORE WITH WEIGHT BEARING. WHEN RETURNING TO THE BED, PATIENT STATING IT FELT AS IF THE FOOT WAS GOING THROUGH THE FLOOR. FROM OP REPORT: PATIENT WHO UNDERWENT A PRIMARY RIGHT TOTAL HIP ARTHROPLASTY. THIS WAS PERFORMED UNDER SPINAL ANESTHESIA WITHOUT COMPLICATION. THE PATIENT DID WELL IN THE RECOVERY ROOM AND TRANSFERRED TO THE FLOOR. PATIENT WAS WALKING WITH PHYSICAL THERAPY WITHOUT DIFFICULTY WHEN THERE WAS AN AUDIBLE CRACK AND THE RIGHT LEG SHORTENED. PATIENT WAS PLACED BACK IN BED. PATIENT DID NOT HAVE SIGNIFICANT PAIN. THE X-RAY REVEALED A PERIPROSTHETIC FRACTURE WITH DISPLACEMENT OF A MEDIAL CALCAR FRAGMENT AND SIGNIFICANT SUBSIDENCE OF THE STEM. THE HIP REMAINED LOCATED. I SUSPECT THAT THERE IS A SMALL CALCAR CRACK THAT WAS NOT VISIBLE AT THE TIME OF THE PRIMARY STEM PLACEMENT. BECAUSE OF THE SIGNIFICANT AMOUNT OF SUBSIDENCE, I RECOMMENDED THAT WE PROCEED BACK TO THE OPERA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732273 ↗