AML 1554-02-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295058311), received between Apr 3, 2019 and Mar 1, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2023Fracture; Fracture

  HCP IS REPORTING TO NCA/BFARM: "PAIN LEFT THIGH AND HIP SINCE YEARS. FALL IN DOMICILE ON (B)(6) 2023, THEN THE ENTIRE NIGHT LYING ON THE FLOOR. NURSING SERVICE FOUND PATIENT THE NEXT MORNING AND PICKED HIM UP. ANOTHER FALL ON (B)(6)2023. NOW PRESENTATION IN THE HOSPITAL RADEBEUL. THERE IN THE X-RAY A STEM-FRACTURE WAS DIAGNOSED. TRANSFER TO DRESDEN MUNICIPAL HOSPITAL, ORTHOPEDICS FOR FURTHER CARE. REVISION SURGERY WITH REPLACEMENT OF THE STEM ON (B)(6) 2023."

  Patient problems: Fall; Pain

  MAUDE report 16459187 ↗
• InjuryMay 28, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  SURGEON REPORTED TO (B)(6): "TRANSFERRAL FROM ORTHOPEDIC OUTPATIENT DEPARTMENT BECAUSE OF STEM FRACTURE - PROSTHESIS WITH SIGNS OF LOOSENING. NO TRAUMA IN ANAMNESIS. REVISION OF STEM TO MODULAR CEMENTLESS STEM WITH WIRE-OSTEOSYNTHESIS ON (B)(6) 2020."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 10098478 ↗
• InjuryApr 3, 2019Biocompatibility; Biocompatibility

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, MULTIPLE DISLOCATIONS AND A PSEUDOTUMOR. UPDATE REC'D 7/21/2014-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PRIMARY OPERATIVE NOTE STATES A MARATHON LINER WAS IMPLANTED, BUT THE STICKER SHEET SHOWS THAT A METAL LINER WAS ACTUALLY IMPLANTED. THE PFS ALSO STATES THE PATIENT WAS REVISED ON (B)(6) 2014 FOR A PSEUDOTUMOR, BUT THERE NO MEDICAL RECORDS AT THIS TIME TO CONFIRM THIS REVISION DATE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 8/5/2014. UPDATE 1/20/2016-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED ON (B)(6) 2014 FOR INFECTION, PAIN DISLOCATION, AND CLICKING/POPPING SOUNDS. ALL IMPLANTS EXCEPT FOR THE STEM WERE EXPLANTED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2014. AT THIS TIME INFECTION ISN'T ALLEGED PER LITIGATION. THE CUP AND HOLE ELIMINATOR ARE BEING ADDED TO THE COMPLAINT, BUT NOT REPORTED AS THEY WERE IMPLANTED MORE THAN 10 YEARS BEFORE BEING REMOVED. THERE WAS NO MENTION OF A PSEUDOTUMOR.

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8478049 ↗