ANTHOLOGY 71356108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010567901), received between Oct 15, 2021 and Nov 29, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A HIP REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT WAS WALKING ACROSS HIS KITCHEN ON 19-SEP-2023 WHEN FELT A SNAP AND, SUDDENLY, HIS RIGHT LOWER EXTREMITY COLLAPSED FROM UNDER HIM AND WAS UNABLE TO BEAR WEIGHT AFTERWARDS. THE EVENT WAS COMPLETELY ATRAUMATIC. THE PATIENT INITIALLY PRESENTED TO AN OUTSIDE HOSPITAL AND WAS NOTED TO HAVE FAILURE OF HIS RIGHT FEMORAL IMPLANT; THEN THE PATIENT WAS TRANSFERRED TO UMMC ON (B)(6) 2023, WHERE THE STEM AND HEAD WERE REVISED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 18234288 ↗
• InjuryFeb 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON 2021, THE PATIENT EXPERIENCED PAIN WHEN WALKING AND LOOSENING OF IMPLANT. THE DOCTOR STATED THAT HE MAY HAVE TO HAVE CORRECTIVE SURGERY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 13620552 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT AFTER A LEFT THA WAS PERFORMED ON (B)(6) 2016, PLAINTIFF EXPERIENCED INCREASING PAIN, EFFUSION ON LEFT HIP, AND HEMATOMA ON THE HIP. AN IRRIGATION AND DEBRIDEMENT OF HEMATOMA, AND DEBRIDEMENT OF LEFT TROCHANTERIC BURSA WAS PERFORMED ON (B)(6) 2019 TO INITIALLY TREAT THESE ADVERSE EVENTS. HOWEVER, PLAINTIFF CONTINUED HAVING ISSUES, INCLUDING HIGH COBALT LEVELS ON BLOOD ((B)(6) 2019: COBALT 19 MCG/L). DUE TO THIS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. DURING SURGERY ALL THE S+N DEVICES WERE EXPLANTED, AND NEW DEVICES WERE IMPLANTED. AFTER THE REVISION SURGERY, THE PLAINTIFF EXPERIENCED MULTIPLE INTERVENTIONS INCLUDING A SECOND REVISION SURGERY AND OPEN REDUCTION WITH INTERNAL FIXATION OF LEFT PELVIS FRACTURE, HOWEVER SINCE THERE IS NO INFORMATION ABOUT THE MANUFACTURER FOR ALL DEVICES IMPLANTED ON THE FIRST REVISION SURGERY, DETERMINATION IF SOME OF THE DEVICES ARE FROM S+N CANNOT BE CONCLUDED. A CORRELATION BETWEEN THESE EVENTS AND OUR DEVICES CANNOT BE STABLISH. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hematoma; Infiltration into Tissue; Inflammation; Pain; Swelling/ Edema

  MAUDE report 12639003 ↗