ABG 4845-0105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327050943), received between Jul 25, 2019 and Jul 22, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Corroded” (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 16, 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.

• InjuryJul 22, 2020Corroded; Corroded

  "CIRCUMSTANCES OF OCCURRENCE / DESCRIPTION OF FACTS : REVISION SURGERY PLANNED FOLLOWING CLINICAL OBSERVATIONS ON THE (B)(6) 2020 AFTER THE INSERTION OF A PTH ON (B)(6) 2017: PAIN WITH CRACKING, THE SCANNER REVEALS BURSITIS WITH POSTERIOR CALCIFICATION JUST BEHIND THE GREATER TROCHANTER. AFTER INCISION, AN ABUNDANT BLACKISH LIQUID WAS FOUND, THEN THE CERAMIC INSERT IN MULTIPLE FRIABLE PIECES (NO HEAD FRACTURES, MAJOR CORROSION OF THE STEM AND CUP). REPORTING STATUS: C CLINICAL CONSEQUENCES NOTED : SIGNIFICANT INFILTRATION OF THE SYNOVIUM AND MUSCLES BY METALLOSIS. MAJOR RISK OF PROSTHETIC INSTABILITY - INFECTIOUS RISK. CONSERVATIVE MEASURES AND ACTIONS TAKEN : REMOVAL OF AS MUCH CERAMIC AS POSSIBLE (MANY DEBRIS, IMPOSSIBLE TO REMOVE EVERYTHING) AND OF THE MUSCLE DUE TO THE RISK OF METALLOSIS. ANAPATHIC AND BACTERIOLOGICAL SAMPLING OF FLUID, SOFT TISSUE AND BONE. REPLACEMENT OF THE PROSTHESIS."

  Patient problems: Inflammation; Metal Related Pathology; Pain; Reaction

  MAUDE report 10307925 ↗
• InjuryJul 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  10 YEARS AFTER IMPLANTATION ((B)(6) 2009) THERE IS A DISCONNECTION OF THE STEM FROM THE PROSTHESIS HEAD. THERE WAS NO TRAUMA. THE STEM AND ACETABULUM ARE TIGHT. THE PROSTHESIS HEAD REMAINS IN THE ACETABULUM. PROSTHESIS HEAD: LFIT ANATOMIC V40 FEMORAL HEAD 36 + 5 MM REF 6260-9-236, LOT MER43W, SN (B)(4).

  Patient problems: Injury

  MAUDE report 8827906 ↗