Alteon 180-65-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862272669), received between May 14, 2020 and Jan 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryJan 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2018. THEY UNDERWENT RIGHT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 4 YEARS 8 MONTHS AFTER THEIR INITIAL IMPLANTATION. THE PATIENT CLAIMS TO HAVE SUFFERED FROM EXTREME PAIN, LIMPING, INSTABILITY AND A REVISION SURGERY AS A RESULT OF THIS DEVICE. PATIENT EXPERIENCED PROTHESIS WEAR, LOOSENING, SYNOVITIS, FAILURE OF IMPLANT, OSTEOLYSIS, JOINT LAXITY AND PAIN. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. PER THE REVISION OPERATIVE NOTES, "THE STEM WAS WELL FIXED. I [SURGEON] USED A BONE TAMP AND REMOVED THE CERAMIC HEAD. THE TRUNNION WAS IN GOOD CONDITION. ¿ I USED A SCREWDRIVER AND REMOVED THE ACETABULAR LINER AND COULD SEE SIGNIFICANT WEAR SUPEROLATERALLY. I USED A SCREWDRIVER AND REMOVED THE SCREWS IN THE ACETABULUM. THESE SCREWS NO LONGER HAD PURCHASE. THERE WAS OSTEOLYSIS AROUND THE SCREWS AND THEY WERE LOOSE. ¿ THE CUP WAS STABLE AND WELL FIXED." BASED ON THE EVENT DESCRIPTION, THE WEAR ON THE TIBIAL INSERT APPEARS TO BE UNEVEN. THIS COULD INDICATE INSTABILITY AND/OR RELATIVE COMPONENT MALPOSITION. ADDITIONALLY, THE POLYETHYLENE WEAR DEBRIS MAY HAVE CONTRIB

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 21078773 ↗
• InjuryMay 14, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE ON THIS (B)(6) FEMALE PATIENT, THE SURGEON BROKE OFF THE SCREW HEAD FROM THE SCREW BODY DURING INSERTION. IT WAS VERY HARD BONE AND THE TORQUE OF TRYING TO SEAT THE SCREW INTO THE ACETABULAR CUP CAUSED THE SCREW HEAD TO BREAK OFF. THE BROKEN SCREW HEAD WAS REMOVED HOWEVER THE SCREW BODY WAS LEFT INSIDE THE PATIENT. THE BODY OF THE SCREW WAS LEFT INSIDE THE PATIENT PAST THE HOLE OF THE ALREADY SEATED ACETABULAR CUP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10055614 ↗