Alteon 180-65-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862272652), received between Apr 24, 2023 and Jan 29, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bursitis; Joint Impingement; Osteolysis; Synovitis

  MAUDE report 21264295 ↗
• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bursitis; Joint Impingement; Osteolysis; Synovitis

  MAUDE report 21264190 ↗
• 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 CONTRIBU

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

  MAUDE report 21078712 ↗
• InjuryNov 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA: RELATED (B)(4) RH REV. AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 6 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023: DIAGNOSIS: FAILED LEFT TOTAL HIP REPLACEMENT. THE ABDUCTOR MUSCLE BELLY WAS RETRACTED, ASPIRATED THROUGH THE HIP CAPSULE AND OBTAINED 20 ML OF SEROSANGUINEOUS FLUID THAT WAS SENT FOR CULTURES. THERE WAS AN OBVIOUS ADVERSE LOCAL TISSUE REACTION WITH A LOT OF BROWN VILLONODULAR SYNOVITIS THROUGHOUT THE WOUND. A THOROUGH SYNOVECTOMY AS THE CASE PROCEEDED AND SENT TISSUE FOR CULTURE AND ALSO TISSUE FOR PATHOLOGY. THE HIP WAS ROTATED AND TUCKED THE TRUNNION POSTERIORLY AND EXPOSED THE ACETABULUM. DEBRIDEMENT OF THE ADVERSE TISSUE AND THE SYNOVITIS WAS COMPLETED. THE RIM HAD POLY WEAR. THERE WAS OSTEOLYSIS AROUND THE SCREW HOLES, GREATER ON THE POSTERIOR SIDE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD AND SMARTSOL

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

  MAUDE report 20621196 ↗
• MalfunctionApr 24, 2023Positioning Failure; Positioning Failure

  AS REPORTED, DURING SURGICAL USE, BASICALLY DOING A TOTAL HIP ON A PATIENT, AFTER PLACING THE CUP SURGEON HAD ISSUES GETTING THE ACETABULAR SCREWS TO SIT DOWN. LINER THEN WOULDN¿T FULLY SEAT, AFTER PULLING THE LINER WE COULD SEE INDENTATIONS ON IT WHERE THE SCREWS WERE PUSHING ON IT. HE HAD TO BURN THE LINER AND REMOVE HIS SCREW FIXATION TO GET THE LINER TO SEAT. ESSENTIALLY HAD TO ABANDON SCREW FIXATION TO GET A LINER TO SEAT. ONCE THE SCREWS WERE REMOVED, THE LINER WAS ABLE TO BE SEATED. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801007 ↗
• MalfunctionApr 24, 2023Positioning Failure; Positioning Failure

  AS REPORTED, DURING SURGICAL USE, BASICALLY DOING A TOTAL HIP ON A PATIENT, AFTER PLACING THE CUP SURGEON HAD ISSUES GETTING THE ACETABULAR SCREWS TO SIT DOWN. LINER THEN WOULDN'T FULLY SEAT, AFTER PULLING THE LINER WE COULD SEE INDENTATIONS ON IT WHERE THE SCREWS WERE PUSHING ON IT. HE HAD TO BURN THE LINER AND REMOVE HIS SCREW FIXATION TO GET THE LINER TO SEAT. ESSENTIALLY HAD TO ABANDON SCREW FIXATION TO GET A LINER TO SEAT. ONCE THE SCREWS WERE REMOVED, THE LINER WAS ABLE TO BE SEATED. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16800950 ↗