Alteon 190-30-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862321077), received between Aug 5, 2022 and Oct 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K162732); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  ADDITIONAL INFORMATION RECEIVED 26-SEP-2024. PRE-OP DX: LOOSENING OF FEMORAL COMPONENT OF PROSTHETIC RIGHT HIP POST-OP DX: SAME. OP SUMMARY: WE USED HIS PREVIOUS ANTERIOR INCISION ELLIPSING OUT THE SCAR AND EXTENDING IT SLIGHTLY DISTALLY AND PROXIMALLY. THERE WAS SOME SIGNIFICANT SCAR TISSUE WITHIN THE TENSOR FASCIA LAYER AND THEN SIGNIFICANT SCAR TISSUE DEEP TO THAT. THE STEM WAS NOTED TO HAVE BONY OVERGROWTH CIRCUMFERENTIALLY AROUND THE PROXIMAL PART OF THE STEM ITSELF. WE NOTED SOME MOVEMENT OF THE STEM GROSSLY AT THIS POINT. THE STEM WAS NOTED TO HAVE SETTLED IN RETROVERSION. POSTERIORLY REMOVE SOME OSTEOPHYTES AND UPON DOING SO THE STEM WAS NOTED TO BE GROSSLY LOOSE AGAIN. STEM WAS REMOVED WITH RELATIVE EASE. THERE WAS NO BONY INGROWTH ON THE STEM. AT THIS POINT WE CONFIRMED THAT THIS WAS A EXACTECH STEM WITH CORRESPONDING POLYETHYLENE AND CUP ON THE ACETABULUM. AS MOST OF THE EXACTECH LINERS HAVE BEEN RECALLED THE DECISION WAS MADE TO REMOVE THE CUP AT THIS POINT. THE LINER WAS REMOVED FROM THE CUP WITH THE ASSISTANCE OF AN OSTEOTOME. CUP WAS REMOVED WITH RELATIVE EASE WITH THE EXTRACTOR LEAVING NO SIGNIFICANT BONE LOSS. WE ATTEMPTED TO PLACE A METAPHLSEAL FITTING STEM INTO T

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Pain; Scar Tissue

  MAUDE report 20343072 ↗
• InjuryJul 16, 2024Migration; Migration

  APPROXIMATELY 12 DAYS AFTER LEFT THA, THE PATIENT WAS REVISED DUE TO SUBSIDENCE AND A LESSER TROCHANTER FRACTURE. THE STEM AND CERAMIC BALL WERE REVISED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT CAUSE A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19754951 ↗
• InjuryOct 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2017, WAS BROUGHT BACK FOR RIGHT HIP PAIN AND WAS REVISED ON (B)(6) 2022, APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE FEMUR WAS DISLOCATED, THE FEMORAL HEAD REMOVED. THE STEM WAS CHECKED AND FOUND TO BE LOOSE AND REMOVED. ATTENTION TURNED TO THE CUP, THE POLY WAS REMOVED WITH THE HELP OF A CHISEL. THE CUP WAS CHECKED AND FOUND TO BE WELL FIXED. A NEW LINER WAS IMPLANTED. ATTENTION TURNED BACK TO FEMUR WHERE A SIZE 8 ALTEON HPS STEM WAS IMPLANTED ALONG WITH A NEW BIOLOX HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Implant Pain

  MAUDE report 15540805 ↗
• InjuryAug 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS FEMALE PATIENT HAD A RIGHT SIDE THA ON (B)(6) 2017. THE PATIENT WAS BROUGHT BACK FOR RIGHT HIP PAIN. THE HIP WAS DISLOCATED, THE FEMORAL HEAD REMOVED. THE STEM WAS CHECKED, FOUND TO BE LOOSE AND REMOVED. ATTENTION TURNED TO CUP. THE LINER WAS REMOVED WITH THE USE OF A BONE SCREW. THE CUP WAS CHECKED, FOUND TO BE WELL FIXED. A NEW G1 32 LIP XLE LINER WAS IMPLANTED. ATTENTION TURNED BACK TO THE FEMUR WHERE A NEW SIZE 6 STD OFFSET HPS STEM WAS CEMENTED IN PLACE ALONG WITH A NEW 32 +3.5 BIOLOX HEAD. THERE IS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT RETURNING AS THE PATIENT REQUESTED THEM.

  Patient problems: Aseptic loosening; Failure of Implant; Implant Pain

  MAUDE report 15174811 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162732. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2018 · Oct 9, 2017 · Terminated
  Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals underg