Alteon 190-31-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862320971), received between Mar 26, 2022 and Jul 14, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Implant subsidence; Adverse Event Without Identified Device or Use Problem; Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED HIP PAIN. POSSIBLE STEM SUBSIDENCE WAS NOTED AT 22 MONTHS, AND AT 23 MONTHS THE HIP WAS ASPIRATED. THERE WAS NO FOLLOW UP AFTER. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22494025 ↗
• InjurySep 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  12-SEP-2024 ADDITONAL SUMMARY*** IT IS REPORTED VIA LEGAL DOCUMENTATION THAT PATIENT IS VERIFIED LEFT HIP ON (B)(6) 2018 AT (B)(6) MEDICAL CENTER AND PATIENT HAD REVISION LEFT HIP ON (B)(6) 2024. PRE/POST OP REPORT: OTHER MECHANICAL COMPLICATION OF INTERNAL LEFT HIP PROSTHESIS, INITIAL ENCOUNTER. PROCEDURE: LEFT TOTAL HIP REVISION. INDICATIONS FOR SURGERY: (B)(6) IS A 60 YEAR-OLD MALE WHO IS HAVING SURGERY FOR OTHER MECHANICAL COMPLICATION OF LEFT HIP PROTHESIS, INITIAL ENCOUNTER. OP NOTES: UPON ENTERING THE PROSTHETIC JOINT THERE WAS SOME CLEAR FLUID PRESENT. THERE WERE NO SIGNS OF ANY DEEP PURULENCE. THE PROXIMAL PORTION OF THE FEMUR WAS THEN EXPOSED AND AN EXTRACTION DEVICE WAS CONNECTED TO THE STEM. WITH 2 TAPS THE ENTIRE STEM CAME OUT AND WAS GROSSLY LOOSE. I THEN DEBRIDED ALL OF THE FIBROUS TISSUE AND THE POLYETHYLENE WEAR DEBRIS THAT WAS IN THE PROXIMAL FEMUR. THE POLYETHYLENE LINER WAS REMOVED THERE WAS SIGNIFICANT EVIDENCE OF ACCELERATED POLYETHYLENE WEAR AT THE SUPERIOR PORTION OF THE POLY. I THEN TOOK OUT THE 1 ACETABULAR SCREW WHICH HAD ABSOLUTELY NO PURCHASE AND EVALUATED THE CUP. WHEN EVALUATING THE CUP, I GOT WORRIED THAT I MIGHT HAVE DAMAGED THE MECHANISM FOR THE PO

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251178 ↗
• MalfunctionMar 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE MALE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2019. THE PATIENT WAS BROUGHT BACK FOR LEFT HIP PAIN AND THE X-RAYS SHOWED A LOOSE STEM. THE FEMUR WAS DISLOCATED AND THE FEMORAL HEAD REMOVED. THE STEM WAS CHECKED AND FOUND TO BE LOOSE AND SUBSIDED. IT HAD FIXATION DISTALLY, BUT NOT PROXIMALLY. OSTEOTOMES AND A HIGH SPEED BURR WERE USED TO HELP GET THE STEM OUT. THE STEM IS PRETTY BANGED UP. THE STEM WAS REMOVED WITH THE HELP OF A SLAP HAMMER. ATTENTION TURNED TO THE CUP. THE LINER WAS REMOVED WITH THE HELP OF A SCREW. A NEW G2 LIPPED XLE LINER WAS IMPLANTED. A 19 X 245 MONOBLOC STEM WAS IMPLANTED WITH A 36 +0 HEAD. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16651882 ↗
• InjuryJan 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY DUE TO SEVERE OSTEOARTHRITIS IN HIS LEFT HIP. FOLLOWING THE LEFT HIP ARTHROPLASTY, PATIENT PRESENTED TO SURGEON COMPLAINING OF LEFT SIDED HIP PAIN. AN X-RAY EXAMINATION OF PATIENT'S LEFT HIP WAS ORDERED AND SHOWED A LUCENT LINE ABOUT THE FEMORAL STEM OF THE LEFT DEVICE. IMPORTANTLY, SURGEON NOTED THAT PATIENT'S LEFT FEMORAL STEM WAS "GROSSLY LOOSE." ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT LEFT HIP REVISION SURGERY DUE TO ASEPTIC LOOSENING AND A FAILED LEFT TOTAL HIP ARTHROPLASTY. SURGEON SPECIFICALLY NOTED IN THE REVISION OPERATIVE REPORT THAT "THE STABILITY OF THE [FEMORAL] STEM WAS CHECKED AND FOUND TO BE LOOSE".

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

  MAUDE report 16183945 ↗
• InjuryMar 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT THA, THIS MALE PATIENT WAS BROUGHT BACK FOR LEFT HIP PAIN. X RAYS SHOWED SIGNS OF POTENTIAL LOOSENING OF THE STEM. THE HEAD WAS REMOVED. THE STEM WAS CHECKED AND FOUND TO BE LOOSE. THE STEM WAS REMOVED. ATTENTION TAKEN TO THE ACETABULAR COMPONENT. THE POLY LINER WAS REMOVED WITH USE OF A 45MM 6.5 BONE SCREW. THE CUP WAS CHECKED AND FOUND TO BE WELL FIXED. A NEW G2 LIPPED 36MM XLE LINER WAS IMPLANTED. A 21X245 STEM WAS IMPLANTED WITH A 36+7 BIOLOX HEAD. THERE WERE NO PARTS OR PIECES FALL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13922529 ↗

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