Exactech 170-32-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862153623), received between Apr 7, 2023 and Jul 2, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE LEGAL BRIEF THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY, OSTEOLYSIS, AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19656695 ↗
• InjuryApr 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 62 Y/O FEMALE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF THEIR RIGHT REVISED HIP. THE SURGEON'S OFFICE REPORT MENTIONS SOME MEDIAL HEALING OF THE MEDIAL WALL FRACTURE, HOWEVER HE IS CONCERNED ABOUT LOOSENING OF THE ACETABULAR IMPLANT. A REVIEW OF THE BONE SCAN SHOWED INCREASED UPTAKE AROUND THE HIP IMPLANT. THE PATIENT WAS SCHEDULED FOR MORE TESTING TO EVALUATE THE REMAINING BONE STOCK FOR CHOICE OR REVISION IMPLANT OPTIONS. THE PATIENT WAS BOOKED FOR A SECOND REVISION RIGHT THA ON (B)(6) 2023. THIS REVISION INVOLVED THE EXACTECH STEM AND 28MM HEAD. DURING THE REVISION, THE ACETABULAR COMPONENTS WERE REMOVED AND THE STEM AND HEAD WERE REMOVED. A REVISION ALTEON MONOBLOCK IMPLANT AND 28MM HEAD WERE REIMPLANTED ON THE FEMORAL SIDE. DJO WAS RE-IMPLANTED ON THE ACETABULAR SIDE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, THE IMPLANTS WERE SAVED FOR LAB AND LEGAL AT THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 16700469 ↗