Exactech 170-36-93Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862155481), received between Apr 11, 2022 and Nov 19, 2024 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REPLACEMENT AND HAD SURGERY DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20730377 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2016. THE PATIENT DEVELOPED AN EARLY DEEP PERIPROSTHETIC INFECTION. AN EXCISIONAL ARTHROPLASTY OF HIS HIP WITH REMOVAL OF THE TOTAL HIP REPLACEMENT AND INSERTION OF AN ANTIBIOTIC ARTICULATING SPACER. 6 WEEKS OF IV ANTIBIOTICS. 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) 2016: DIAGNOSIS: HISTORY OF INFECTED TOTAL RIGHT HIP: FINDINGS: 1. INTRAOPERATIVE FINDINGS SHOWED NO GROSS EVIDENCE OF INFECTION 2. INTRAOPERATIVE FROZEN SECTIONS OF THE WORST-APPEARING TISSUE IN THE PERIACETABULAR REGIONS SHOWED NO EVIDENCE OF ACUTE INFLAMMATION. THERE WAS MILD TO MODERATE CONTAINED BONE LOSS OF THE PROXIMAL FEMUR AND ACETABULUM. THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION, HAVING TOLERATED THE PROCEDURE WELL.

  Patient problems: Unspecified Infection

  MAUDE report 18100128 ↗
• InjuryApr 19, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 89 YO MALE PATIENT SUFFERED A DISLOCATION DUE TO A FAILED LEFT TKA SECONDARY TO INSTABILITY, RESULTING IN REVISION LEFT THA OF FEMORAL HEAD BALL AND ACETABULAR LINER. THE PATIENT WAS REVISED ON (B)(6) 2019.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 16769642 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INVESTIGATION OF A LEGAL CASE, A SECOND REVISION WAS FOUND. A FEMALE PATIENT, WHO HAD A LEFT HIP REVISION ON (B)(6) 2019, UNDERWENT A REVISION ON (B)(6) 2019, FOR UNKNOWN REASONS. THE FEMORAL HEAD WAS REVISED. NO FURTHER INFORMATION KNOWN. FIRST REVISION REPORTED UNDER 1038671-2022-01027.

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

  MAUDE report 15635861 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ONE MONTHS POST INITIAL LEFT THA, THIS (B)(6) MALE PATIENT HAD A PERIPROSTHETIC HIP FRACTURE. IT IS UNKNOWN HOW IT HAPPENED. PATIENT WAS REVISED TO AN ALTEON MONOBLOC STEM AND BIOLOX DELTA HEAD WERE IMPLANTED. THERE WAS NO BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 14074446 ↗