Novation 160-01-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862031808), received between Sep 7, 2021 and Jul 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 20, 2023Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2014 DUE TO PAINFUL END STAGE ARTHRITIS OF LEFT HIP. APPROXIMATELY 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2015. REVISION OP REPORT NOTED THAT THE PATIENT'S TOTAL HIP ARTHROPLASTY WAS COMPLICATED BY A FRACTURE OF THE FEMORAL SHAFT WHICH ESSENTIALLY HEALED IN A MALUNION WITH SUBSIDENCE OF THE STEM AND OBVIOUS LOOSENING TO THE ACETABULUM. THE SURGEON NOTED THAT THE STEM WAS GROSSLY UNSTABLE, HOWEVER, THEY DID NOT SEE ANY ACTUAL FAILURE OF THE STEM SUCH AS A FRACTURE. THERE WERE MULTIPLE SCUFFS WITH THE POLYETHYLENE, WHICH WAS REMOVED. INSPECTION OF THE PATIENT'S FEMUR DID NOT FIND ANY INSTABILITY WITH PALPATION OF THE GREATER TROCHANTER, NOR ANY DEFINITE ACUTE FRACTURE LINES. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS FRACTURE WHICH APPEARED TO BE HEALED ON X-RAYS. HOWEVER, THERE WAS WIDENING IN THE METAPHYSEAL REGION. THE FRACTURE HAD BEEN LOW, ALMOST EXITING NEAR THE TIP OF THE STEM; IT WAS JUST PROXIMAL TO THE TIP OF THE STEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Joint Laxity; Malunion of Bone; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17364023 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH HIP REPLACEMENT CLINICAL STUDY, APPROXIMATELY FIVE-YEAR POST THA, THE PATIENT EXPERIENCED MECHANICAL FALL, THE MID SHAFT FEMUR FX LEFT ORIF. PATIENT HAD LABS REPAIRING SURGICAL PROCEDURE TWO DAYS LATER. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 12433045 ↗