Novation 186-01-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862038791), received between Jun 20, 2022 and Mar 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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

• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 59 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 21558493 ↗
• InjuryFeb 25, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL THA, THE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS AND POLY WEAR. THE POLY WAS IN SEVERAL PIECES. NO ISSUES WITH SURGERY.

  Patient problems: Osteolysis

  MAUDE report 21458550 ↗
• InjuryNov 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 95 MONTHS AFTER A TOTAL LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EXTENSIVE OSTEOLYSIS, SYNOVITIS, SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. 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; Pain; Synovitis

  MAUDE report 20705450 ↗
• InjuryJul 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2020. THE PATIENT HAD A REVISION OF THE CUP AND GXL LINER TO COMPETITOR DEVICES ON (B)(6) 2024; DUE TO A WORN GXL LINER/LOOSENING. THE STEM WAS RETAINED AND A NEW HEAD BALL WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19806886 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE FEMALE PATIENT HAD A LEFT HIP REVISION OF EXACTECH CUP. EXACTECH 36MM +10MM USED WITH EXISTING EXACTECH STEM. PATIENT WAS REVISED TO A COMPETITOR'S CUP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 14750737 ↗