Novation 186-01-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862038784), received between Jun 11, 2024 and Jan 3, 2025 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2014 DUE TO SEVERE OSTEOARTHRITIS. APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2022. PATIENT EXPERIENCED OSTEOLYSIS, SYNOVITIS, FAILURE OF IMPLANT AND PAIN. REVISION OP REPORT NOTED THAT THE ACETABULAR COMPONENT WAS PARTIALLY LOOSE, POSITIONED IN 50 DEGREES OF ABDUCTION AND 5 TO 10 DEGREES OF ANTEVERSION, THERE WAS EVIDENCE OF WEAR OF THE POLY LINER. THERE WAS BONE LOSS IN THE ACETABULUM PAPROSKY IIA WITH OSTEOLYSIS IN THE ILIUM AND PUBIC BONE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION AFTER REVERSAL OF ANESTHESIA. 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.

  Patient problems: Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21072609 ↗
• InjuryDec 27, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024. THE CUP WAS REVISED TO A COMPETITOR¿S DEVICE AND THE FEMORAL HEAD BALLS WERE REVISED DUE TO PAIN. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. REASON UNKNOWN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 21029671 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP WAS DISLOCATED POSTERIOR. STEM WAS STABLE AND WELL FIXED. ABDUCTORS WERE MINIMAL DAMAGE, 20% DAMAGE FROM OSTEOLYSIS. SIGNIFICANT AMOUNT OF DENSE SCAR TISSUE WAS RESECTED FROM THE AROUND THE HIP JOINT. POLY LINER FROM CUP USING DRILL SCREW TECHNIQUE. CUP OUT USED TO REMOVE THE CUP. IT WAS ELECTED TO PLACE A DUAL MOBILITY LINER. THE LINER WAS INSERTED INTO THE CUP AND IMPACTED. IT IS NOTED TO BE WELL SEATED AND LOCKED INTO POSITION. REAL HEAD IMPACTED ONTO THE STEM. HIP WAS REDUCED INTO THE CONSTRAINED CUP. IT WAS VERY STABLE AND DID NOT DISLOCATE OR IMPINGE WITH HIP FLEXION 90 DEGREES AND INTERNAL ROTATION TO 90 DEGREES. PATIENT WAS REVERSED FROM ANESTHESIA AND MOVED ONTO THE HOSPITAL BED WITHOUT DIFFICULTY. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION. CUP WAS REMOVED WITHOUT DIFFICULTY - MINIMAL BONE IN GROWTH. STEM WAS STABLE, WELL FIXED, AND WELL POSITIONED - THEREFORE KEPT THE STEM. VERY STABLE RECONSTRUCTION. MODERATE AMOUNT OF SOFT TISSUE CONSISTENT WITH OSTEOLYSIS. MODERATE AMOUNT OF ACETABULAR BONE DAMAGE DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis; Pain

  MAUDE report 20290514 ↗
• InjuryJun 11, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT HAD AND INITIAL RIGHT TOTAL HIP ARTHROPLASTY THEN APPROXIMATELY 7 YEARS, 8 MONTHS LATER THEY EXPERIENCED A REVISION SURGICAL PROCEDURE. REVISION OPERATIVE REPORT- POSTOPERATIVE DIAGNOSIS: MECHANICAL FAILURE OF RIGHT TOTAL HIP WITH ACETABULAR FAILURE. INDICATIONS: LOOSE CUP AFTER POLY WEAR. FINDINGS: LOOSE CUP. PROCEDURE: CAPSULOTOMY WAS PERFORMED REVEALING A FAIR AMOUNT OF FLUID, WHICH WAS SENT FOR CULTURES. DISLOCATED THE HIP AND REMOVED THE HEAD BALL, STEM WAS NOTED TO BE INTACT IN GOOD FIXATION AND OPTED FOR PRESERVATION OF STEM. ¿ONE SCREW WAS REMOVED AND CUP WAS REMOVED WITHOUT DIFFICULTY WITH MINIMAL TO THE BONE.¿ NEW DEVICES IMPLANTED. DRESSINGS APPLIED, THEN THE PATIENT WAS TAKEN TO RECOVERY ROOM WITHOUT INCIDENT. 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.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 19508915 ↗