Novation 186-01-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862038753), received between Mar 23, 2020 and Apr 23, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 7 YEARS AND 4 MONTHS AGO. THE PATIENT STARTED HAVING PAIN AND SQUEAKING, SO THE SURGEON REVISED THE LINER AND HEAD. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21890771 ↗
• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 115 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ACETABULAR CUP LOOSENING, POLYETHYLENE INDUCED SYNOVITIS, AND PROXIMAL FEMORAL OSTEOLYSIS. PATIENT WAS ALSO INDICATED FOR INCREASING PAIN IN THE RIGHT HIP. INITIAL SURGERY AND 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022 X-RAY: NO. OPERATIVE NOTES: YES.

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

  MAUDE report 21264119 ↗
• InjuryMar 8, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YRS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT WAS REVISED DUE TO THE GXL POLY WORE OUT AND THE FEMORAL HEAD STARTED TO WEAR OUT THE INTERGRIP SHELL. THE CUP AND LINER WERE REMOVED. THE HEAD WAS REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY DOESN'T ALLOW EXPLANTS TO BE REMOVED FROM THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 11438913 ↗
• InjuryOct 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O FEMALE WAS INITIALLY IMPLANTED ON (B)(6) 2018. AT FOLLOW UP ON (B)(6) 2018 IN THE OFFICE. THE SURGEON NOTICED AN AREA THAT WAS NOT AGAINST BONE. HE FOLLOWED IT FOR COUPLE YEARS. EACH TIME IT CONTINUED TO MOVE AND SHOW MORE LOOSENING. APPROXIMATELY 2 YRS POSTOP THE INITIAL IMPLANT, THE SURGEON REVISED TO A COMPETITOR¿S REVISION MULTI HOLE CLUSTER CUP WITH A +10 LATERALIZED LINER AND THEN USED A +7 BIOLOX HEAD. DEVICES WILL NOT RETURN AS THE SURGEON KEPT THEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10696377 ↗
• InjuryMar 23, 2020Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP THE INITIAL LEFT THA, THIS PATIENT WAS REVISED DUE TO TANTALUM PARTICULATE DEBRIS THIRD BODY WEAR OF GXL POLY. THIS (B)(6)Y/O (B)(6)LB, 5¿3¿ FEMALE HAS A HISTORY OF AVASCULAR NECROSIS, HYPERTENSION, AND LUPUS. DEVICES WILL NOT RETURN. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9868088 ↗