Novation 186-01-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862038807), received between Nov 2, 2021 and Sep 25, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Loss of Osseointegration

  It was reported that the patient underwent an initial left total hip arthroplasty. Subsequently, it was reported that the patient experienced pain, osteolysis, prosthesis wear and acetabular loosening. As a result, the patient underwent a left hip revision approximately 7 years after initial implantation. Patient was last known to be in stable condition. No further information available.

  Patient problems: Aseptic loosening; Osteolysis; Pain

  MAUDE report 50897461 ↗
• InjuryJul 9, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT THA, THE 71 Y/O MALE PATIENT PRESENTED WITH COMPLAINTS OF PAIN AND DISSATISFACTION WITH THEIR PRIMARY EXACTECH HIP. THE PATIENT HAD A RECALL GXL POLY LINER AND WAS BOOKED FOR REVISION SURGERY. THE PATIENT UNDERWENT TOTAL ACETABULAR REVISION TO A EXACTECH 28MM COCR +10MM HEAD AND COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 30-45 MINS SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE PRODUCTS WERE SENT TO THE LAB AT THE HOSPITAL.

  Patient problems: Osteolysis; Pain

  MAUDE report 22456864 ↗
• InjuryMay 27, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION AND THE SURGEON REMOVED THE HEAD AND THEN THE LINER, WHICH WAS IN PIECES. HE THEN IMPLANTED A NEW G3 XLE LINER AND A 40+7 BIOLOX OPTIONS HEAD. 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. ADDITIONAL INFORMATION RECEIVED VIA LEGAL NOTIFICATION NOTED THAT THE PATIENT HAD CATASTROPHIC FAILURE OF THEIR POLYETHYLENE WEAR. AFTER A THOROUGH HISTORY, PHYSICAL AND RADIOGRAPHIC EXAMINATION, THE PATIENT WAS DIAGNOSED WITH A FAILED RIGHT TOTAL HIP ARTHROPLASTY. DURING REVISION, COPIOUS AMOUNTS OF ANTERIOR HIP SCARRING WAS ENCOUNTERED. THE HIP WAS ASPIRATED. DARK GRAY/BLACK FLUID WAS OBTAINED, CONSISTENT WITH MELANOSIS. THIS WAS SENT TO THE LABORATORY. AN ANTERIOR HIP ARTHROTOMY WAS THEN PERFORMED IN THE USUAL FASHION. SOFT TISSUE DEBRIDEMENT WAS PERFORMED THROUGHOUT. COPIOUS AMOUNTS OF ADDITIONAL DARK GRAY/BLACK-APPEARING FLUID WAS OBTAINED AND THOROUGHLY DEBRIDED. IMMEDIATELY UPON ENTERING THE HIP JOINT THROUGH THE ANTERIOR HIP CAPSULE, FRAGMENTED POLYETHYLENE WAS READI

  Patient problems: Metal Related Pathology

  MAUDE report 22090089 ↗
• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, CLICKING, SWELLING, GAIT IMPAIRMENT, POOR BALANCE, BONE LOSS, AND BONE DAMAGE. THE PATIENT ADDITIONALLY REPORTED EMOTIONAL DISTRESS. DURING THE PROCEDURE A LARGE OSTEOLYTIC CYST WAS FOUND, INCLUDING SYNOVITIS. 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-1729-2022 X-RAY: NO. OPERATIVE NOTES: NO.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Cyst(s); Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21265129 ↗
• InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21230069 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED POST-OP VIA CLINICAL STUDY THAT THE 46 YO MALE EXPERIENCED A LATE HEMATOGENOUS PROSTHETIC JOINT INFECTION THAT POSSIBLY DEVELOPED FROM AN UPPER RESPIRATORY INFECTION, THAT SPREAD THROUGH THE BLOOD STREAM. THE EVENT RESULTED IN A TWO-STAGE REVISION, INCLUDING A TEMPORARY SPACER AND ANTIBIOTIC TREATMENT FOLLOWED BY A SECOND REVISION TO A FINAL IMPLANT. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6)2021.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 16770255 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 14 MONTHS POSTOP THE INITIAL LTHA, THE (B)(6) MALE PATIENT HAD A REVISION OF AN EXACTECH HIP, LINER AND CUP, DUE TO PATIENT COMPLAINING OF PAIN AT SITE. PATIENT WAS REVISED TO A ZIMMER TM CUP AND TRILOGY LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION, DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12741234 ↗