Novation 186-01-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862038760), received between Nov 5, 2019 and Apr 29, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Loss of Osseointegration

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL LEFT SIDE THA, THE 75 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY LINER AND ACETABULAR CUP FAILURE. THE HEAD, LINER, CUP, AND SCREW WERE REMOVED. ACCORDING TO THE SURGEON, THE PATIENT HAD SIGNIFICANT ACETABULAR BONE LOSS FROM OSTEOLYSIS DUE TO THE POLY DEBRIS FOUND WITHIN THE JOINT. THE CUP IMPLANT WAS LOOSE. THE PATIENT REQUIRED A MULTI-HOLE CAGED ACETABULAR IMPLANT FROM COMPETITORS TO REPLACE THEIR ACETABULUM AT THAT TIME. A MULTI-HOLE CAGE IMPLANT WITH SCREWS WAS PLACED AND A LINER WAS PLACED WITHIN THAT. THE HEAD WAS REPLACED WITH THE -3.5 SLEEVE ADAPTOR AND 28MM HEAD FROM EXACTECH. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR PHOTOS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL PATIENT INFORMATION PROVIDED. THE SURGEON REPORTED THAT AT THE INITIAL REVISION SURGERY THE LINER WAS IN PIECES, IT SHOWED SIGNIFICANT WEAR. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 25033119 ↗
• InjuryFeb 16, 2026Naturally Worn

  AS REPORTED, THIS PATIENT HAD A THA. THE PATIENT EXPERIENCED COMPLICATIONS, INCLUDING BUT NOT LIMITED TO SEVERE PAIN, DIFFICULTY IN WALKING, METALLOSIS, AND A FRACTURED LINER. THE PATIENT THEN UNDERWENT A REVISION SURGERY, APPROXIMATELY 4 YEARS, 8 MONTHS, AFTER INITIAL IMPLANT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain

  MAUDE report 24349444 ↗
• InjuryMay 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT THA, SURGEON PREFORMED AT RTHA AND DISCOVERED THAT THE NOVATION INTEGRIP CC CLUSTER SHELL IN HIS OPINION HAD NOT ACHIEVED PROPER FIXATION. A COMPETITOR'S CUP AND LINER WERE USED AS REPLACEMENT. HOWEVER, AN EXACTECH CHROME COBALT HEAD WAS USED TO REPLACE THE ORIGINAL HEAD IMPLANT. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE PRODUCT THAT WAS REMOVED WAS DISCARDED WITH BIOHAZARDS MATERIAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16843589 ↗
• InjuryNov 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O MALE PATIENT HAD A REVISION DUE TO THA MASSIVE OSTEOLYSIS LOOSENING. DATE OF INITIAL IMPLANT IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 12733946 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6 YRS POSTOP INITIAL RTHA, THIS 75 Y/O MALE PATIENT IS FOUND TO HAVE OSTEOLYSIS AND HAS NOT BEEN REVISED AT THIS POINT. THE PATIENT HAS BEEN REFERRED FOR POSSIBLE REVISION.

  Patient problems: Osteolysis

  MAUDE report 12338754 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 19 MONTHS POSTOP THE INITIAL RIGHT HIP THA, THIS (B)(6) Y/O FEMALE PATIENT HAD A TOTAL HIP PROSTHESIS REMOVED AND REVISED DUE TO INFECTION. THE PATIENT WAS REVISED TO A COMPETITOR¿S COMPONENTS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL KEPT THE DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11454272 ↗
• InjuryFeb 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS POSTOP THE INITIAL RIGHT THA, THE (B)(6) Y/O FEMALE PATIENT WAS HAVING HER RIGHT FEMORAL HEAD AND POLY EXCHANGED. THE PATIENT WAS HAVING GROIN PAIN. THE HIP WAS DISLOCATED, AND THE FEMORAL HEAD WAS REMOVED. THE STEM WAS CHECKED AND FOUND TO BE WELL FIXED. ATTENTION WAS TURNED TO THE ACETABULAR COMPONENT. DURING ATTEMPTED REMOVAL OF THE POLY LINER, THE CUP WAS FOUND TO BE LOOSE AND WAS REMOVED. THE PATIENT RECEIVED A NEW CUP, A NEW EXTENDED COVERAGE LINER, AND FEMORAL HEAD WITH A +7 SLEEVE. A 15-30-MINUTE DELAY WAS CAUSED; HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11374543 ↗
• InjuryNov 5, 2019Defective Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX SURGERY: (B)(6) 2014. THE PATIENT CALLED EXACTECH ASKING IF THERE WAS A RECALL ON HER IMPLANTED DEVICES. SHE IS PENDING A REVISION ON (B)(6) BECAUSE HER CUP OR LINER HAS GONE BAD. UPDATE: (B)(6) 2020: PATIENT WAS REVISED ON (B)(6) 2019 DUE TO REASON NOT REPORTED. CONCOMITANT DEVICES: BIOLOX DELTA FEMORAL HEAD 28MM OD, -3.5MM (CN: 170-28-93; SN: (B)(6)) NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 (CN: 130-28-51; SN: (B)(6))

  Patient problems: No Code Available; No Information

  MAUDE report 9278727 ↗