Novation 164-01-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862035097), received between Aug 18, 2020 and Feb 26, 2026 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K080980); they may or may not involve this specific model.

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

• InjuryFeb 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A 42 YO PATIENT, WHO HAD THA¿S ON BOTH HIPS ON DIFFERENT DATES, UNDERWENT A REVISION PROCEDURE ON THE LEFT HIP APPROXIMATELY 1 YEAR 9 MONTHS POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THERE WAS NOTIFICATION OF WEAR AND TEAR AND COMPREHENSIVE FOLLOW-UP FOR PATIENTS TREATED SURGICALLY AND EXPERIENCING PROBLEMS WITH THE IMPLANTED MATERIALS. HOSPITALIZATION REQUIRED, NEED FOR INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY, PHYSICAL, EMOTIONAL, SOCIAL, AND WORK-RELATED IMPACT WAS ALSO REPORTED. THE REPORT STATED THE ACETABULAR COMPONENT IN BOTH HIPS REMAINS IMPLANTED. NO DEVICE IMAGES OR X-RAYS WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24464409 ↗
• InjurySep 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 135 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE PAIN; SEVERE OSTEOLYSIS, EXCESSIVE SOFT TISSUE DEBRIS CONSISTENT WITH SYNOVITIS, GROSSLY LOOSE FEMORAL STEM, LOOSE CUP, EXCESSIVE POLYETHYLENE WEAR ON LINER WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION . 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.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 20170301 ↗
• InjuryJul 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 12 YEARS 7 MONTHS AFTER RIGHT PRIMARY TOTAL HIP REPLACEMENT, THE PATIENT RETURNED COMPLAINING OF PAIN AND DISSATISFACTION WITH THEIR LEFT PRIMARY HIP. THE POLY AND A RECALLED IMPLANT WERE WORN UPON EXAMINATION AND IMAGING. THE PATIENT UNDERWENT REVISION LEFT THA ON (B)(6) 2024 WHERE THE STEM, HEAD, AND LINER WERE REMOVED. A NEW LINER WAS IMPLANTED INTO THE CUP AND A DIFFERENT COMPANY (STRYKER) STEM AND THE HEAD WAS IMPLANTED INTO THE FEMORAL SIDE. THIS EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL PROLONGATION/DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: IMPLANTS ARE SENT TO THE LAB AND LEGAL. NOT GIVEN TO THE REPRESENTATIVE. UNABLE TO OBTAIN IMAGES OF EXPLANTS OR X-RAYS. IMAGES & EBI ATTACHED.

  Patient problems: Pain

  MAUDE report 19776382 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 4.5 YEARS POSTOP THE INITIAL THA, THIS FEMALE PATIENT HAD BEEN DISLOCATING THE RIGHT HIP AND THE SURGEON FELT THE STEM WAS TOO ANTEVERTED. THE LINER WAS REMOVED AND REPLACED WITH A HOODED LINER AND THE FEMORAL HEAD WAS EXCHANGED FOR A COMPETITOR¿S HEAD (MODULAR HEAD SYSTEM ALLOWING VERSION ADJUSTMENTS). PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO REP NOT PRESENT DUE TO COVID POLICY.

  Patient problems: Joint Dislocation

  MAUDE report 10419834 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080980. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2016 · Sep 23, 2015 · Terminated
  Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation