Novation 164-01-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862035110), received between Nov 5, 2019 and Jul 21, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY 10 YEARS AND 11 MONTHS POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO LOOSENING AND SUBSIDENCE. THE STEM WAS REMOVED. 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.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 22557111 ↗
• InjuryFeb 11, 2025Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, ANXIETY, DISTRESS, IMPLANT PAIN, LOSS OF RANGE OF MOTION, AND OSTEOLYSIS. 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.

  Patient problems: Anxiety; Distress; Implant Pain; Loss of Range of Motion; Osteolysis

  MAUDE report 21357506 ↗
• InjuryJan 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 77 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAROSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL) COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS. ADDITIONALLY, INCREASED SHELF OXIDATION RESULTING FROM THE USE OF NYLON VACUUM BAGS WITHOUT EVOH COULD ALSO HAVE CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 21252857 ↗
• InjurySep 11, 2024Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL SHORT FORM NOTIFICATION, THAT APPROXIMATELY 103 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LOSS OF RANGE OF MOTION, DIFFICULTY AMBULATING, OSTEOLYSIS, DEGRADATION OF HIP PROTHESIS, DISINTEGRATION OF LINER, AND PROBABLE STEM LOOSENING. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Loss of Range of Motion; Osteolysis

  MAUDE report 20196293 ↗
• InjuryNov 5, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO PROXIMAL FRACTURE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9279442 ↗

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