Novation 164-01-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862035127), received between May 14, 2026 and Aug 31, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Report #2 of 2 for this event.As reported via legal documentation this patient had a right total hip arthroplasty. Subsequently, five (5) years, four (4) months later the patient underwent a revision procedure due to prosthesis wear. A revision operative report was provided. Intraoperatively, the femoral stem was determined to be loose. The patient tolerated the procedure well. No further information is available.

  Patient problems: Insufficient Information

  MAUDE report 50532344 ↗
• InjuryMay 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A LEFT HIP REPLACEMENT. THE PATIENT LATER RETURNED TO THE PHYSICIAN¿S OFFICE WITH COMPLAINTS OF PAIN, STIFFNESS, DECREASED RANGE OF MOTION, INSTABILITY, AND DISSATISFACTION RELATED TO THEIR LEFT TOTAL HIP ARTHROPLASTY (THA). EVALUATION REVEALED THE PRESENCE OF A RECALLED GXL LINER, A MALPOSITIONED ACETABULAR CUP, ASSOCIATED BONE LOSS, AND FEMORAL COMPONENT LOOSENING. ALSO, PHOTOGRAPHS PROVIDED SHOW WEAR ON THE LINER. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY. THE PROCEDURE INVOLVED EXPLANTATION OF ALL EXISTING HIP COMPONENTS. DUE TO THE EXTENT OF BONE LOSS, ADDITIONAL BONE GRAFT SUBSTITUTE WAS REQUIRED. A REVISION LOCKING ACETABULAR CUP WAS IMPLANTED WITH A NEW ACETABULAR LINER, AND THE FEMORAL COMPONENT WAS REVISED WITH PLACEMENT OF A MONOBLOCK REVISION STEM. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 25174429 ↗

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