Novation 132-32-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862023339), received between Aug 10, 2022 and Dec 18, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1729-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2133-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A MALE PATIENT, WHO HAD AN INITIAL RIGHT HIP IMPLANTED ON (B)(6), 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2023, APPROXIMATELY 9 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS BROUGHT BACK FOR RIGHT HIP PAIN. DURING THE PROCEDURE, THE FEMUR WAS DISLOCATED, AND THE FEMORAL HEAD REMOVED. THE STEM WAS CHECKED AND FOUND TO BE WELL FIXED. ATTENTION TURNED TO THE CUP. THE LINER WAS REMOVED WITH THE HELP OF A BONE SCREW. ALL THREE SCREWS WERE REMOVED, AND THE CUP WAS FOUND TO BE LOOSE AND REMOVED. FEMORAL HEAD ALLOGRAFT WAS IMPACTED INTO THE ACETABULUM WITH BONE GRAFT. A NEW COMPETITOR¿S DUAL MOBILITY CUP WAS THEN IMPLANTED ALONG WITH A NEW FEMORAL HEAD. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. AN X-RAY WAS PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ARE AVAILABLE. THE PATIENT REQUESTED TO KEEP THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Pain

  MAUDE report 18346649 ↗
• InjuryJul 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 2 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON 22 JUN 2023. DIAGNOSIS: SEVERE OSTEOLYSIS FEMORAL AND ACETABULAR COMPONENTS THE PROXIMAL FEMUR WAS EVALUATED THERE WAS EXTENSIVE OSTEOLYSIS THE TROCHANTER WAS MODESTLY MOBILE. THE ENTIRE ACETABULAR COMPONENT SUPERIORLY THERE WAS A SIGNIFICANT LOSS OF BONE DUE TO OSTEOLYSIS AS THERE WAS INFERIORLY. THE PATIENT WAS AWAKENED TRANSPORTED TO THE RECOVERY ROOM THERE WERE NO COMPLICATIONS TO THE PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17389609 ↗
• InjuryAug 10, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST INITIAL LEFT THA, SURGEON MADE DECISION TO REVISE HIP DUE TO PATIENT DISLOCATING POSTERIORLY MULTIPLE TIMES. PATIENT HAD A 60MM NOVATION CROWN CUP CLUSTER-HOLE SHELL GROUP, A NOVATION LIPPED LINER GROUP 4 32MM, AND A 32MM +0 COCR HEAD ON A SIZE 10 NOVATION ELEMENT HA COATED PRESS FIT STEM. SURGEON REVISED PATIENT VIA POLY SWAP BY GOING POSTERIOR APPROACH AND FOUND THE LIPPED LINER FACED ANTERIOR. SURGEON OBSERVED THAT THERE WAS SOME ADVANCED WEAR WITHIN THE POLY AND THE HEAD APPEARED TO BE MOVING AROUND WITHIN THE POLY ABNORMALLY AS IT WASN'T HELD WITHIN THE LINER AS NORMAL. SURGEON REMOVED LINER AND REMOVED HEAD. SURGEON SWITCHED TO A CERAMIC 36 OPTION HEAD WITH A +3.5 SLEEVE AND WENT WITH A NOVATION XLE 10 DEGREE FACE CHANGING LINER GROUP 4 36MM.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 15198652 ↗