Novation 180-01-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862037053), received between Jun 8, 2020 and Sep 16, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

16 other recalls cover devices cleared under the same FDA submission (K070479); 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.

• InjurySep 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED, A MALE PATIENT, WHO HAD AN INITIAL RIGHT HIP IMPLANTED, UNDERWENT A REVISION PROCEDURE 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.

  Patient problems: Implant Pain

  MAUDE report 23069613 ↗
• InjuryMay 5, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD HIP PROCEDURE, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT PRESENTED FOR A FOLLOW-UP IN 2023. X-RAYS AND CT SCANS REVEALED MODERATE DECENTRATION OF THE PROSTHETIC HEAD AND OSTEOLYSIS IN THE ACETABULUM, INDICATING INLAY WEAR. DUE TO THE PATIENT'S COMORBIDITIES AND THE MINIMAL SIGNS OF WEAR, A WATCHFUL WAITING APPROACH WITH REGULAR FOLLOW-UP VISITS WAS AGREED UPON. WHEN SYMPTOMS SUDDENLY WORSENED SIGNIFICANTLY AT THE END OF 2024, A FURTHER FOLLOW-UP VISIT WAS CONDUCTED, WHICH REVEALED COMPLETE DISLOCATION OF THE CUP. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED, INCLUDING REPLACEMENT OF THE ENTIRE CUP (IMPLANTATION OF A REVISION CUP WITH ILIAC PEG FROM A COMPETITOR. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation; Osteolysis

  MAUDE report 21965199 ↗
• InjuryApr 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A PAINFUL LEFT HIP WITH OSTEOLYSIS. REVISION OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS INDICATED A FAILED LEFT HIP. THE SURGEON PERFORMED DEBRIDEMENT OF EXTENSIVE OSTEOLYSIS ON THE ACETABULUM AND TO SOME DEGREE ON THE FEMUR WITH RECONSTRUCTION OF THE ACETABULUM USING ALLOGRAFT AND BONE FILLER. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Pain; Scar Tissue

  MAUDE report 21930786 ↗
• InjuryOct 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT HIP REVISION ON (B)(6) 2023. THE PATIENT HAD EXTENSIVE SCARRING. THE PATIENT ENCOUNTERED A HUGE ADVERSE LOCAL TISSUE REACTION AND A LARGE FLUID COLLECTION AND A DARK GRAY TROCHANTERIC BURSITIS THAT HAD TO BE DEBRIDED. 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.

  Patient problems: Bone Fracture(s); Failure of Implant; Foreign Body Reaction; Joint effusion; Osteolysis; Scar Tissue

  MAUDE report 20360622 ↗
• InjuryJun 8, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DURING THE INVESTIGATION OF MFR 1038671-2020-00254 IT WAS DISCOVERED THAT THIS PATIENT HAD A REVISION OF EXACTECH DERIVES IN THE RIGHT HIP DUE TO LOOSENING AND INSTABILITY. INITIAL IMPLANT: (B)(6) 2007, REVISION : (B)(6) 2011. A SEARCH OF THE COMPLAINT SYSTEM DID NOT FIND A MATCH. THIS CASE FILE WAS OPENED TO CAPTURE THAT EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10129978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070479. One submission often covers many models, so check the product and lot details in each record.

• Z-1729-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRA
• Z-2127-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant
• Z-2118-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
• Z-2126-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner,
• Z-2132-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL a
• Z-2123-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
• Z-2128-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant
• Z-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
• Z-2117-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,
• Z-2122-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped A
• Z-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;
• Z-2120-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant
• Z-2116-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28m
• Z-2133-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
• Z-0788-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip r

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