Novation 180-01-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862037039), received between Mar 23, 2020 and Sep 8, 2026 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Loss of Osseointegration

  Report #2 of 2 for this event.As reported, due to the manufacturer's recall campaign, the patient that is five (5) years post-op the initial total hip arthroplasty, came in to have the hip prosthesis checked. Radiograph control revealed a clear decentering of the prosthetic head and unusually coarse osteolysis in the acetabulum as signs of premature inlay deterioration. The socket component was completely loosened. The patient was revised to another manufacturer's construct. No additional information is available.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 50669729 ↗
• InjuryAug 15, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS AND 5 MONTHS POST THE INITIAL THA, THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF THEIR LEFT HIP. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAD A RECALLED HIP LINER AND IT WAS SHOWN ON THE X-R AY TO HAVE WEAR AND FEMORAL HEAD MIGRATION WITHIN THE ACETABULAR IMPLANT. THE PATIENT WAS SCHEDULED FOR LEFT HIP REVISION POSSIBLE POLY LINER AND FEMORAL HEAD SWAP VS. FULL REVISION. THE PATIENT UNDERWENT LEFT HIP REVISION. DURING THE REVISION, THE PATIENT PRESENTED WITH EXCESSIVE HIP POLY LINER WEAR, AND THE POLY LINER WAS FRACTURED. THE FEMORAL HEAD WAS CONTACTING THE METAL CUP AND CREATED METALLOSIS WITHIN THE HIP JOINT CAPSULE. THERE WAS OSTEOLYSIS BEHIND THE ACETABULAR CUP AND THE IMPLANTED PRESENTED TO BE LOOSE. THE ACETABULAR CUP WAS REMOVED, THE HIP JOINT WAS DEBRIDED FROM METALLOSIS TISSUE AND BONE, AND THE PATIENT REQUIRED AN ALLOGRAFT FEMORAL HEAD BONE GRAFTING SUBSTITUTE WITHIN THE ACETABULUM. A NEW COMPETITOR G7 MULTI-HOLE CUP WAS IMPLANTED WITH SCREWS AND A LATERALIZED HIP LINER. A 36MM +10 MM HEAD WAS IMPLANTED TO MATCH THE COMPETITOR COMPONENTS. THE SURGEON HAD TO MAKE UP LEG LENGTH WITH +

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Pain

  MAUDE report 19997011 ↗
• InjuryDec 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, THIS PATIENT WAS REVISED BY SURGEON DUE TO THE CUP AND PELVIC PLATES FAILED. THE CUP SHIFTED POSITION AS IT LOST FIXATION AND THE PELVIC PLATE SCREWS BACKED OUT. PATIENT WAS REVISED TO COMPETITOR'S DEVICES. A NEW EXACTECH FEMORAL HEAD WAS USED. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18395009 ↗
• InjuryJul 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2013. THE PATIENT WAS REVISED ON (B)(6) 2023. ACETABULAR COMPONENTS WERE LOOSE. ALL COMPONENTS WERE REMOVED AND COMPETITOR ACETABULAR COMPONENTS WERE IMPLANTED. REPLACED ORIGINAL EXACTECH HIP HEAD WITH REVISION SLEEVE AND HEAD. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE CASE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 17322369 ↗
• InjuryJul 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  AS REPORTED, THIS FEMALE PATIENT HAD A LEFT SIDE REVISION OF THE CUP AND LINER DUE TO PAIN AND LOOSENING. X-RAYS SHOW A LARGE BONEY DEFECT AROUND THE CUP. A NEW EXACTECH HEAD WAS IMPLANTED. THE DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Aseptic loosening; Failure of Implant; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15128265 ↗
• InjuryMay 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10.5 YEARS POST INITIAL RIGHT THA, THE (B)(6) YEAR OLD MALE PATIENT WAS BROUGHT BACK FOR OSTEOLYSIS OF THE RIGHT HIP. THE HIP WAS DISLOCATED, FEMORAL HEAD REMOVED, STEM FOUND TO BE WELL FIXED. ATTENTION TURNED TO CUP. THE LINER WAS REMOVED WITH THE USE OF A CHISEL, THE BONE SCREW WAS REMOVED. THE CUP FOUND TO BE LOOSE AND WAS REMOVED. THE PATIENT RECEIVED 40CC OF OPTECURE MIXED WITH A CRUSHED FEMORAL HEAD ALLOGRAFT. A BIOMET G7 MULTIHOLE CUP WITH DUAL MOBILITY WAS IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICES WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14526872 ↗
• InjuryMar 23, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) Y/O FEMALE¿S PRESENT WITH RIGHT HIP PAIN AND WAS SCHEDULED FOR A REVISION DUE TO OSTEOLYSIS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE NOT RETURNED DUE TO HOSPITAL POLICY. THIS PATIENT IS KNOWN TO HAVE ARTHRITIS.

  Patient problems: Osteolysis

  MAUDE report 9866320 ↗

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, NEUT
• 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-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-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-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-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-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-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-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-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-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-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-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-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-0787-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replaceme

…and 1 more.