Novation 180-01-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862036995), received between Nov 10, 2021 and Sep 2, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Loss of Osseointegration

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Pain

  MAUDE report 50572095 ↗
• InjuryAug 21, 2025Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP TOTAL ARTHROPLASTY. SUBSEQUENTLY, THIRTEEN AND HALF (13.5) YEARS LATER, THE PATIENT'S X-RAYS INDICATED A MALPOSITIONED ACETABULAR CUP AND POLYETHYLENE WEAR. THE PATIENT UNDERWENT A LEFT HIP REVISION FOUR (4) DAYS LATER. THE ACETABULAR CUP, LINER AND FEMORAL HEAD WERE REVISED. THE CUP AND LINER WERE NOTED TO BE A COMPETITOR'S IMPLANTS. INTRAOPERATIVELY, IT WAS NOTED THE PATIENT NEEDED BONE GRAFT DUE TO POLY WEAR, OSTEOLYSIS AND CUP REMOVAL. THERE WAS AN UNEXPECTED SURGICAL DELAY OF 30-45 MINUTES REPORTED DUE TO THE ACETABULAR CUP BEING LOOSE AND FALLING OUT. AS A RESULT, A FULL ACETABULAR COMPONENT REVISION WAS NEEDED INSTEAD OF THE PLANNED REVISION OF JUST THE POLYETHYLENE COMPONENTS AND THE FEMORAL HEAD EXCHANGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22859786 ↗
• InjuryFeb 26, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METAL RELATED PATHOLOGY AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO IMAGES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21471702 ↗
• InjurySep 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD HIP PROSTHESES FROM EXACTECH IMPLANTED ON THE RIGHT ON (B)(6) 2018. DURING OUTPATIENT CHECK-UPS, WITH MILD LOAD-RELATED COMPLAINTS, DECENTRATION OF THE PROSTHESIS HEAD WAS NOTICED FOR THE FIRST TIME IN (B)(6) 2021 AND AN ACETABULAR FOREIGN BODY GRANULOMA WAS SUSPECTED. DUE TO A TRAUMATIC ACETABULAR FRACTURE WITH ACETABULAR LOOSENING, A REVISION WITH ACETABULAR REPLACEMENT TO A REVISION ACETABULAR CUP WAS CARRIED OUT IN (B)(6) 2023. IN RETROSPECT, IT IS LIKELY THAT THE FRACTURE WAS AT LEAST EXACERBATED BY THE OSTEOLYSIS CAUSED BY PREMATURE PE ABRASION. RELATED TO 1038671-2021-00269 (LEFT HIP REVISION).

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 20277809 ↗
• InjuryFeb 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL BRIEF, APPROXIMATELY FIVE YEARS POST INITIAL THA, THIS FEMALE PATIENT EXPERIENCE SEVERE PAIN IN HER RIGHT HIP, AND WAS SUBSEQUENTLY DIAGNOSED WITH LOOSENING OF THE HIP SYSTEM AND POLYETHYLENE WEAR OF THE ACETABULAR COMPONENT. PATIENT HAD SUSTAINED SEVERE AND PERMANENT INJURIES; SHE WAS REQUIRED TO UNDERGO MULTIPLE PERMANENT AND PAINFUL REVISION SURGERIES, INCLUDING THE REMOVAL AND RE-IMPLANTATION OF A REPLACEMENT PROSTHETIC HIP. SHE HAS REQUIRED MANY MONTHS OF HOSPITALIZATION, PHYSICAL THERAPY, AND OTHER CARE. SHE HAS AND WILL CONTINUE TO BE BEDRIDDEN. SHE HAS AND WILL CONTINUE TO EXPERIENCE SEVER AND PERMANENT PAIN; AND SHE HAS AND WILL CONTINUE TO SUFFER SEVERE AND PERMANENT COMPLICATIONS AND OTHER INJURIES TO THE RIGHT HIP.

  Patient problems: Failure of Implant

  MAUDE report 13500418 ↗
• InjuryNov 10, 2021Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, PLAINTIFF UNDERWENT REVISION SURGERY TO REMOVE THE DEFECTIVE DEVICE, EXCISE A LARGE OSTEOLYTIC CYST, AND REBUILD BONE SUPPORT A NEW ACETABULAR CUP. THE DEVICE IMPLANTED INTO PLAINTIFF WAS DEFECTIVE AND UNREASONABLY DANGEROUS IN THAT THE ACETABULAR LINER CATASTROPHICALLY FRACTURED, WHICH ALLOWED THE FEMORAL HEAD TO ARTICULATE DIRECTLY AGAINST THE INITIAL CUP AND CAUSE SEVERE PAIN AND INJURY TO THE PLAINTIFF AND NECESSITATED A REVISION SURGERY ONLY EIGHT YEARS AFTER IMPLANT. PLAINTIFFS LEARNED FOR THE FIRST TIME THAT THE DEVICE WAS DEFECTIVE AFTER ITS REMOVAL ON OR ABOUT (B)(6) 2020. AS A DIRECT RESULT OF THE DEFECTIVE NATURE OF THE DEVICE, THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DRAINAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING, IMPINGEMENT AND/OR DETACHMENT; METALLOSIS; SOFT TISSUE DAMAGE; ADVERSE LOCAL TISSUE REACTION; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. AS A FURTHER DIRECT RESULT, THE PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT N

  Patient problems: Failure of Implant

  MAUDE report 12787773 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.