Novation 180-01-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862037022), received between Oct 25, 2019 and Aug 25, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A FAILED CUP AND LINER. AN IMAGE AND X-RAY WERE PROVIDED. PATIENT WAS REVISED TO EXACTECH DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22889331 ↗
• InjuryMay 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT'S COMPLAINTS OF THEIR LEFT HIP INITIALLY BEGAN DURING WALKING AND PROGRESSIVELY WORSENED. THE PAIN SITUATION ESCALATED AND THE CLIENT REQUIRED INPATIENT CARE. THE CLIENT WAS DISCHARGED WITH ONGOING PAIN AND LATER WAS REVISED. X-RAY'S SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND A VERY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THE RADIOLOGICAL FINDINGS WERE CONFIRMED DURING REVISION SURGERY. BECAUSE THE SOCKET WAS LOOSE AND OSTEOLYSIS OCCURRED DUE TO THE SIZE, THEN THE COMPLETE SOCKET WAS CHANGED TO A REVISION HIP CUP WITH TAB AND ILIAC PIN. THE PATIENT HAD TO STAY IN THE HOSPITAL TWO DAYS LONGER BECAUSE OF THEIR WEAKENED STATE. THE FOLLOWING REHABILITATION WAS CHALLENGING FOR THE PATIENT. AFTER REHABILITATION THE PATIENT'S SYMPTOMS HAVE NEARLY ENTIRELY SUBSIDED, WITH ONLY RESIDUAL DISCOMFORT AFTER PROLONGED WALKING. FURTHERMORE, A MISALIGNMENT HAS DEVELOPED, LEADING TO PROBLEMS IN THE RIGHT HIP AS WELL.

  Patient problems: Implant Pain; Myalgia; Osteolysis

  MAUDE report 22034780 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LOOSE CUP AND EXTENSIVE LYTIC MEMBRANE BEHIND CUP AND THICKENED, INFLAMED-APPEARING PERIARTICULAR TISSUE, THICK YELLOWISH TAN TISSUE FILLING THE JOINT SPACE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Emotional Changes; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20048946 ↗
• InjuryJul 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YRS POSTOP THE INITIAL LTHA, THE (B)(6) MALE PATIENT WAS COMPLAINING OF DISCOMFORT AND CUP LOOSENING WAS NOTED ON X-RAY. ALL ACETABULAR COMPONENTS WERE EXPLANTED AND REPLACED WITH A COMPETITOR. FEMORAL STEM REMAINED INTACT AND FEMORAL HEAD WAS REPLACED WITH A FEMORAL HEAD 28MM OD AND ADAPTER +3.5MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12128424 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HIP REPLACEMENT STUDY, APPROXIMATELY 5 YEARS POST-OP THA, THE 57 Y/O MALE PATIENT PRESENTED WITH LEFT GROIN PAIN AND FIXED COMPONENT. A FOLLOW UP X-RAYS NOTED OSTEOLYSIS WITH PERI-ACETABULAR IMPLANT ASSOCIATED. A REVISION OF THE LEFT HIP WAS COMPLETED AND FOUND LOOSENING. DEVICES WILL NOT BE RETURNED. THIS PATIENT¿S HISTORICAL INFORMATION INDICATES THERE WERE NO COMORBIDITIES. PATIENT WAS DISCHARGED AFTER 2 DAYS TO AT HOME CASE WITH A WALKER.

  Patient problems: Osteolysis

  MAUDE report 9520730 ↗
• InjuryNov 25, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION OF THE LEFT THA BECAUSE THE STEM WAS LOOSE. THE CUP WAS WELL FIXED BUT HE WANTED TO ADJUST THE VERSION A BIT, SO HE PULLED THE SHELL AS WELL. THE INDEX SURGERY DATE WAS (B)(6) OF 2018, HOWEVER I DID NOT HAVE A DATE.

  Patient problems: Failure of Implant

  MAUDE report 9369155 ↗
• InjuryOct 25, 2019Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ORIGINAL TOTAL HIP ARTHROPLASTY WAS PERFORMED ON THIS FEMALE PATIENT¿S LEFT SIDE. THE SURGEON DECIDED TO REVISE THIS PATIENT¿S HIP BECAUSE THE ACETABULAR CUP WAS LOOSE. THE SURGEON MADE HIS INCISION IN STANDARD FASHION. THE SURGEON THEN KNOCKED OFF THE FEMORAL HEAD WITH A BONE TAMP. THE SURGEON THEN REMOVED THE CUP, LINER AND SCREW TOGETHER BECAUSE IT WAS SPUN OUT AND LOOSE. THE SURGEON THEN REAMED THE ACETABULUM TO A SIZE THAT THE SURGEON WAS HAPPY WITH, THEN IMPLANTED A STRYKER CUP AND A 12/14 EXACTECH FEMORAL HEAD WHICH ACHIEVED GREAT STABILITY. THE SURGEON THEN CLOSED HIS INCISION IN STANDARD FASHION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION AND IS EXPECTED TO HAVE A GOOD OUTCOME. HOSPITAL DID NOT RELEASE IMPLANTS TO BE SENT TO EXACTECH.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9240040 ↗

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-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-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-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-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-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-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-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-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-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-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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