Novation 180-01-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862037046), received between May 12, 2021 and Jul 15, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT (CONFIRMED ON X-RAY) PROCEDURE AND THEN WAS REVISED. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR. THE STEM WAS RETAINED AND A NEW HEAD IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. CONCOMITANT DEVICES: (B)(6), 136-36-53 - NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS. (B)(6), 164-02-09 - ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 9. (B)(6), 101-05-20 - 3.2MM DRILL BIT 20MM 1PK. (B)(6), 180-01-58 - NV CROWN CUP CLSTR HOLE 58MM GROUP 3. (B)(6), 180-65-20 - ALTEON 6.5MM SCREW, 20MM. (B)(6), 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM.

  Patient problems: Insufficient Information

  MAUDE report 22506716 ↗
• InjuryFeb 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METAL RELATED PATHOLOGY, OSTEOLYSIS, AND SYNOVITIS. 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: Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 21415344 ↗
• InjuryFeb 4, 2025Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT HIP ARTHROPLASTY AND THEN APPROXIMATELY 7 YEARS, 11 MONTHS LATER THE PATIENT EXPERIENCED A REVISION SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Loss of Range of Motion; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 21303906 ↗
• InjuryJul 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT RECEIVED AN INITIAL TOTAL RIGHT HIP ARTHROPLASTY AND THEN APPROXIMATELY 8 YEARS, 2 MONTHS LATER WAS REVISED ON (B)(6) 2023 FOR ¿CONSIDERABLE WEAR¿ AND THE IMPLANT HAD LOOSENED THE SOCKET WITH ADVANCED GRANULOSTEOLYSIS. THE PATIENT THEN RECEIVED SUBSEQUENT TREATMENT FROM (B)(6) 2023 FROM A REHABILITATION CLINIC. THE PATIENT HAD BEEN SCHEDULED FOR REVISION SURGERY IN 2021, BUT THIS WAS POSTPONED DUE TO COVID. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Osteolysis

  MAUDE report 19745754 ↗
• InjuryMay 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 11 YRS POSTOP THE INITIAL L THA, THIS (B)(6) Y/O MALE PATIENT WAS BROUGHT TO SURGERY FOR LEFT HIP REVISION. X RAYS SHOWED OSTEOLYSIS AROUND THE CUP WITH POSSIBLE LOOSE CUP. THE FEMUR WAS EXPOSED, THE FEMORAL HEAD WAS ELEVATED AND REMOVED FROM THE STEM. THE STEM WAS CHECKED AND FOUND TO BE WELL FIXED. THE ACETABULAR COMPONENTS WERE EXPOSED, THE POLY LINER WAS REMOVED WITH THE AID OF A LINER REMOVAL TOOL (THE DAMAGE TO THE RETUNED IMPLANT WILL SHOW THE DAMAGE FROM THE TOOL AROUND THE PERIPHERAL). THE IN LINE ACETABULAR IMPACTOR WAS SEATED INTO THE CUP, THE CUP WAS LOOSE, AND MOVEMENTS ALLOWED THE CUP TO BE REMOVED. THE ACETABULUM WAS PACKED WITH GRAFT AND REVERSE REAMED. THE PATIENT RECEIVED A NEW 58MM MULTI-HOLE ALTEON CUP, WITH SCREWS AND A 40MM EXTENDED COVERAGE LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11812861 ↗

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