Novation 180-01-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862037008), received between Oct 1, 2019 and Apr 29, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. IT WAS NOTED THE SURGEON OBSERVED SCAR TISSUE AROUND THE ACETABULAR MARGIN. THE POLYETHYLENE WAS WORN SUPERIORLY. OSTEOLYTIC AREAS SUPERIORLY WERE DEBRIDED. THE PATIENT WAS AWAKENED AND RETURNED TO RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Scar Tissue

  MAUDE report 21930008 ↗
• InjuryJan 27, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METAL RELATED PATHOLOGY, DISCOMFORT, SYNOVITIS, AND PAIN. INITIAL SURGERY AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Metal Related Pathology; Pain; Synovitis

  MAUDE report 21243431 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A BFARM REPORT (B)(4) AND THROUGH LEGAL NOTIFICATIONS THAT AN 86 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED IN (B)(6) 2020, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2023, APPROXIMATELY 3 YEARS POST THE INITIAL PROCEDURE. INITIALLY, THE CLIENT WAS FREE OF SYMPTOMS POSTOP. SINCE THE END OF 2022, THE CLIENT HAD BEEN SUFFERING PAIN IN HER RIGHT GROIN AND RIGHT THIGH. DURING SUBSEQUENT CHECK-UP, THE CLIENT WAS DIAGNOSED WITH PREMATURE WEAR OF THE IMPLANT COMPONENT, RESULTING IN LOOSENING OF THE SOCKET WITH CYST FORMATION AND A FRACTURE. PRIOR TO THE OPERATION, THE PATIENT SUDDENLY FELT CONSIDERABLE PAIN AFTER TAKING ONE STEP. X-RAY AND CT DIAGNOSTICS REVEALED A RUPTURED CYST IN THE AREA. THE X-RAY CONTROL SHOWED DECENTRATION OF THE PROSTHESIS HEAD AND THE CT THEN SHOWED UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED DURING THE PROSTHESIS REVISION IN (B)(6) 2023. DUE TO THE SIZE OF THE OSTEOLYSIS AND THE RESULTING LACK OF CUP ANCHORING, THE CUP WAS CHANGED TO A COMPETITOR¿S REVISION HIP CUP WITH A TAB AND ILIAC PEG ((B)(4), MRS TITAN MAXIMUM, REF 54652-02). FURTHERMORE, THE CYSTS IN THE SOCKET WERE CURETTED AND SEALED USING

  Patient problems: Cyst(s); Fibrosis; Hip Fracture; Osteolysis; Pain

  MAUDE report 20552914 ↗
• InjurySep 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 135 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE PAIN; SEVERE OSTEOLYSIS, EXCESSIVE SOFT TISSUE DEBRIS CONSISTENT WITH SYNOVITIS, GROSSLY LOOSE FEMORAL STEM, LOOSE CUP, EXCESSIVE POLYETHYLENE WEAR ON LINER WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION . 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: Osteolysis; Pain; Synovitis

  MAUDE report 20170581 ↗
• InjuryJul 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE LEGAL BRIEF THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Synovitis

  MAUDE report 19656955 ↗
• InjuryMay 29, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, AND ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 19418166 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 12 YEARS POST INITIAL LEFT THA, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCED AN ACETABULAR FRACTURE THAT CAUSED CUP TO COME LOOSE. PATIENT HAD EXACTECH FEMORAL HEAD SWAPPED OUT TO A 32MM +10 OFFSET 12/14 BUT THE EXACTECH ACETABULAR IMPLANTS WERE REMOVED AND REPLACED WITH OTHER DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 19010609 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH HIP REPLACEMENT STUDY, APPROXIMATELY THIRTEEN DAYS POST THA, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCED PERIPROSTHETIC FEMORAL FRACTURE. A REVISION OF THE FEMORAL HEAD AND STEM WAS PERFORMED NINE DAYS LATER. THE EVENT IS UNLIKELY RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. THE EVENT IS NOTED AS ¿RESOLVED¿ ON (B)(6) 2021 AND THE PATIENT WAS DISCHARGED TO HOME CARE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12149127 ↗
• InjuryOct 1, 2019Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ORIGINAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON THIS FEMALE PATIENT ON (B)(6) 2009. THE SURGEON BROUGHT THE PATIENT IN BECAUSE THEIR ACETABULAR CUP AND LINER WERE SPUN OUT AND LOOSE WHEN HE LOOKED AT THEIR X-RAY. THE SURGEON OPENED THE JOINT IN STANDARD FASHION. THE SURGEON DECIDED TO PULL EVERYTHING OUT AND IMPLANT STRYKER FEMORAL COMPONENTS AND ACETABULAR COMPONENTS. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION AND IS EXPECTED TO HAVE A GOOD OUTCOME. THERE WAS NO DELAY TO THE SURGERY. THE REP WAS PRESENT AT THE TIME OF THE SURGERY. THE HOSPITAL DID NOT RELEASE IMPLANTS TO BE RETURNED TO EXACTECH.

  Patient problems: Failure of Implant

  MAUDE report 9139393 ↗

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