Novation 130-40-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862207098), received between Jun 7, 2022 and Apr 20, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 other recalls cover devices cleared under the same FDA submission (K121392); 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.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1732-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2119-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24928938 ↗
• InjuryMar 24, 2026Naturally Worn

  IT WAS REPORTED A PATIENT, WHO HAD A THA, REPORTED EARLY WEAR OF PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE AND INDICATED A MAJOR DISABILITY AND NEED FOR SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24678252 ↗
• InjuryMar 16, 2026Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY, ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 24611443 ↗
• InjuryDec 22, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 56 YO MALE PATIENT, WHO HAD THAS IN BOTH HIPS, INDICATED THAT AFTER SOME TIME WITH PAIN AND LOSS OF MOBILITY IN THEIR LEFT LEG, THEY WENT TO THE TRAUMATOLOGIST'S CHECK-UP AND THEY INFORMED HIM THAT THE PROSTHESIS IS TOTALLY WORN OUT AND THAT IT MUST BE CHANGED URGENTLY BECAUSE IT HAS ALREADY BEGUN TO AFFECT THE ADJACENT BONE. HE IS WITH THE PREOPERATIVE, AND THE INTERVENTION IS SCHEDULED AT A FUTURE DATE. ADDITIONALLY, THE PATIENT REPORTED COMPLICATIONS IN THE RIGHT REQUIRING CRUTCHES FOR SUPPORT AND A 70% AND TOTAL DISABILITY. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT. (B)(4). RIGHT HIP EVENT.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 23865007 ↗
• InjuryAug 27, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING; INSTABILITY; TRUNNIONOSIS; POST-REVISION INFECTION; NERVE DAMAGE; NERVE PAIN; FOOT DROP; COMPLEX REGIONAL PAIN SYNDROME; AND PAIN MANAGEMENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20076788 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A NOVATION GXL DEVICE ON THE RIGHT HIP AND THEN APPROXIMATELY 5 YEARS, 8 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19570716 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4)). PATIENT ID: (B)(6) + RIGHT HIP. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE. NO ADDITIONAL CLAIMS DISCLOSED IN SHORT FORM.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19341946 ↗
• InjuryMay 8, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE 64 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2018. THE PATIENT UNDERWENT A REVISION ON AN UNKNOWN DATE AND THE SURGEON REMOVED THE HEAD AND THEN THE LINER, WHICH WAS IN PIECES (AS SHOWN IN PHOTOS). HE THEN IMPLANTED A NEW G3 XLE LINER AND A 40+7 BIOLOX OPTIONS HEAD. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 19274741 ↗
• InjuryAug 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2018. THEY UNDERWENT RIGHT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 4 YEARS 8 MONTHS AFTER THEIR INITIAL IMPLANTATION. THE PATIENT CLAIMS TO HAVE SUFFERED FROM EXTREME PAIN, LIMPING, INSTABILITY AND A REVISION SURGERY AS A RESULT OF THIS DEVICE. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE

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

  MAUDE report 17646145 ↗
• InjuryJul 31, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL NOTIFICATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 3 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2020. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Insufficient Information; Osteolysis; Pain

  MAUDE report 17423523 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, REASON FOR THE REVISION WAS NOT REPORTED. THE PATIENT¿S GXL LINER AND CUP WERE REVISED TO COMPETITOR¿S DEVICES WITH EXACTECH CERAMIC HEADS AND SLEEVES. THE EVENT WAS NOT RELATED TO A BREAKAGE OF A DEVICE. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IMAGES AND X-RAYS WERE PROVIDED. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE SENT TO PATHOLOGY. NO PATIENT INFORMATION, HISTORY, OR COMORBIDITIES REPORTED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16756214 ↗
• InjuryJun 7, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT THA, THE (B)(6) FEMALE PATIENT HAD A REVISION DUE G2/36MM NEUTRAL GXL LINER HAS EARLY ECCENTRIC WEAR. SURGEON SWAPPED THE WORN POLY FOR A G2/36MM NEUTRAL GXLE AND A CERAMIC 36MM HEAD WITH +3.5 SLEEVE OPTION. PATIENT'S DIAGNOSIS IS POLYETHYLENE WEAR AND OSTEOLYSIS. X-RAYS RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14625444 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121392. One submission often covers many models, so check the product and lot details in each record.

• Z-2129-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. 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-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-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,