Novation 132-40-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862207050), received between Apr 7, 2023 and Sep 25, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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-2123-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjurySep 25, 2026Naturally Worn

  As reported, approximately 10 years and 7 months post the initial right total hip arthroplasty, the patient was experiencing pain and stiffness and was shown to have early wear on imaging. The patient underwent a revision where the acetabular poly liner and femoral head were swapped. 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.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 50896798 ↗
• InjurySep 16, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 77 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR OSTEOLYSIS. 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; Pain

  MAUDE report 20225585 ↗
• InjuryAug 23, 2024Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 78 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 20050235 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19650260 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT HIP ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS, 9 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19260601 ↗
• InjuryMar 6, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75 YO PATIENT, INITIAL RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH A RECALLED HIP LINER AND WAS SCHEDULED FOR A REVISION OF THEIR TOTAL HIP. THEY UNDERWENT AN ACETABULAR POLY LINER SWAP AND FEMORAL HEAD SWAP AND WERE REVISED TO A BIOLOX DELTA ADAPTER 16/18-12/14; +3.5MM SN: (B)(6), A BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD SN: (B)(6), AND A NV EHXL NEUTRAL LNR G4 40MM SN: (B)(6). THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND DEVICE IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THEY ARE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Discomfort; Implant Pain; Insufficient Information; Synovitis

  MAUDE report 18852522 ↗
• InjuryNov 15, 2023Naturally Worn; Naturally Worn

  THE PATIENT HAD AN ORIGINAL EXACTECH PRIMARY TOTAL HIP REPLACEMENT ON (B)(6) 2017 BY DR. (B)(6). THE PATIENT RETURNED TO DR. WILLIAMS'S OFFICE HAVING BEEN NOTIFIED OF ORIGINALLY BEING IMPLANTED WITH A RECALLED HIP POLY LINER. THE PATIENT WAS BOOKED FOR REVISION THA POSSIBLE FEMORAL HEAD AND ACETABULAR POLY LINER SWAP ON (B)(6) 2023. THE PATIENT HAD A FEMORAL HEAD AND POLY LINER SWAP. IT WAS NOTED THAT THE REMOVED RECALLED LINER SHOWED EARLY ABNORMAL ECCENTRIC WEAR. THE PATIENT LEFT THE OR STABLE. DURING THIS CASE THE FEMORAL HEAD IMPACTOR TIP HAD A PIECE THAT BROKE OFF OF IT WHEN USING THE INSTRUMENT TO DISENGAGE THE FEMORAL HEAD FROM THE NECK TAPER. PICTURES OF THE BROKEN INSTRUMENT ARE ATTACHED. IT WILL BE RETURNED AND A NEW ONE ORDERED TO REPLACE IT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18140311 ↗
• InjurySep 20, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL THA, THE MALE PATIENT WAS REVISED DUE TO PAIN. OSTEOLYSIS WAS NOTED ON CT AND X-RAY. BONE GRAFTING AND CEMENT WAS USED IN THE BONE LOSS AREAS. COMPETITOR'S DUAL MOBILITY CUP WAS CEMENTED INSIDE THE NOVATION CUP AND NEW EXACTECH HEAD WAS USED. THERE WAS NO ISSUES WITH SURGERY. X-RAYS AND PHOTO ATTACHED. EXPLANTS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 17786300 ↗
• InjuryApr 7, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL, APPROXIMATELY 4 YEARS POST OP THE INITIAL LEFT THA, THIS 61 Y/O MALE PATIENT WAS REVISED. PATIENT HAD PAIN DUE TO HIP JOINT PROSTHESIS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Distress; Failure of Implant; Osteolysis; Pain

  MAUDE report 16700411 ↗

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-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-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-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-2119-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component