Novation 180-01-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862036971), received between Mar 7, 2025 and Jun 2, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K100269); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST THE INITIAL LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT COMPLAINED OF HIP PAIN. THE SURGEON DIAGNOSED WEAR OR DAMAGE OF THE LINER AND REVISION SURGERY TO REPLACE THE LINER AND FEMORAL HEAD WAS PERFORMED. BREAKAGE ON THE RIM OF THE LINER WAS OBSERVED. THE SURGEON DECIDED THERE WAS NO LOOSENING OF THE ACETABULAR CUP AND FEMORAL STEM TO BONE. THE LINER AND FEMORAL HEAD WERE REPLACED TO AN XLE LINER AND DELTA HEAD WITH ADAPTOR. THE POLYETHYLENE PARTICLES ON THE SURGICAL FIELD WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22122140 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 122 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, CATASTROPHIC POLY WEAR, THE POLY HAD BEEN WORN ALL THE WAY THROUGH AND CERAMIC/TITANIUM INTERFACE WAS MAKING AUDIBLE NOISE IN ADDITION TO 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; Metal Related Pathology; Osteolysis; Pain; Scar Tissue

  MAUDE report 21552365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100269. One submission often covers many models, so check the product and lot details in each record.

• Z-1731-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. N
• 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-2130-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant com
• Z-2125-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip
• 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-2115-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant co
• 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;