Novation 136-40-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862220318), received between May 12, 2022 and Jun 16, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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-2129-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjuryJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT THA, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. POLY WEAR WAS INDICATED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO THE HOSPITAL CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 25526241 ↗
• InjuryJan 29, 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 MALE PATIENT, INITIAL LEFT HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE PATIENT HAD LYSIS AROUND THE CUP AND STEM. THE IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR¿S DEVICES. X-RAY IMAGES WERE PROVIDED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. THE DEVICES WERE SENT TO PATHOLOGY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 18602295 ↗
• InjuryJul 18, 2023Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information; Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REVISION SURGERY ON (B)(6) 2023. NO INFORMATION HAS BEEN PROVIDED REGARDING THE PRIMARY SURGERY DATE. 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: Insufficient Information; Joint Dislocation; Osteolysis; Osteopenia/ Osteoporosis; Pain

  MAUDE report 17344469 ↗
• InjuryDec 13, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A 69 YO MALE, INITIAL RIGHT HIP IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, FOR REASONS UNKNOWN. THE SURGEON REMOVED THE CUP AND LINER AND REPLACED WITH A COMPETITOR¿S DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE ARE NO DEVICES RETURNING AS THEY WERE SENT TO PATHOLOGY. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 15971647 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE RIGHT HIP PAIN. CT AND X-RAY IMAGING SHOW EVIDENCE OF SIGNIFICANT ACETABULAR AND FEMORAL OSTEOLYSIS AND ECCENTRICITY OF THE FEMORAL HEAD IN THE ACETABULAR LINER. X-RAY RECEIVED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 14372696 ↗

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-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-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
• 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,