Novation 140-36-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862537324), received between Nov 13, 2023 and Aug 28, 2025 — classified as 4 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K173583); 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. Dec 31, 2024Class IIOpen, Classified

   Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

   Z-1166-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE (B)(6) YO MALE PATIENT SUFFERED A DISLOCATION DUE TO A FAILED LEFT TKA SECONDARY TO INSTABILITY, RESULTING IN REVISION LEFT THA OF FEMORAL HEAD BALL AND ACETABULAR LINER. THE PATIENT WAS REVISED. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22911059 ↗
• InjuryOct 10, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT UNDERWENT A REVISION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Medical device site infection

  MAUDE report 20416117 ↗
• InjuryJul 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 45 MONTHS AFTER A TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT AND DIFFICULTY WALKING. PATIENT HAS SUFFERED INJURIES DUE TO POLY WEAR AND DEVICE FAILURE. NO OPERATIVE REPORTS WERE INCLUDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE."

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Pain; Scar Tissue

  MAUDE report 19837714 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 18127855 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173583. One submission often covers many models, so check the product and lot details in each record.

• Z-1165-2025 · Dec 31, 2024 · Open, Classified
  AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-2
• Z-0577-2024 · Nov 21, 2023 · Open, Classified
  AcuMatch Hip System, Catalog Number 142-32-27