Novation 146-36-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862537829), received between Dec 26, 2023 and Dec 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 6 MONTHS AND 2 DAYS POST THE PATIENT'S FIRST REVISION SURGERY, WHERE THE INLAY WAS EXCHANGED, THE PATIENT PRESENTED AGAIN DUE TO SUBLUXATIONS. THE PATIENT WAS REVISED TO A SPECIALLY APPROVED INLAY. PATIENT'S FIRST REVISION REPORTED UNDER 1038671-2024-01747.

  Patient problems: Subluxation

  MAUDE report 20925646 ↗
• InjuryDec 26, 2023Device Dislodged or Dislocated; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED DUE TO REPEATED DISLOCATIONS SUBSEQUENTLY TO PREMATURE INLAY WEAR CAPTURED IN REPORT NUMBER 1038671-2023-02272.

  Patient problems: Failure of Implant; Insufficient Information; Joint Dislocation

  MAUDE report 18395302 ↗

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