Novation 140-32-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862537263), received between Jul 22, 2022 and Apr 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryApr 19, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 69 YO FEMALE PATIENT WAS EXPERIENCING DISLOCATION, (I.E. PAIN, INFECTION). THE PATIENT DISLOCATED ANTERIORLY AND PERIPROSTHETIC FRACTURE. THE PATIENT WAS REVISED ON (B)(6) 2019.

  Patient problems: Joint Dislocation; Periprosthetic fracture; Unspecified Infection

  MAUDE report 16768902 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ONE MONTH POST THA, THERE WAS A CHANGE IN TREATMENT. AFTER THE REVISION OPERATION (B)(6) 2022, PATIENT REPORTED INSTABILITY WITH TWO DISLOCATIONS, SO ON (B)(6) 2022 THE XLE INLAY WAS CHANGED TO A 20° SHOULDER INLAY.

  Patient problems: Failure of Implant

  MAUDE report 15088518 ↗

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