Novation 142-36-64Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862537652), received between Oct 18, 2022 and Oct 18, 2022 — classified as 1 injury.

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 16, 2026.

Recalls naming this device

1. Dec 31, 2024Open, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SEVEN MONTHS POST REVISION OF RIGHT SIDE THA, PATIENT PRESENTED WITH A DISLOCATION. SURGEON PERFORMED A REVISION WITH GOAL OF REMOVING THE NOVATION CUP AND CONVERTING TO A LINK DUAL MOBILITY. UNFORTUNATELY BONE WAS SEVERELY DAMAGED WITH OSTEOLYSIS AND UPON IMPACTING THE NEW CUP THE MEDIAL WALL WAS PERFORATED. AFTER ATTEMPTING MULTIPLE TIMES TO GET A STABLE CUP USING SCREWS, SURGEON CONSULTED HIS PARTNERS AND IT WAS DECIDED TO CLOSE THE PATIENT WITHOUT AN ACETABULAR COMPONENT, ORDER A CT SCAN, AND PLAN FOR A MORE INVOLVED RECONSTRUCTION WITH PLATING AND AUGMENTATION NEXT WEEK. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. 510K: K173583

  Patient problems: Bacterial Infection; Joint Dislocation; Osteolysis

  MAUDE report 15628838 ↗

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