Novation 148-36-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862537904), received between Jul 2, 2024 and Jan 23, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• InjuryJan 23, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, WHO HAD AN INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2015, AND WAS REVISED ON (B)(6) 2023, UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT PRESENTED TO THE SURGEON DUE TO A DISLOCATION. THEY UNDERWENT A TOTAL HIP ACETABULAR REVISION USING DJO DUAL MOBILITY. THE PATIENT FEMORAL HEAD WAS REPLACED WITH A SLEEVE AND A NEW HEAD TO MATCH THE DJO DUAL MOBILITY. THERE WERE NO DEVICE BREAKAGES REPORTED. THERE WAS A 15-TO-30-MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO DEVICE RETURNS ANTICIPATED BECAUSE THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. THIS IS 1 OF 2 REPORTS FOR THIS CASE.

  Patient problems: Joint Dislocation

  MAUDE report 24171747 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 1 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19655967 ↗

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