Novation 140-36-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862537331), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 injury.

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.

• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS REQUIRED, WHICH IN ITSELF JUSTIFIES THE CLAIM FOR PAIN IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A 68 YO MALE PATIENT, WHO HAD AN INITIAL LEFT HIP IMPLANTED IN (B)(6) 2019, AND WAS REVISED IN (B)(6) 2024, FOLLOWING A BICYCLE ACCIDENT THAT RESULTED IN A PELVIC FRACTURE IN WHICH THE ATTENDING PHYSICIANS HAD STATED THE FRACTURE WOULD NOT HAVE OCCURRED IF THE IMPLANTED HIP JOINT HAD BEEN FREE OF DEFECTS, INDICATED THAT IMMEDIATELY FOLLOWING THE REHABILITATION, FLUID ACCUMULATED IN THE AFFECTED JOINT, LEADING TO SIGNIFICANT IMPAIRMENT FOR THE CLIENT. SINCE THEN, HE HAS HAD TO CONTEND WITH BOTH PAIN AND LIMITATIONS IN HIS MOBILITY AND PHYSICAL CAPACITY, REQUIRING ADDITIONAL PHYSIOTHERAPY MEASURES. THE CLIENT REGULARLY TOOK PAIN MEDICATION, BEYOND USUAL AMOUNTS, UNTIL THE END OF AUGUST 2024. ALTHOUGH THE PAIN HAS SUBSIDED TO THE POINT THAT HE STOPPED TAKING PAINKILLERS BY THE END OF AUGUST, THE LIMITATIONS HAVE NOT BEEN FULLY RESOLVED. DUE TO THE FLUID BUILDUP, WHICH IN TURN WAS CAUSED BY THE PRECEDING EVENTS, HE CONTINUES TO EXPERIENCE DISCOMFORT WITH SPECIFIC MOVEMENTS THAT WOULD OTHERWISE BE UNPROBLEMATIC. THIS FLUID RETENTION RESTRICTS HIS ABILITY TO CLIMB

  Patient problems: Ambulation or Postural Difficulties; Joint effusion; Loss of Range of Motion; Pain

  MAUDE report 20610460 ↗

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