BENCOX Hip System HA.02I.0361Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08806373879043), received between Sep 11, 2018 and Sep 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162127); 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.

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.

• MalfunctionSep 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A PORTION OF THE METAL LOCKING RING INSIDE THE TRIAL HEAD WAS PROTRUDING OUT WHICH CAUSED THE TRIAL TO BECOME STUCK ON THE STEM TRUNNION.

  Patient problems: Not Applicable

  MAUDE report 7863458 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162127. One submission often covers many models, so check the product and lot details in each record.

• Z-1454-2017 · Feb 27, 2017 · Terminated
  Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343