MultiPolar® 5001-44-28 (REF 00-5001-044-28)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024633254), received between Jan 9, 2024 and Oct 7, 2024 — classified as 2 injuries.

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

6 other recalls cover devices cleared under the same FDA submission (K833991); 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.

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.

• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20388177 ↗
• InjuryJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: Joint Dislocation

  MAUDE report 18477569 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K833991. One submission often covers many models, so check the product and lot details in each record.

• Z-1014-2018 · Nov 29, 2017 · Terminated
  BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
• Z-0845-2016 · Jan 11, 2016 · Terminated
  Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fractu
• Z-1114-2016 · Jan 11, 2016 · Terminated
  Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER
• Z-1019-2014 · Oct 11, 2013 · Terminated
  Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several
• Z-0068-2014 · Aug 30, 2013 · Terminated
  Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
• Z-0410-2013 · Aug 31, 2012 · Terminated
  Multipolar Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar Bipolar Cup and serves as the articulation surface for the femoral