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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024115323), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.

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

• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A HIP HEMIARTHROPLASTY (SURGERY DUE TO A TRAUMA RELATED SUBCAPITAL HIP FRACTURE) IN AN ELDERLY FEMALE, THE PATIENT SUFFERED A PULMONARY EMBOLISM AND DIED INTRAOPERATIVELY. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. IF A DVT/ BLOOD CLOT OR FAT EMBOLISM BREAKS FREE, IT MAY TRAVEL THROUGH THE BLOODSTREAM AND BLOCK BLOOD FLOW TO THE LUNGS. THIS COMPLICATION IS CALLED A PULMONARY EMBOLISM WHICH CAN QUICKLY TURN FATAL. AS THIS IS A PROCEDURE-RELATED AND PATIENT CONDITION RELATED EVENT, THE DEVICE CAN BE RULED OUT AS CAUSING OR CONTRIBUTING TO THE EVENT. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 11386101 ↗

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