MultiPolar® 5001-50-28 (REF 00-5001-050-28)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024115453), received between Feb 10, 2021 and Sep 28, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2021Difficult to Insert; Difficult to Insert

  UPON REASSESSMENT OF THE REPORTED EVENT, THE LINER WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539615 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 12533523 ↗
• InjuryMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT PRESENTED TO THE HOSPITAL EMERGENCY DEPARTMENT DUE TO RIGHT HEMI ARTHROPLASTY DISLOCATION APPROXIMATELY 20 DAYS AFTER IMPLANTATION. DURING CLOSED REDUCTION, THE OUTER BALL AND PLASTIC DISASSOCIATED. THE PATIENT WAS ADMITTED FOR A REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 11782310 ↗
• MalfunctionFeb 10, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11306549 ↗

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-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-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-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