MultiPolar® 5001-47Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024115354), received between Apr 28, 2021 and May 29, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON NEARLY ONE (1) MONTH POST IMPLANTATION DUE TO WOULD LEAKING PUS. THE PATIENT HAD A FALL UNRELATED TO THE HIP ARTHROPLASTY. IT WAS NOTED THAT THE PATIENT SUFFERED FROM MENTAL HEALTH ISSUES AND WAS IN OVERALL POOR HEALTH AT THE TIME OF THE INCIDENT. THE SURGICAL TECHNIQUE OF THE PRODUCT WAS UTILIZED.

  Patient problems: Wound Dehiscence

  MAUDE report 19418462 ↗
• InjurySep 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT HAD A LEFT BIPOLAR HEMIARTHROPLASTY AFTER A MECHANICAL FALL CAUSING A DISPLACED BASICERVICAL FRACTURE OF THE FEMORAL NECK. SUBSEQUENTLY, PATIENT UNDERWENT A CONVERSION TO A TOTAL HIP ARTHROPLASTY DUE TO RECURRENT DISLOCATIONS APPROXIMATELY 1 (ONE) MONTH LATER. DURING THE REVISION A LARGE HEMATOMA WAS EVACUATED AROUND THE ANTERIOR, POSTERIOR, AND SUPERIOR HIP. DAMAGE WAS FOUND TO THE GLUTEUS MEDIUS AND ANTERIOR CAPSULE. THE STEM WAS FOUND WELL FIXED. THE CUP, LINER AND HEAD WERE REPLACED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hematoma; Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 15513529 ↗
• InjuryOct 4, 2021Adverse 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: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 12570048 ↗
• MalfunctionApr 28, 2021Difficult to Insert; Difficult to Insert

  UPON REASSESSMENT OF THE REPORTED EVENT, THE SHELL 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 11737116 ↗

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