Pivot Bipolar 133-2242Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409015115), received between May 17, 2022 and May 17, 2022 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K050966); 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEMIARTHROPLASTY WAS PERFORMED ON (B)(6) 2018. DISLOCATION ON 2-MAR-2021 CAUSED PAIN. DUE TO AGE AND BEING BEDRIDDEN, THE SURGEON PLANS TO REVISE TO RECONSTRUCT OR REMOVE THE STEM BUT WILL NOT PERFORM TOTAL HIP ARTHROPLASTY. THIS REPORT IS BEING SUBMITTED BECAUSE A PROPOSED INTERVENTION WAS MENTIONED EVEN THOUGH IT HAD NOT YET OCCURRED. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

  Patient problems: Arthralgia

  MAUDE report 14418079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050966. One submission often covers many models, so check the product and lot details in each record.

• Z-2253-2014 · Jul 11, 2014 · Terminated
  Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the n
• Z-0086-2010 · Apr 29, 2009 · Terminated
  Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.