Pivot Bipolar 133-2251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822409015207), received between Dec 12, 2022 and Jun 11, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT RECEIVED A BIPOLAR ACETABULAR CUP DURING TOTAL HIP ARTHROPLASTY. ON (B)(6) 2025, A DISLOCATION OF THE BIPOLAR HEAD WAS OBSERVED. A CLOSED REDUCTION WAS ATTEMPTED WHICH RESULTED IN THE DISASSOCIATION OF THE FEMORAL HEAD FROM THE BIPOLAR HEAD. A REVISION WAS PERFORMED TO REPLACE THE OUTER CUP AND FEMORAL HEAD WITH +3MM LONGER HEAD. A POST-OP EXAMINATION REVEALED AN INDENTATION IN THE LINER. THE SURGEON COMMENTED THAT THE DISLOCATION WAS CAUSED BY THE SHORT NECK LENGTH OF THE HEAD.

  Patient problems: Arthralgia

  MAUDE report 22190582 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED BIPOLAR HIP ARTHROPLASTY ON (B)(6) 2022. DISLOCATION OCCURRED AND CAUSED PAIN. AN X-RAY CONFIRMED THAT THE HEAD WAS DISLOCATED FROM THE CUP AND THE CUP WAS DISLOCATED FROM THE ACETABULUM. ON (B)(6) 2022, A REVISION WAS PERFORMED TO REPLACE THE COMPONENTS.

  Patient problems: Arthralgia

  MAUDE report 15960774 ↗

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.