BioBall DELTA™ Ceramic Head 36Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048266025470), received between Feb 2, 2021 and Dec 2, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 18, 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.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem

  REVISION OF BIOBALL HEAD AND NECK IMPLANTS WITH BIOBALL 7.5 LARGE SLEEVE AND 36 CERAMIC BIOBALL HEAD. PARAGON STEM REMAINS IN SITU. PATIENT IS A (B)(6) FEMALE WITH BELOW AVERAGE ACTIVITY LEVELS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12916531 ↗
• InjuryJul 5, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED FOR INFECTION ON (B)(6) 2021. THIS EVENT IS THE SECOND REVISION OF THIS PATIENT, THE FIRST REVISION (INFECTION) HAS BEEN ALSO RECORDED AND REPORTED UNDER 3002949614-2021-00001. ALL IMPLANTS WERE REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 12115479 ↗
• InjuryMar 16, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  MERETE WASL INFORMED THAT A "PATIENT WAS REVISED DUE TO DISLOCATION". THE LINER FROM ANOTHER MANUFACTURER WAS RE-PLACED FROM LIPPED TO NEUTRAL AND A BIOBALL OFFSET ADAPTER WAS USED TO ADD OFFSET FOR PATIENT. THE MERETE ARTICLES BIOBALL ADAPTER AND BIOBALL DELTA CERAMIC HEAD WERE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11492237 ↗
• InjuryFeb 2, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED FOR HIP DUE TO INFECTION ON (B)(6) 2021. THIS IS THE SECOND REVISION DUE TO INFECTION FOR THIS PATIENT. THE FIRST REVISION OCCURRED ON (B)(6) 2021. THE SURGEON PERFORMED A WASHOUT AND REVISED THE RIGHT HIP, GLOBAL LINER, MERETE FEMORAL HEAD AND MERETE FEMORAL NECK WERE EXPLANTED. THE SURGEON REMOVED THE CUP SCREWS TO SEE IF THERE WAS INFECTION BEHIND THE CUP, THEN PERFORMED A WASHOUT AND IMPLANTED NEW SCREWS.

  Patient problems: Unspecified Infection

  MAUDE report 11264608 ↗