Acetabular Insert 2099-2858Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327031584), received between Aug 16, 2018 and Jan 15, 2021 — classified as 1 injury, 1 malfunction.

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 16, 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.

• InjuryJan 15, 2021Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. COMPARING THE CURRENT AND PREVIOUS REVISION USAGE SHEETS, A CONSTRAINED LINER, FEMORAL HEAD, AND RESTORATION MODULAR PROXIMAL BODY WERE REVISED TO A RESTORATION MODULAR PROXIMAL BODY, CERAMIC V40 HEAD, AND CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 11178324 ↗
• MalfunctionAug 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  REP PROVIDED A USAGE SHEET WHICH SHOWED A SERIES II LINER AS WASTED. REP REPORTED THAT THE SURGEON HAD TRIED THAT LINER FIRST, BUT IT WASN'T STABLE. SURGEON THEN TRIED THE SECOND LINER ORIGINALLY REPORTED. A SCREW, ALSO WASTED, WAS ONLY USED TO REMOVE THE 2 REPORTED LINERS. UPDATE 26-JUL-2018: REP ADDRESSED THE REPORT OF THE SERIES II LINER BEING UNSTABLE: "THE INSTABILITY WAS RELATED TO THE ROM AND LIKELY ASSOCIATED TO THE PATIENTS SOFT TISSUE ANATOMY FROM REVISION SURGERY. IT WAS NOT RELATED TO THE IMPLANT". THE SERIES II IMPLANT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788317 ↗