PINNACLE 2999-58-770Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295163435), received between Aug 12, 2019 and Jan 19, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2024Break; Break

  IT WAS REPORTED THAT THE TIP BROKE OFF OF THE END OF THE DEVICE, RESULTING IN AN INABILITY TO SCREW THE CUP ONTO THE IMPACTOR. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548034 ↗
• MalfunctionJul 25, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT CUP HANDLE IS STRIPPED AT THE TOP. SURGEON COMPLAINED CUP TOGGLED AND REQUESTED ANOTHER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390524 ↗
• MalfunctionMar 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AFTER USING CUP IMPACTOR IT WAS NOTICED THAT THE THREADS WERE DAMAGED. THE CUP WAS ALREADY IMPLANTED WITH NO ISSUES. THE CASE WAS NOT DELAYED AND PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627494 ↗
• MalfunctionJan 10, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE MTO CUP IMPACTOR BROKE AT THE END OF THE SHAFT WHERE THE THREADS MEET THE SHOULDER OF THE SHAFT. BROKE INTO 2 PIECES. BOTH PIECES WERE RETRIEVED. NO DELAY OR COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135019 ↗
• MalfunctionMar 17, 2020Crack; Crack

  CPD EMPLOYEE NOTICED WHEN HANDLE WAS REMOVED FROM WAS IT WAS CRACKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841433 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT WHILE TRYING TO DISENGAGE THE MTO PINNACLE LONG IMPACTOR THE THREADED TIP BROKE OFF INSIDE THE CUP. THE THREADED PIECE WAS RETRIEVED. THE NUMBERS ON THE HANDLE ARE AS FOLLOWS: D2999-587-70, (B)(4), GM50513MT. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417637 ↗
• MalfunctionDec 5, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THEY ATTEMPTED TO INSERT GRIPTION SEATER 54 MM SHELL WITH MTO PINNACLE LONG IMPACTOR. AFTER IMPACTION, SURGEON WAS UNABLE TO UNSCREW IMPACTOR FROM CUP. CUP HAD TO BE REMOVED. ALTERNATIVE IMPACTOR AND IMPLANT HAD TO BE USED SINCE PARTS IN EVEN CANNOT BE SEPARATED. TEN MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9416212 ↗
• MalfunctionAug 12, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE TREADS ARE STRIPPED ON THE LONG HANDLE PINNACLE IMPACTOR AND THE RETAINING CLIP IS LOOSE ON THE 48MM +4 NEUTRAL LINER TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884791 ↗