PINNACLE 2218-82-748Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295101871), received between Oct 2, 2018 and Dec 8, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Break; Break

  BROKEN PINNACLE LINER TRIAL IDENTIFIED BY CSSD. NO SURGEON IS AFFILIATED WITH THIS INCIDENT. SURGERY WAS NOT DELAYED. THE PRODUCT IN MENTION IS PART OF A CONSIGNMENT SET. THE INSTRUMENT HAS BEEN TAGGED AND IS READY FOR COLLECTION FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941627 ↗
• MalfunctionMay 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE WHITE HANDLE IS CRACKED. THE CUP IMPACTOR IS BROKEN. THE SCREW IN THE LINER TRIAL DETACHED FROM THE LINER. THE HEAD TRIAL IS SCRATCH. THE UNIPOLAR SPACER TRIAL DOES NOT SIT ON THE STEM NECK FOR PROPER TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316085 ↗
• MalfunctionOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DAMAGED LINER TRIAL FOUND DURING ROUTINE INSTRUMENT INSPECTION IN CSSD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565192 ↗
• MalfunctionMar 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  PINNACLE AB LINER TRIAL WAS DAMAGED DURING CASE. SMALL METAL LOCKING RING BROKE AND SCREW CAME AWAY FROM PLASTIC LINER. IT APPEARS THAT ALL PIECES WERE RETRIEVED, BUT IT IS DIFFICULT TO TELL.

  Patient problems: Insufficient Information

  MAUDE report 11552568 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021276 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021227 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021208 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021199 ↗
• MalfunctionOct 2, 2018Scratched Material; Scratched Material

  ITEMS HAVE NOTICEABLE SCRATCHES, SCUFFS AND DAMAGE TO THE TRIALS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926846 ↗