PINNACLE 2217-01-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295097594), received between Aug 15, 2017 and May 6, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE, THE IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094393 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE, THE IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094392 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE, THE IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094390 ↗
• MalfunctionMay 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. THE IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY, AND THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT DELAY, AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085081 ↗
• MalfunctionJan 17, 2025Material Discolored; Material Deformation; Illegible Information; Material Discolored; Material Deformation; Illegible Information

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE SIZE INDICATION LASER ETCHING ON THE APEX SOME ITEMS HAD BECOME EXTREMELY WORN AND FADED; IT WAS INCREDIBLY DIFFICULT TO READ CLEARLY. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181534 ↗
• MalfunctionJun 21, 2024Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENTS WERE NOT IN CONDITIONS FOR SURGERY DUE TO WEAR, SCRATCHES AND CRACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588774 ↗
• MalfunctionJul 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE THREADED TIP OF THE IMPACTOR BECAME COLD WELDED INSIDE THE CUP TRIAL. IT WOULD NOT COME FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424140 ↗
• MalfunctionJun 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 48MM CUP TRIAL AND THE TIP OF THE OFFSET CUP IMPACTOR BECAME COLD WELDED TOGETHER AND WOULD NOT DISASSOCIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079976 ↗
• MalfunctionAug 4, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE THREADS ARE EITHER STRIPPED OR BENT. THE DEVICE WILL NOT THREAD IN ANYMORE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361326 ↗
• MalfunctionNov 26, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THERE ARE TWO 48 TRIAL ACETABULAR SHELLS ARE STRIPPED AND WILL NOT CONNECT PROPERLY TO THE PINNACLE HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378936 ↗
• MalfunctionNov 26, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THERE ARE TWO 48 TRIAL ACETABULAR SHELLS ARE STRIPPED AND WILL NOT CONNECT PROPERLY TO THE PINNACLE HANDLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378905 ↗
• MalfunctionAug 5, 2019Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material

  AFTER SURGERY WITHIN MULTIPLE HOSPITAL, IN 4 ORTHOKITS WE HAVE FOUND OUT THAT THE XXX ARE HAVE OXIDATED AROUND THE INCAVED LETTERS AND NUMBERS. WHEN DID THE DEVICE PROBLEM OCCUR? AFTER USING THE ORTHOKITS FOR SURGERY. SOME HAS RUST, SOME HAS NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860879 ↗
• MalfunctionJul 31, 2019Corroded; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Corroded; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  AFTER SURGERY WITHIN MULTIPLE HOSPITAL, IN 4 ORTHOKITS WE HAVE FOUND OUT THAT THE XXX ARE HAVE OXIDATED AROUND THE INCAVED LETTERS AND NUMBERS WHEN DID THE DEVICE PROBLEM OCCUR? AFTER USING THE ORTHOKITS FOR SURGERY. SOME HAS RUST, SOME HAS NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848270 ↗
• MalfunctionSep 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CUP TRIAL IS CROSS THREADED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917207 ↗
• MalfunctionSep 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CUP TRIAL IS CROSS THREADED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917202 ↗
• MalfunctionAug 15, 2017Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PINNACLE HANDLE WILL NOT THREAD INTO THE 48 PINNACLE CUP TRIAL. THE CUP TRIAL HAS SOME BURRS THAT PREVENT THE HANDLE FROM FULLY THREADY. THE DER STATES "THE CUP TRIAL HAS SOME BURRS THAT PREVENT THE HANDLE FROM FULLY THREADING."

  Patient problems: No Information

  MAUDE report 6794069 ↗