PINNACLE 2217-50-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295099093), received between Jul 24, 2023 and May 14, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, UPON EXAMINATION IN RESETTING THE INSTRUMENTS, THE 40MM PINNACLE IMPACTOR TIP WAS SEPARATING AT THE CONNECTION OF METAL AND PINK POLY. THE INSTRUMENT WAS REMOVED FROM THE SET AND DISPOSED. THE TOTAL HIP REPLACEMENT WENT AS EXPECTED WITH NO DELAYS OR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176774 ↗
• 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 25094309 ↗
• 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 25094302 ↗
• 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 25094301 ↗
• 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 25094299 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093512 ↗
• 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 25085056 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097096 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077582 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077482 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077425 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077414 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077406 ↗
• MalfunctionAug 15, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE REAMER HANDLE END BROKE AND THE PINK IMPACTOR TIP COLLAR WAS LOOSE. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992842 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT THE IMPACTOR TIP IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19804307 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT THE KINCISE WONT FIRE PROPERLY AFTER LIMITED USE.PLASTIC TRAYS BROKEN IN TRIALS, NOT COMPLAINT.(DEPUY HIP CORE CASE 2+ 4 MIDDLE TRAY, DEPUY HIP TRAY 1 +4 MIS, SUMMIT TRAPPED HIP)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516912 ↗
• MalfunctionJul 24, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED. A. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY, THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? YES. THE METAL PART THAT THREADS ON TO AN IMPACTOR WAS NOT ATTACHED TO THE PLASTIC TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379265 ↗