PINNACLE 2217-50-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 10603295098928), received between Jun 23, 2017 and Aug 27, 2026 — classified as 243 malfunctions.

The most frequently reported specific device problem is “Break” (154 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 25 most recent of 243 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Device-Device Incompatibility

  It was reported that the pinnacle polyethylene liner extractor no longer engages the liner securely due to wear and tear over time. The device was discarded. There were no reports patient or user harm. There was no significant delay. No further information was available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50477331 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141112 ↗
• MalfunctionJul 10, 2026Break

  IT WAS REPORTED THAT THE TIP OF INSTRUMENT BROKE OFF DURING SURGERY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25778979 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP, IT WAS OBSERVED THAT THE DEVICE HAD A BROKEN "TOOTH" TO GRAB THE PLASTIC AND REMOVE IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999695 ↗
• MalfunctionApr 7, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE EXTENDABLE PIN FROM THE PINN POLY EXTRACTOR WAS BENT. A REPLACED WITH A SAME-LIKE PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802610 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  THE DEVICES WERE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619322 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618971 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618446 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617775 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617687 ↗
• MalfunctionMar 5, 2026Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NOT ANY PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524239 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THE TOOTH OF LINER EXTRACTION TOOL IS BROKEN; CANNOT PROPERLY GRIP AND EXTRACT ACETABULAR LINER. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500521 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT THE METAL PINS SNAPPED OFF FROM TWO POLY EXTRACTORS. NO PATIENT EFFECTS OR PROCEDURAL DELAYS WERE REPORTED. THE KIT WAS INSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317529 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT THE METAL PINS SNAPPED OFF FROM TWO POLY EXTRACTORS. NO PATIENT EFFECTS OR PROCEDURAL DELAYS WERE REPORTED. THE KIT WAS INSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317524 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT POST TOTAL HIP REPLACEMENT PROCEDURE, AND UPON INSPECTING THE INSTRUMENTS AFTER THE PROCEDURE, IT WAS OBSERVED THAT THE TIP TO THE PINNACLE LINER EXTRACTOR WAS BROKEN OFF. IT WAS REPORTED THAT THE PIECE WAS RECOVERED INSIDE THE INSTRUMENTS AFTER TRAY. NO ADVERSE EVENT TO REPORT, NO ADVERSE EVENT WITH PATIENT AS THE RESULT OF THE BROKEN INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299008 ↗
• MalfunctionFeb 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE PINN POLY EXTRACTOR EXPERIENCED AN ISSUE WHERE THE EXTRACTOR THREAD NO LONGER ENGAGED THE TEETH DURING INSPECTION, RENDERING THE INSTRUMENT UNUSABLE. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277145 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE POLY EXTRACTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926636 ↗
• MalfunctionDec 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT WAS WORN, SO IT COULD NOT REMOVE THE LINER FROM THE ACETABULUM CUP ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688989 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT TOOTH ON THE PINNACLE LINER REMOVER BROKE OFF WHILE TRYING TO USE IT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657649 ↗
• MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A REVISION ON (B)(6) 2025 THE POLY EXTRACTOR DID NOT FUNCTION APPROPRIATELY. THE INSTRUMENT DID NOT HOOK ON THE POLY AND PULL IT AWAY FROM THE SHELL. THE REVISION IS CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621396 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT TOOTH ON THE JAW BROKE OFF. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513233 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THIS PC IS RELATED TO (B)(4) WHICH REPORTS REVISION SURGERY. THIS PC REPORTS THE EVENT OCCURRED DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A THA SURGERY FOR OA ON THE RIGHT HIP JOINT. AFTER THE SURGERY ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED DUE TO AN UNKNOWN CAUSE WITH THE PRODUCT IN QUESTION. DURING THE SURGERY, THE PRODUCT BROKE AND NO METAL FRAGMENTS FROM THE BROKEN AREA COULD BE FOUND. THERE IS A POSSIBILITY THAT THEY MAY STILL REMAIN IN THE PATIENT'S BODY, BUT NO METAL FRAGMENTS WERE VISIBLE IN THE POST-OPERATIVE X-RAY IMAGES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408368 ↗
• MalfunctionOct 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LINER EXTRACTOR HAS A BENT TIP AND IT CANNOT BE USED IN THE PROCEDURE. SPECIALIST EXPRESSED DISSATISFACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377621 ↗
• MalfunctionOct 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LINER EXTRACTOR HAS A BENT TIP AND IT CANNOT BE USED IN THE PROCEDURE. SPECIALIST EXPRESSED DISSATISFACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377591 ↗
• MalfunctionSep 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE DOES NOT WORK AS INTENDED. THE ISSUE WAS IDENTIFIED POST-OR. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976312 ↗