PINNACLE 1219-36-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295014485), received between Jan 4, 2018 and Nov 6, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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.

• InjuryNov 6, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED: WHEN BENDING DOWN, A PAIN IN THE LEFT GROIN IS FELT. SINCE THEN, NOISE IN THE LEFT HIP. PRESENTATION IN THE EMERGENCY ROOM ON (B)(6) 2023. IN IMAGING DIAGNOSTICS (X-RAY AND COMPUTED TOMOGRAPHY), A LUXATED INLAY WAS FOUND. THIS RESULTED IN AN OPERATION ON (B)(6)2023 WITH CHANGE OF HEAD AND INLAY. THE PATIENT FELT A PAINFUL SENSATION IN THE GROIN. FROM THEN ON, HE COULD NO LONGER ADEQUATELY LOAD THE LEFT LEG AND FELT A MECHANICAL BLOCKAGE OF THE HIP JOINT. IN ADDITION, THE PATIENT HEARD A RUBBING SOUND.

  Patient problems: Pain

  MAUDE report 18073004 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LINER DISASSOCIATION. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16878714 ↗
• InjuryDec 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATED CAUSING PAIN. NO PRIOR REVISION. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Joint Dislocation; Pain

  MAUDE report 13098625 ↗
• InjuryMar 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO DISLOCATION. NEW HEAD AND LINER IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2021; (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 11399431 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8108003 ↗
• InjuryNov 26, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION.

  Patient problems: Joint Dislocation

  MAUDE report 8102032 ↗
• InjuryNov 19, 2018Material Disintegration; Fracture; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Material Disintegration; Fracture; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED DUE TO LINER DISASSOCIATED FROM THE CUP.

  Patient problems: No Code Available

  MAUDE report 8086083 ↗
• InjuryApr 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7428318 ↗
• InjuryJan 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES INFECTION, DISLOCATION, MUSCLE DAMAGE AND ANEMIA. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY,PATIENT WAS REVISED TO ADDRESS DISLOCATION,STATUS POST COMPLEX RIGHT REVISION. REVISION NOTES REPORTED OF ANTERIOR DISLOCATION. CLINICAL NOTES REPORTED OF STAPH INFECTION AND PURULENT DRAINAGE. IT WAS ALSO REPORTED THAT THE PATIENT HAS A RIGHT FEMORAL FRACTURE DUE TO AN ACCIDENT BUT THIS WILL NOT BE CODED SINCE IT WAS NOT DUE TO DEPUY PRODUCT. . DOI: (B)(6) 2010; DOR: (B)(6) 2010; RIGHT HIP.

  Patient problems: Anemia; Joint Dislocation; Tissue Damage; Unspecified Infection

  MAUDE report 7163980 ↗