PINNACLE 1219-36-162Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295014621), received between Feb 12, 2019 and May 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2019 WHERE A CORAIL PINNACLE WAS IMPLANTED. AS PER THE NOTES, THE PATIENT DISLOCATED 2 TIMES AND WAS THEN BROUGHT BACK TO THEATRE ON (B)(6) 2019 WHERE THE PINNACLE LINER WAS EXCHANGED TO A CONSTRAINED LINER AND A LONGER FEMORAL HEAD IMPLANTED. PATIENT HAS NOW PRESENTED WITH PAIN WITH A THE X RAY SHOWING THE HIP TO BE DISLOCATED. ACCORDING TO THE PATIENT, HIS HIP HAS NEVER BEEN RIGHT AND HE HAS SUFFERED WITH PAIN SINCE THE ORIGINAL INDEX SURGERY. THE X RAY IMAGES SHOW A DISLOCATED HIP, LOCKING RING AROUND THE NECK AND THE RING THAT LOCKS THE POLY INTO THE SHELL, BROKEN AND LYING IN THE SURROUNDING SOFT TISSUE. ON OPENING THE HIP, BACKEND SOFT TISSUE WAS EVIDENT, THE POLY LOCKING RING WAS LOCATED, BENT AND BROKEN AND THE POLY LINER WAS FOUND EXERTED IN THE SOFT TISSUE AND NOT IN THE SHELL. THE BLACKENED TISSUE WAS REMOVED, THE LINER REMOVED. A NEW CONSTRAINED LINER WAS IMPLANTED AND A HEAD WITHOUT A ¿SKIRT¿ IMPLANTED (THE PREVIOUS HEAD AD A SKIRT AND WOULD HAVE RESULTED IN MORE IMPINGEMENT) ONLY THE PRODUCTS REMOVED IN THIS SURGERY HAVE BEEN LISTED. THIS COMPLAINT WAS CREATED TO CAPTURE THE PREVIOUS REVISION ON (B)(6) 2019 DUE TO DISLOCATION. T

  Patient problems: Joint Dislocation

  MAUDE report 14461229 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF HAS NO ALLEGATION, HOWEVER PPF HAS REPORTED OF REVISION. THE LINER AND HEAD WERE REPORTED TO THE IMPACTED PRODUCT. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP) FIRST REVISION. PLEASE (B)(4) FOR THE RIGHT HIP SECOND REVISION.

  Patient problems: No Code Available

  MAUDE report 9217998 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PENDING PRODUCT LIABILITY REPORTS: IT WAS ALLEGED THERE WAS DISLOCATION WITH A CLOSED REDUCTION AFTER THE FIRST REVISION. THE PATIENT WAS REVISED TO ADDRESS CHRONIC INSTABILITY OF THE LEFT HIP. THIS INCIDENT INVOLVES THE LEFT HIP. THE IMPLANT DATE WAS (B)(6) 2004. THE REVISION OCCURRED ON (B)(6) 2011.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8332137 ↗