PINNACLE 1217-12-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295009191), received between Sep 21, 2018 and Jan 16, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE FIRST DISLOCATION INVOLVED DEPUY SYNTHES PRODUCTS (CORAIL STEM, BIOLOX CERAMIC HEAD, AND PINNACLE SHELL/LINER). THERE WAS AN ADVERSE CONSEQUENCE, THE HIP WAS DISLOCATED. THERE WAS NO SURGICAL DELAY, THE DISLOCATION HAPPENED DURING POST-OP.

  Patient problems: Insufficient Information

  MAUDE report 21169025 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF MEDICAL RECORDS, IT WAS NOTED THAT THERE WAS SIGNIFICANT OSTEOLYSIS OF THE PROXIMAL FEMUR. HIP CAPSULECTOMY WAS DONE AND DURING THIS PROCESS, A LARGE SIGNIFICANT AMOUNT OF WHITE HEMATURIA WAS EXPRESSED FROM THE JOINT. THERE WAS EXTREMELY HIGH PRESSURE. SIGNIFICANT TRUNNIONOSIS OF THE FEMORAL TRUNNION WITH THE FEMORAL HEAD, SIGNIFICANT METALLOSIS WITH TRUNNIONOSIS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Hematuria; Inflammation; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16528927 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT CORAIL/PINNACLE TOTAL HIP REPLACEMENT THREE YEARS AGO. PRESENTED BACK TO GP WITH COMPLAINT OF PAIN. X-RAY TAKEN WHICH SHOWED AN AREA OF SINUS TRACKING IN THE BONE SUSPICIOUS OF INFECTION. PROCEDURE REMOVAL OF CORAIL/PINNACLE HIP REPLACEMENT, RIGHT AND INSERTION OF 'KIWI SPACER', IE LOOSELY CEMENTED C-STEM AND MARATHON CEMENTED CUP. UPON REMOVING THE CORAIL STEM THE SURGEON STATED HE COULD SEE 'AN AREA OF PUS' IN THE FEMORAL CANAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16263383 ↗
• InjuryOct 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION INDICATED THAT THE AFFECTED SIDE IS THE RIGHT.

  Patient problems: No Code Available

  MAUDE report 10619594 ↗
• InjuryNov 13, 2018Failure to Osseointegrate; Failure to Osseointegrate

  LITIGATION ALLEGES LOOSENING OF CUP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8066420 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP REVISION, (B)(6), (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2018. SEVERAL EPISODES OF DISLOCATION OF RIGHT HIP ON DISCHARGE FROM HOSPITAL. PATIENT REQUIRED CUP REVISION. SURGEON FELT INTRA-OPERATIVELY STEM NEEDED UP-SIZING. MALE, PATIENT ID: (B)(6).

  Patient problems: Not Applicable

  MAUDE report 7899221 ↗