PINNACLE 1219-22-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295012726), received between Mar 1, 2019 and Mar 20, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS HIP DISLOCATED, SO HE REVISED THE STEM AND ADDED MORE OFFSET TO INCREASE HER STABILITY. DOI: (B)(6) 2014. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9861616 ↗
• InjuryJan 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION SURGERY WHEREIN THE STEM, PROXIMAL SLEEVE AND LINER WERE REVISED. REASON FOR REVISION IS UNKNOWN. DOI: (B)(6) 2011; DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9612356 ↗
• InjuryOct 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATION POST-OP. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT WAS GIVEN THE RIGHT HIP REPLACEMENT OPERATION, 3 DAYS AFTER OPERATION, THE PATIENT FELT PAINFUL ON THE RIGHT HIP, CHECKED THE RIGHT HIP, NOTED DISLOCATION, FAILED TO RELOCATE MANUALLY. THE PATIENT WAS GIVEN THE OPERATION OF CLOSED REDUCTION OF ARTIFICIAL JOINT OF RIGHT HIP ON (B)(6) 2018. THE PATIENT FELT PAINFUL ON (B)(6) 2019. ON (B)(6) 2019 CONSCIOUSLY INCREASED PAIN IN THE RIGHT HIP, ACCOMPANIED BY LIMITED MOBILITY, INVOLUNTARY HIP FLEXION, THE SURGEON REVIEWED THE HIP POSITIVE LATERAL X-RAY SHOWING POSTOPERATIVE DISLOCATION OF THE RIGHT HIP. THE PATIENT WAS GIVEN THE OPERATION OF ARTIFICIAL TOTAL HIP REVISION UNDER GENERAL ANESTHESIA ON (B)(6) 2019. THE PATIENT RECOVERED SMOOTHLY AFTER SURGERY.

  Patient problems: Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9152085 ↗
• MalfunctionMar 1, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  PPF AND MEDICAL RECORDS RECEIVED. THERE WERE NO ALLEGATIONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN. OPERATIVE FINDINGS REPORTED OF POLYETHYLENE LINER FRACTURED AND MANY PIECES WERE REMOVED. THE METAL HEAD OF THE FEMORAL COMPONENT WAS ARTICULATING AGAINST THE ACETABULAR SHELL AND THE FLUID ASPIRATED FROM THE HIP PRIOR TO ENTERING THE JOINT WAS BLACK AND OPAQUE CONSISTENT WITH METALLOSIS. DOI: (B)(6) 2010 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8382220 ↗