PINNACLE 1218-32-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295011552), received between Nov 9, 2020 and Nov 9, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REPORTED TO NCA (BFARM): "HIP-TEP RIGHT SIDE 2005 IN OUR HOSPITAL. SINCE (B)(6) 2020 MS. (B)(6) WAS COMPLAINING ABOUT STRONG PAIN IN THE RIGHT HIP. THE PAIN WAS STRONG, THE ABILITY TO WALK AND STAND WAS COMPLETELY ELIMINATED. THE PATIENT ALERTED THE AMBULANCE, WHO FINALLY BROUGHT HER IN. THE PAIN WAS NOT POSSIBLE TO BE MANAGED ON AN OUTPATIENT BASIS. ON THE OTHER HAND SHE HAS BEEN VERY SATISFIED WITH THE RIGHT HIP REPLACEMENT OVER THE YEARS. TWO YEARS AGO A HIP-TEP OF LEFT HIP TOOK PLACE. THIS ONE WAS FOLLOWED BY 2 ADDITIONAL SURGICAL INTERVENTIONS DUE TO INFECTION. RADIOLOGICAL POLYERTHYLENE DISLOCATION OF RIGHT HIP-TEP. CHANGE OF POLYETHYLENE AND HIP-HEAD ON (B)(6) 2020."

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; No Code Available; Pain

  MAUDE report 10808876 ↗