PINNACLE 1219-28-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295013266), received between Mar 10, 2020 and Mar 10, 2020 — classified as 1 injury.

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

• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION; PAIN AND DISCOMFORT, DIAGNOSED AS A FEMORAL NERVE PALSY. PATIENT COMPLAINING OF PAIN AND DISCOMFORT. SYMPTOMS CONSISTENT WITH FEMORAL NERVE PALSY. INVESTIGATIONS (MRI) AND SECOND OPINION CONSULTED. RADIOLOGIST OPINION AND VARIOUS ORTHOPAEDIC OPINION SUGGEST AN ACETABULAR CANCELLOUS BONE SCREW DESPITE BEING ONLY 25MM LONG MAY HAVE PERFORATED THE BONEY PELVIC WALL AND CAUSED IRRITATION OF THE FEMORAL NERVE. THIS WAS PURELY A SUSPICION BASED ON COLLECTIVE OPINION AS A POTENTIAL POSSIBLE CAUSE. THE PATIENT IS VERY SMALL IN STATURE AND HAS DYSPLASIA OF THE HIP. (ACETABULAR COMPONENT ONLY 44MM). THE PATIENT'S HIP WHEN REDUCED RESULTED IN A LEG LENGTHENING OF OVER ONE CM TO CORRECT THE SHORTENING OF THE AFFECTED LEG ASSOCIATED WITH THE DYSPLASIA OF THE HIP. THE POLYETHYLENE LINER WAS REMOVED AND THE SCREW REMOVED WITHOUT INCIDENT. THE LINER WAS THEN REPLACED WITH AN IDENTICAL NEW 28MM NEUTRAL 44MM POLYETHYLENE PINNACLE ACETABULAR LINER. THE CERAMIC FEMORAL HEAD REMAINED INSITU ON THE CORAIL FEMORAL STEM DURING THE LINER REMOVAL, SCREW REMOVAL, AND LINER REPLACEMENT. THE HIP WAS THEN REDUCED AND CLINICAL STABILITY WAS ACHIEVED WITH A RANGE OF MOTION PRIOR TO WOUND AND

  Patient problems: Discomfort; No Code Available; Pain; Tissue Damage

  MAUDE report 9813871 ↗