PINNACLE 1219-36-464Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295014768), received between Jan 25, 2022 and Apr 28, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED, ON (B)(6) 2017 MRI WAS NOTED TO SHOW HETEROTOPIC BONE FORMATION SUPERIOR TO THE GREATER TROCHANTER AND ALSO AN EXOSTOSIS AT THE LEVEL OF THE GRATER TROCHANTER. THE SURGEON¿S IMPRESSION IS THE PATIENT HAS A LEFT TOTAL HIP ARTHROPLASTY WITH NO EVIDENCE FOR HARDWARE FAILURE OR OF OSTEOLYSIS. THERE IS A SMALL JOINT EFFUSION AND DEHISCENCE OF THE CAPSULE WITH FLUID OVER A PORTION OF THE GREATER TROCHANTER AND SEPARATION OF CORRESPONDING PORTIONS OF THE GLUTEUS MINIMUS AND GLUTEUS MEDIUS TENDONS. THE PATIENT CONTINUED TO HAVE PAIN AND ABDUCTOR WEAKNESS. THE PATIENT RECEIVED A STEROID INJECTION. DOI: (B)(6) 2011:? DOE: (B)(6) 2017; LEFT HIP.

  Patient problems: Extraskeletal ossification; Fatigue; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 16833718 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN, SUFFERINGS AND DIFFICULTY WALKING AND ELEVATED METAL IONS. MEDICAL RECORDS REPORTED THAT THE REASON FOR THE PERSISTENT PAIN IS WEAKNESS OF HIP ABDUCTORS WHICH WAS NOTED ON PHYSICAL EXAMINATION. PATIENT ALSO HAD HARDENED APPROACH AT THE HIP REPLACEMENT WHICH HAS LED TO DETACHMENT OF THE ANTERIOR 1/3 OF THE GLUTEUS MEDIUS AND MINIMUS AS NOTED ON THE MRI SCAN THAT HE HAD. DOI: (B)(6) 2011. DOR: NONE REPORTED. LEFT HIP. LINKED TO (B)(4) WHICH CAPTURES 1ST REVISION OF LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Extraskeletal ossification; Fatigue; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13344721 ↗