PINNACLE 1217-55-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295010425), received between Nov 16, 2017 and Mar 25, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687097 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO AN INFECTION. PRODUCTS WERE EXPLANTED AND A SPACER WAS PUT IN. SURGICAL DELAY IS UNKNOWN. DOI- (B)(6) 2023, DOR- (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 17584191 ↗
• MalfunctionAug 5, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGE WAS NOT SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174941 ↗
• InjuryOct 18, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS MIGRATION AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CANCER PATIENT. CONVERTED TO TRI-FLANGE. PROXIMAL FEMUR AND SEGMENT REMOVED TO RE-ESTABLISH LEG LENGTH. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12646625 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12367007 ↗
• InjuryApr 9, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2007; DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 8495129 ↗
• InjuryApr 9, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2007; DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 8495122 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 17 JUL 2018: PPF ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, IT WAS CONFIRMED THAT THE PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8439297 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE REC¿D 3/27/2014 - PFS WAS RECEIVED FROM LEGAL, PRIMARY MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. UPDATE AD 14 JAN 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS.

  Patient problems: Discomfort; Inflammation; Pain; Unspecified Infection

  MAUDE report 8284880 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGED INFECTION AFTER FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8164239 ↗
• InjuryJun 29, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DER STATES THAT THE ORIGINAL IMPLANT DATE WAS UNKNOWN. THIS PATIENT HAD HER HIP REVISED WHERE A COMPETITOR HIP REPLACEMENT STEM WAS REMOVED AND REPLACED WITH A SUMMIT STEM AND PINNACLE CUP AT (B)(6). THE PATIENT CAME INTO THE ER AT (B)(6) HOSPITAL WITH IN 2 WEEKS OF HER REVISION SURGERY COMPLAINING OF HIP PAIN. X-RAYS INDICATES THAT HER ACETABULAR CUP HAD MOST LIKELY CAME LOOSE AND PROTRUDED THROUGH THE MEDIAL ACETABULAR WALL. THE LOOSENING WAS ALLEGEDLY BONE TO CEMENT INTERFACE WITH COMPETITOR CEMENT HAVING BEEN USED. SHE WAS CONSULTED WHERE IT WAS DECIDED THAT HE WOULD EXPLANTED ALL COMPONENTS AND LET THE PELVIS TRY AND HEAL AND RECONSTITUTE BONE. ALL IMPLANTS WERE EXPLANTED. THE PATIENT HAS OBTAINED LEGAL REPRESENTATION SO INFORMATION AVAILABLE IS LIMITED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7650848 ↗
• InjuryNov 16, 2017Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  REVISION DUE TO ACETABULAR COMPONENT MIGRATING MEDIALLY, RESULTING IN PELVIC DISASSOCIATION, REQUIRING A 2 STAGE REVISION PROCEDURE CARRIED OUT IN (B)(6) 2009.

  Patient problems: No Information

  MAUDE report 7036653 ↗