PINNACLE 1217-12-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295009207), received between Sep 27, 2017 and Aug 28, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS PERSISTENT COMPLICATIONS FOLLOWING HIP PROSTHESIS SURGERIES. PATIENT UNDERWENT INITIAL HIP REPLACEMENT IN 2019, WHICH CONSISTENTLY CAUSED ISSUES. FROM THE MOMENT OF THE OPERATION, THE PATIENT COMPLAINED OF A MEASUREMENT ISSUE; HIS OPERATED LEG WAS 2 CM LONGER. AFTER 4 YEARS OF PAIN AND MULTIPLE VISITS TO THE SURGEON, THE PATIENT DECIDED TO CONSULT ANOTHER SURGEON. AFTER SEVERAL EXAMINATIONS, A REVISION WAS DECIDED. IN (B)(6) 2023, THE LOOSENED PROSTHESIS WAS REMOVED AND A SPACER WAS PLACED DUE TO SUSPECTED INFECTION. A NEW PROSTHESIS WAS IMPLANTED IN (B)(6) 2023, BUT PAIN AND FLUID BUILDUP PERSIST. MULTIPLE TESTS (PUNCTURES, CLEAN-UP SURGERY, ARTHROSCOPY) HAVE RETURNED NEGATIVE RESULTS. REFERRED TO THE HOSPITAL, WHERE ALLERGY IS NOW BEING CONSIDERED.

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection

  MAUDE report 22911152 ↗
• InjuryMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE LINER FROM THE CUP. DOI: (B)(6) 2017, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 8611916 ↗
• InjuryMar 19, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES METAL WEAR/METALLOSIS AND LOOSENING OF CUP. DOI: (B)(6) 2007 - DOR: (B)(6) 2011, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Osteolysis; Pain; Tissue Damage

  MAUDE report 8431885 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO CORROSION.

  Patient problems: No Code Available; Pain

  MAUDE report 8247539 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2010; DOR: (B)(6) 2010; (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8155010 ↗
• InjurySep 27, 2017Difficult to Remove; Difficult to Remove

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6897010 ↗