PINNACLE 1217-60-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295010432), received between Nov 13, 2018 and Feb 12, 2026 — classified as 8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT. B. PLEASE CONFIRM IF THE FEMORAL HEAD AND ACETABULAR CUP FRACTURED OR IF THIS WAS AN ACETABULAR BONE FRACTURE. BONY FRACTURE, NOT IMPLANT.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Laxity

  MAUDE report 24327037 ↗
• InjuryJan 21, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF CUP AT NON-CEMENTED INTERFACE. CUP WAS REMOVED AND HEAD WAS EXCHANGED. THERE WAS NO SURGICAL DELAY, NO PATIENT CONSEQUENCE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21196899 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED, SO ALL IMPLANTS WERE REMOVED. PATIENT HAD AN INFECTION PREVIOUSLY AND SURGEON DID A SINGLE STAGE REVISION ON (B)(6). DOI: (B)(6) 2021 - DOR: (B)(6) 2021 ( LEFT HIP).

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

  MAUDE report 12267978 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED SO ALL IMPLANTS WERE REMOVED. PATIENT HAD AN INFECTION PREVIOUSLY AND DR (B)(6) DID A SINGLE STAGE REVISION ON (B)(6). NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT HIP.

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

  MAUDE report 12260304 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9545401 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9545365 ↗
• InjuryMay 9, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE SHELL, LINER, AND HEAD WERE REVISED TO ADDRESS LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. DOI : (B)(6) 2019; DOR : (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8595824 ↗
• InjuryNov 13, 2018Failure to Osseointegrate; Failure to Osseointegrate

  LITIGATION ALLEGES LOOSENING OF CUP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8066496 ↗