PINNACLE 1218-28-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295011101), received between Jul 17, 2020 and Feb 24, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THA WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, OSTEOLYSIS IS OBSERVED DUE TO LINER WEAR. ON (B)(6) 2026, THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE CUP AND SLEEVE ARE RETAINED, AND THE LINER, HEAD, AND STEM WERE REPLACED.

  Patient problems: Osteolysis

  MAUDE report 24430425 ↗
• InjurySep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MARATHON LINER BECAME DISLODGED AND WAS NO LONGER IMPACTED INTO THE CUP. IT WAS LOOSELY SPINNING INSIDE OF THE ACETABULAR CUP. THERE WAS A LOOSENING OF THE LINER AT UNKNOWN INTERFACE WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23031011 ↗
• InjuryJul 17, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE PATIENT HAD UNCOMFORTABLE FEELING AT HER RIGHT HIP JOINT, AND THE SURGEON SUSPECTED THE DISLOCATION OF THE LINER (P/N: 121828048) BY X-RAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE LINER, THE STEM (P/N: 900535210), THE HEAD (P/N: 152190057). DURING THE SURGERY, THE SURGEON FOUND THAT THE METALLOSIS OCCURRED DUE TO THE LINER¿S WEAR AND THE DISLOCATION, AND THERE WAS TISSUE LIKE PSEUDOTUMOR. THE REVISION SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. THE PATIENT IS UNDER OBSERVATION. THE SURGEON COMMENTED THAT THE BACKGROUND OF THE LINER¿S DISLOCATION WAS UNCLEAR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; No Code Available

  MAUDE report 10291006 ↗