PROCOTYL PHA06218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684PHA062181), received between Sep 26, 2022 and Sep 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT RECEIVED A LEFT HIP PROSTHESIS ON (B)(6) 2015 AND A RIGHT HIP PROSTHESIS ON (B)(6) 2016, BOTH WERE PERFORMED AT HOSPITAL (B)(6). DURING 2017, PATIENT SUFFERED HIS FIRST HIP DISLOCATION. THEN, DURING 2018, PATIENT SUFFERED A SECOND DISLOCATION. ON THE SAME YEAR, 2018, THE PATIENT WAS DIAGNOSED WITH A PSEUDOTUMOR. PATIENT SUFFERED AN ADVERSE REACTION TO THE METAL COMING FROM THE IMPLANTED DEVICES. IT IS TO NOTE THAT PATIENT IS ALLERGIC TO COBALT AND THAT THE PROSTHESIS REMAINS IMPLANTED IN PATIENT. REPORTER STATED ON INITIAL EMAIL NOTIFICATION THAT THIS WAS A CASE IMPLANTED IN 2015 WITH CONFIRMED METALLOSIS IN POSTERIOR ANALYSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 15487218 ↗