PINNACLE POROCOAT 1217-20-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295009603), received between Jun 13, 2018 and Aug 29, 2025 — classified as 2 injuries, 1 malfunction.

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 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.

• InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA. AFTER THE SURGERY, THE PATIENT HAD BEEN FOLLOWED UP ANNUALLY, BUT ON (B)(6) 2025, WHILE PLAYING WITH HER GRANDCHILDREN, SHE SUFFERED A SUDDEN DROP. ON (B)(6) 2025, IT WAS CONFIRMED THAT THE HEAD CENTER HAD SHIFTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, FOR THA POLYETHYLENE LINER DAMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AS THE CUP WAS NOT LOOSE, IT WAS LEFT IN PLACE, AND ONLY THE LINER WAS CHANGED. IT WAS NOTED THAT FIVE OF THE SIX TABS HAD BEEN WORN OFF, WHICH MAY HAVE CAUSED THE PRODUCT TO ROTATE.

  Patient problems: Joint Laxity

  MAUDE report 22923097 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY VIA THA FOR OSTEOARTHRITIS OF THE HIP. THE PATIENT¿S BONES WERE FRAGILE, AND AT THE TIME OF REAMING, REAMING HAD BEEN DONE QUITE FAR INTO THE INNER PELVIS. THE SURGEON DROVE THE CUP IN ONCE AND FIXED IT WITH SCREWS BUT REMOVED THE CUP AND SCREWS BECAUSE THERE WAS A TENDENCY TO DISLOCATE DURING REPOSITIONING. THE SURGEON DROVE THE CUP IN AGAIN, BUT THE CUP PROTRUDED THE INNER PELVIS. SINCE THERE WERE NO IMPLANTS (TMARS, FIXORB MESH, ETC.) READY FOR RECOVERY, THE SURGEON FIXED THE CUP WITH INSERTING SCREWS INTO UPPER LATERAL PART OF THE CUP AND CLOSED THE WOUND. THE SURGEON HAD NO CHOICE BUT TO USE THE 48/32 FACE CHANGE LINER THAT WAS READY TO BE USED BECAUSE THE SURGEON HAD REMOVED THE CUP ONCE AFTER IMPLANTING THE REAL LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OVER 30 MINUTES. THE PATIENT HAS OSTEOPOROSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597748 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED (DATE OF THE PRIMARY SURGERY AND THE REMOVAL SURGERY WERE UNKNOWN) DUE TO THE INFECTION. THE SURGEON IMPLANTED CEMENT SPACER INTO THE PATIENT¿S BONE. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7596077 ↗