Alumina 17-3600ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327101270), received between May 31, 2018 and Jul 1, 2021 — classified as 2 injuries.

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

• InjuryJul 1, 2021Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION HIP SURGERY FOLLOWING IDENTIFICATION OF ELEVATED TI LEVELS AND A WORN (TITANIUM SLEEVE PORTION) OF A CERAMIC LINER HAD TO BE REMOVED IN ADDITION TO AN ALUMINA HEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED USING A NEW POLY LINER COUPLED WITH A C TAPER SLEEVE AND DELTA 36MM HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 12104518 ↗
• InjuryMay 31, 2018Migration or Expulsion of Device; Noise, Audible; Migration or Expulsion of Device; Noise, Audible

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT CERAMIC ACETABULAR SYSTEM. IT IS ALLEGED THAT PATIENT "HAS SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND METAL PAIN AND SUFFERING AND EXTRAORDINARY LOOSENING AND INFECTION ... AS A RESULT OF THE IMPLANTATION OF THE DEVICE, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2011. UPDATE AS PER MEDICAL REVIEW: CLINICIAN CONCLUDED, "WHILE NO PRE-OP X-RAYS ARE AVAILABLE FOR REVIEW, THE REVISING SURGEON NOTED MALPOSITION OF THE ACETABULAR COMPONENT OF THE PRIMARY TOTAL HIP ARTHROPLASTY RESULTED IN IMPINGEMENT AND SUBLUXATION OF THE CERAMIC-CERAMIC BEARING WITH A SINGLE STRIPE WEAR NOTED ON THE ALUMINA HEAD."

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7556779 ↗