Trident 663-10-32DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327024838), received between Sep 21, 2018 and Dec 10, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  *THIS PI IS FOR THE RIGHT HIP. IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE HIP FAILED AND WAS REVISED ON OCTOBER (B)(6).

  Patient problems: Injury; Insufficient Information

  MAUDE report 8148500 ↗
• InjuryDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE LEFT HIP. IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE HIP FAILED AND IS SCHEDULED FOR REVISION.

  Patient problems: Injury

  MAUDE report 8148497 ↗
• InjurySep 21, 2018Material Deformation; Material Deformation

  REVIEW OF THE MEDICAL REVIEW INDICATED, "ON (B)(6) 2008 AN EXPLORATION OF THE RIGHT TOTAL HIP, INCISION AND DRAINAGE, AND VAC DRESSING APPLICATION WAS PERFORMED FOR A POST-OPERATIVE DIAGNOSIS OF EXTENSIVE METALLOSIS RIGHT HIP. THE OPERATIVE REPORT DESCRIBES A LATERAL APPROACH AND FINDINGS INCLUDING METALLOSIS OF THE RIGHT HIP AND THIGH WITH DAMAGE AND WEAR TO THE POLY LINER AND HEAD. EXTENSIVE METALLOSIS AROUND THE PROXIMAL FEMORAL COMPONENT AND BEHIND THE ACETABULAR COMPONENT WAS NOTED AND THE SURGEON DID NOT CLOSE THE FASCIA AND KEPT A SPONGE IN THE PROXIMAL FEMUR AND ACETABULUM AFTER EXPLANTING THE TOTAL HIP COMPONENTS. ON (B)(6) 2008 DEBRIDEMENT WAS PERFORMED AND A VAC SYSTEM WAS APPLIED. CULTURE WAS NOTED TO BE POSITIVE FOR METHICILLIN SENSITIVE STAPH AUREUS. WHEN SEEN ON (B)(6) 2009 SHE WAS NOTED TO BE 6-CENTIMETERS SHORT ON THE RIGHT LOWER EXTREMITY."

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 7897677 ↗