Trident 508-11-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540432186), received between Sep 23, 2018 and Feb 5, 2020 — classified as 2 injuries, 1 malfunction.

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 16, 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.

• MalfunctionFeb 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MDM LINER DOESN'T SEEM TO LOCK UP ENOUGH IN POST-OPERATIVE X-RAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671650 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ABOUT 5 YEARS BEFORE, MDM AND ACCOLADE2 WAS IMPLANTED. ALTHOUGH THE TIMING WAS UNDECIDED, WHEN A PATIENT VISITED THE HOSPITAL, THERE WAS INFLAMMATION SUSPECTED OF ARMD/ALVAL. CURRENTLY UNDER OBSERVATION.

  Patient problems: Inflammation; Reaction

  MAUDE report 8379175 ↗
• InjurySep 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  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 DECEMBER 1, 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." "ON (B)(6) 2009 A RIGHT HIP WOUND REVISION WITH INCISION AND DRAINAGE AND INSERTION OF AN ANTIBIOTIC SPACER WAS PERFORMED FOR AN INFECTED GIRDLESTONE WITH CHRONIC OSTEOMYELITIS AND PARTICLE DISEASE OF THE RIGHT HIP." [...] "ON DECEMBER 8, 2009 REMOVAL OF THE ANTIBIOTIC SPACER AND CONVERSION TO A TOTAL HIP ARTHROPLASTY WAS

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 7900655 ↗