Trident 623-00-44GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327025385), received between Jun 14, 2017 and Nov 16, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2022Material Erosion; Detachment of Device or Device Component; Naturally Worn; Material Erosion; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR AND HEAD DISSOCIATION. INTRA-OPERATIVELY, IT WAS DISCOVERED THE TRUNNION DUG THROUGH THE LINER AND WAS ARTICULATING AGAINST THE SHELL, CAUSING ADDITIONAL WEAR. METALLOSIS WAS ALSO NOTED. THE STEM, HEAD, AND LINER WERE REVISED. REP CAN PROVIDE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 15805913 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN AN EMAIL RECEIVED BY THE REP FROM A SURGEON: "BELOW IS AN IMPLANT RECORD FOR A V40 FEMORAL HEAD THAT I WANT TO VERIFY WHETHER WAS RECALLED OR NOT. THE PATIENT IS NOT ON OUR RECALL LIST BUT THE SURGEON WHO HAS SINCE RETIRED NOTIFIED THE PATIENT THAT SHE DID HAVE A RECALLED HEAD BUT THERE IS DISCREPANCY IN OUR RECORDS. I'M SEEING THIS PATIENT NOW FOR (RIGHT) HIP PAIN YET ANOTHER SURGEON HAS OFFERED A REVISION ON THE BASIS OF THE PATIENT REPORTING THAT HER HEAD WAS RECALLED." SPOKE TO REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON AT THIS TIME.

  Patient problems: Pain

  MAUDE report 11677650 ↗
• InjuryMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT HEAD AND LINER EXCHANGE; PER ATTENDING MD, PATIENT SUFFERED FROM GENERAL DISCOMFORT/ PRESSURE AND GROIN PAIN. UPDATE: "RIGHT SIDE".

  Patient problems: Discomfort; Injury; Pain

  MAUDE report 8649460 ↗
• InjuryApr 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. REP REPORTED THERE WERE THREE GELATINOUS MASSES ON THE PATIENT'S HIP WHICH EXTENDED DOWN TO THE STEM (NOT REPORTED AS PSUEDOTUMOR). FLUID COULD NOT BE EXTRACTED FROM THE MASSES PRE-REVISION, TISSUE WAS SENT TO BE EXAMINED. NO BLACK TISSUE WAS NOTED IN THE PATIENT'S JOINT. NO BLACK MATERIAL/ CORROSION WAS NOTED AT THE HEAD/ TRUNNION INTERFACE. NO TRUNNION WEAR WAS NOTED. PATIENT FACTOR: LYMPHOMA WITHIN THE PAST YEAR. PATIENT'S FEMORAL HEAD AND LINER WERE REVISED TO A V40 +4 SLEEVE, 44 BIOLOX HEAD, AND THE SAME CATALOG NUMBER LINER (DIFFERENT LOT). UPDATE (B)(6) 2019: MATERIAL ANALYSIS NOTED THE FOLLOWING: EDS SHOWED THE HEAD WAS CONSISTENT WITH ASTM F1537 AND THE DEBRIS ON THE INTERIOR TAPER WAS CONSISTENT WITH AN OXIDE, A CORROSION PROCESS, AND BIOLOGICAL MATERIAL. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED.

  Patient problems: Calcium Deposits/Calcification; Injury

  MAUDE report 8470417 ↗
• InjurySep 17, 2018Material Deformation; Material Deformation

  SURGEON REVISED A STEM, HEAD, AND LINER DUE TO TRUNNIONOSIS. ORIGINAL SURGERY WAS (B)(6) 2007. UPDATE 23/AUGUST/2018: REP PROVIDED EXPLANT PICTURES, PRE-REVISION X-RAYS, PRIMARY OPERATIVE REPORT, AND USAGE SHEETS FROM PRIMARY AND REVISION PROCEDURES. EXPLANT PICTURE SHOWS WEAR ON THE RIM OF THE POLY INSERT AND PRE-REVISION X-RAYS SHOW THE HEAD DISASSOCIATED FROM THE STEM.

  Patient problems: Injury

  MAUDE report 7883143 ↗
• InjuryJun 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, PATIENT'S LEFT HIP WAS REVISED. AS PER THE SALES REP, THE PATIENT WAS REVISED DUE TO AN ACETABULAR FRACTURE. IT IS UNKNOWN WHY IT FRACTURED. THEY TOOK OUT THE LINER. THE CUP WAS STILL STABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6639661 ↗