Advantim 18080300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684180803001), received between Sep 20, 2019 and Sep 14, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Break; Loss of Osseointegration; Break; Loss of Osseointegration

  ALLEGEDLY, ON (B)(6) 2012, PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HIS BODY IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY (THA). PATIENT'S (B)(6) 2012 HIP IMPLANT SURGERY WAS PERFORMED AT GEISINGER BLOOMSBURG HOSPITAL, BLOOMSBURG, PENNSYLVANIA. AFTER HIS INITIAL RECOVERY FROM THE (B)(6) 2012, HIP SURGERY, FOR SEVERAL YEARS PATIENT'S WRIGHT MEDICAL ARTIFICIAL HIP PERFORMED AS EXPECTED, AND THE PAIN AND DISABILITY PATIENT HAD EXPERIENCED IN HIS RIGHT HIP PRIOR TO HIS (B)(6) 2012, HIP REPLACEMENT SURGERY HAD BEEN SUBSTANTIALLY RELIEVED. ON OR ABOUT (B)(6) 2020 PATIENT WAS TOLD THAT HE SUFFERED A BROKEN SCREW HOLDING THE DYNASTY CUP, LEADING TO MECHANICAL LOOSENING OF THE CUP AND RIGHT HIP PAIN, AND THAT IT WAS ADVISABLE THAT HE UNDERGO SURGERY TO REMOVE THE DYNASTY CUP AND SCREWS AND REPLACE AND REFIX THE CUP AND FIXATION SCREWS(IT IS NOT INDICATED WHICH SCREW WAS BROKEN SINCE PATIENT HAD 3 SCREWS IMPLANTED. ALSO, IT HAS NOT BEEN INDICATED WHICH CUP AND SCREWS WERE USED TO REPLACE THE DYNASTY CUP AND SCREWS). WHILE REPLACING THE AFOREMENTIONED CUP ON (B)(6) 2020, SURGEON OBSERVED THAT THE PROFEMUR®PLUS COCR MODULAR NECK WAS WELL CONNECTED TO THE C

  Patient problems: Pain

  MAUDE report 15417888 ↗
• InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE ACETABULAR COMPONENT WAS INSERTED AS A REVISION FOR A PREVIOUSLY MIGRATED PROCOTYL L SHELL. REVISION COMPONENT INSERTED IN ROUTINE FASHION AND SECURED WITH 3X SCREWS. SHELL INSERTION AND SCREW INSERTION APPEARED SECURE AT COMPLETION OF PROCEDURE. PATIENT SEEN IN ROUTINE FOLLOW UP CLINIC AT 3 MONTHS JUST 2 DAYS BEFORE READMISSION WITH FURTHER MIGRATION OF REVISION ACETABULAR COMPONENT. PATIENT DENIES ANY TRAUMATIC EVENT. THE PREVIOUS REVISION IS CAPTURED UNDER INCIDENT GROUP (B)(4). ADDITIONAL INFORMATION: ALLEGEDLY, AS REPORTED FROM UK NJR REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15351222 ↗
• InjuryMar 11, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT THR. X RAYS SHOWED LOOSE AND DISLODGED CUP. UNDERWENT THE REVISION SURGERY ON (B)(6) 2020 WHERE THE MPO 28 MM FEMORAL HEAD WAS UP-SIZED TO A 36MM. MPO BONE SCREWS WERE CHANGED FROM 1.5 CM AND 2.5 CM TO A 2 CM SCREW. THE MPO CUP AND LINER WERE REPLACED WITH ANOTHER MANUFACTURER IMPLANT.

  Patient problems: No Information

  MAUDE report 9821767 ↗
• InjurySep 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT PRESENTED WITH PAIN. REMOVAL OF DYNASTY CUP FOR LOOSENING. NO ACUTE INJURY OF PATIENT. MPO IMPLANTS WERE REMOVED AND REPLACED WITH ANOTHER SUPPLIERS IMPLANTS.

  Patient problems: Pain

  MAUDE report 9100712 ↗