Advantim 18080301Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684180803011), received between Aug 6, 2019 and Sep 13, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 13, 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) 18, 2012 HIP IMPLANT SURGERY WAS PERFORMED AT (B)(6) HOSPITAL, (B)(6). 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 CONSERVE® NECK SLEEVE, BUT EA

  Patient problems: Pain

  MAUDE report 15414563 ↗
• 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)(6). 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 15351216 ↗
• InjuryAug 30, 2022Migration; Migration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENTS NOT REVISED: PRODUCT: PROFEMUR® L HIP STEM SIZE 5 HA COATED, PRODUCT ID: PHA05510, LOT#:1674917, QTY:1; PRODUCT: PROFEMUR® NECK A/R 8DGLONG COBALT CHROME, PRODUCT ID: PHAC1234, LOT#:1830376 QTY:1; REVISION NJR NUMBER: 4840985; SIDE:L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION ON 07/05/2022: POST OP X-RAY INDICATED THERE WAS POSSIBLY A NEED FOR REVISION. THE REVISION WAS CONDUCTED 8 (EIGHT) DAYS LATER. ACCORDING TO THE X-RAY THE PROCOTYL L WAS SPIN OUT, BUT THERE ARE NOT COPIES OF THIS X-RAY. WE RECEIVED TWO NEW PARTS WHICH BELONG TO SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 15325010 ↗
• InjuryJul 30, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  ALLEGEDLY, RIGHT LEG IS SHORT, CUP IS TOO VERTICAL, PATIENT HAS DISLOCATED 3 TIMES AND THERE IS LUCENCY AROUND THE CUP TO INDICATED THAT IT HAS POOR IN GROWTH. CUP, SCREWS/LINER/HEAD/NECK WERE PULLED. STRYKER CUP WENT IN WITH OUR HEAD AND NECK.

  Patient problems: No Information

  MAUDE report 10343519 ↗
• 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 9100713 ↗
• InjuryAug 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY THE PATIENT HAS DISLOCATED 3 TIMES, (B)(6) PA. THE ABOVE IMPLANTS WERE REMOVED FROM THE PATIENT AND REPLACED WITH STRYKERS. STRYKERS DUAL MOBILITY WAS USED WITH A 28MM + 7MM HEAD OF OURS.

  Patient problems: No Information

  MAUDE report 8865593 ↗