Advantim 18080302Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI M684180803021), received between Jan 14, 2015 and Apr 4, 2023 — classified as 19 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2023Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT IN (B)(6) 2010 REPLACEMENT OF THE RIGHT HIP BY MEANS OF A METAL-METAL PROSTHESIS IMPLANTATION, HAS DEVELOPED PSEUDO-TUMOR FROM METAL-METAL COUPLING, WITH EVIDENCE OF A COBALT DOSAGE OF 7.7 MG / L (COMPARED TO REFERENCE <1.0MG / L), CAUSING ASEPTIC LOOSENING OF THE PROSTHESIS AND FORCING IT TO UNDERGO A PROSTHETIC REVISION IN 2014, OF INCREASED COMPLEXITY DUE TO THE PRESENCE OF THE TUMOR MASS. MORE TOOLS SINCE THE ONSET OF METALLOSIS AND, EVEN MORE SO, THE DEVELOPMENT OF PSEUDO-TUMOR REPRESENT CLEAR TYPICAL CONSEQUENCES OF METAL-METAL COMBINATIONS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: ALLEGEDLY, REPORTED THE ONSET OF LOW-GRADE FEVER, INFECTIOUS CAUSES EXCLUDED. REPORTED GROIN PAIN WITH POAS WEAKNESS FOR ABOUT 1 YEAR. A CLINICAL ANALYSIS WITH ACCEPTANCE DATE OF (B)(6) 2014 SHOWS RESULTS OF P-CHROME 0.4 UG/L AND SG-COBALT 7.7UG/L. CLINICAL RECORDS SHOWED THAT THE DATE OF THE INTERVENTION FOR REVISION SURGERY WAS ON (B)(6) 2014. A MUSCLE-TENDON ULTRASOUND WITH DATE OF (B)(6) 2014 FOR THE RIGHT HIP, A CT PELVIS/SACROILIAC WITH DATE OF (B)(6) 2014 FOR THE RIGHT HIP AND OTHER STUDIES ARE FOUND FROM PAGES NUMBER 71 TO 77 IN THE FILE "DOC. 05 CARTELLA

  Patient problems: Pain

  MAUDE report 16678229 ↗
• InjuryNov 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT DISLOCATED 1-2 WEEKS AFTER SURGERY THE SOFT TISSUES WERE VERY LAX REQUIRED ZIMMER CONSTRAINED.

  Patient problems: Failure of Implant

  MAUDE report 15824553 ↗
• 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 (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 EASILY

  Patient problems: Pain

  MAUDE report 15417619 ↗
• 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 ON 18 AUG. 2022: ALLEGEDLY, AS REPORTED FROM (B)(6) REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15351240 ↗
• InjuryAug 16, 2022Corroded

  ALLEGEDLY, THE PATIENT ON (B)(6) 2020 HAD A LEFT REVISION SURGERY DUE TO CORROSION, ON (B)(6)2020 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION ON THE SIDE LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 15233292 ↗
• InjuryDec 22, 2021Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT HAS PAIN AND LOOSENING.

  Patient problems: Pain

  MAUDE report 13061250 ↗
• InjuryDec 22, 2021Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT HAS PAIN AND LOOSENING.

  Patient problems: Pain

  MAUDE report 13061187 ↗
• InjuryDec 16, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT DISLOCATED A FEW DAYS AFTER THE ORIGINAL SURGERY, X-RAYS SHOWED THAT THE CUP HAD ?SPUN OUT? TAKING THE SCREW WITH IT OUT OF THE ACETABULUM. THE SHELL WAS REVISED FOR A ZIMMER CONTINUUM SHELL WITH 3 SCREWS. A NEW MICROPORT FEMORAL HEAD WAS USED. THE PATIENT MAY HAVE PERFORMED AN MOVEMENT BEYOND WHAT WAS ADVISED FOR PATIENTS IMMEDIATELY AFTER A THR.

  Patient problems: Insufficient Information

  MAUDE report 13017537 ↗
• InjurySep 29, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, A PATIENT WAS REVISED FOR CUP LOOSENING. THE ACETABULAR COMPONENT IS PROCOTYL L. COMPONENTS NOT REVISED: PROFEMUR(R) PROXIMAL BODY PART ID: PPW39104 ,LOT NUMBER: X02400249; PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED PART ID: PPW38023 ,LOT NUMBER: X03398438; PROFEMUR® MODULAR FEMORAL NECK PART ID:PHA01212, LOT NUMBER: V09243858.

  Patient problems: Insufficient Information

  MAUDE report 12551114 ↗
• InjurySep 23, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO LINER WEAR, DISASSOCIATION, CUP LOOSENING, AND METALLOSIS FROM METAL-ON-METAL CONTACT WITH THE FEMORAL HEAD AND ACETABULAR COMPONENT. (RIGHT HIP).

  Patient problems: Insufficient Information

  MAUDE report 12519946 ↗
• InjuryAug 29, 2021Loss of Osseointegration; Loss of Osseointegration

  SADE # (B)(4). ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN AND LOOSENING. TROCHANTERIC NON-UNION DUE TO INADEQUATE REATTACHMENT AND OR EARLY WEIGHT BEARING. HE HAS HAD LACK OF INGROWTH OF THE ACETABULAR COMPONENT. OPERATIVE SIDE: RIGHT. THE DYNASTY BIOFAM SHELL, DYNASTY A-CLASS POLYLINER, AND SCREWS WERE REVISED. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR® NECK A/R 8DG SHORT COBALT CHROME CATALOG NUMBER: PHAC1232. LOT NUMBER: 1407107. PRODUCT NAME: PROFEMUR® GLADIATOR® CEMENTED STEM SZ 4 CATALOG NUMBER: RGLCM04. LOT NUMBER: 1453286. PRODUCT NAME: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 36MM CATALOG NUMBER: 38AM3604. LOT NUMBER: 1452346.

  Patient problems: Pain

  MAUDE report 12381672 ↗
• InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN AND LIMB LENGTH DISCREPANCY IN HER RIGHT HIP. ALL PRODUCTS WERE REPLACED.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 10751223 ↗
• 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 10343477 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , PATIENT REVISED DUE TO UNKNOWN FAILURE.

  Patient problems: No Information

  MAUDE report 9874430 ↗
• 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 9821756 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBJECT WAS SEEN IN EMERGENCY ROOM WITH RIGHT HIP PAIN FOR 2 WEEKS, CRUNCHING WITH MOTION AND DIFFICULTY AMBULATING. LINER FRACTURE WAS CONFIRMED BY X RAY AND CT OF THE HIP. SUBJECT HAD A REVISION AND REMOVAL OF THE ORIGINAL ACETABULAR, LINER, MODULAR NECK AND FEMORAL HEAD AND WAS DISCHARGED ON (B)(6) 2015.

  Patient problems: Pain

  MAUDE report 9813980 ↗
• InjuryOct 16, 2019Fracture; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO MULTIPLE HIP DISLOCATIONS, HAVING A FAILED ACETABULAR. (RIGHT) ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: SAE# S050-003R001 ALLEGEDLY, PERIPROSTHETIC FRACTURE OF THE ACETABULAR COMPONENT PATIENT WAS SEEN IN CLINIC POST SX BETWEEN (B)(6) 2013. IMPROVEMENTS WERE SLOW AND THE PATIENT WAS NOT FULLY WEIGHT BEANING. PATIENT WAS FOUND TO HAVE A FAILED ACETABULAR ON (B)(6) 2013, AND THE PATIENT UNDERWENT A REVISION WITH CAGE RECONSTRUCTION.

  Patient problems: Bone Fracture(s); Hip Fracture; No Information

  MAUDE report 9199991 ↗
• 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 9100717 ↗
• InjuryJan 14, 2015Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION (RIGHT).

  Patient problems: Unspecified Infection

  MAUDE report 4418702 ↗