MDM 626-00-46FRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 04546540666024), received between Mar 29, 2017 and Dec 17, 2025 — classified as 61 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (31 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Degraded; Degraded

  ADDITIONAL INFORMATION RECEIVED 25-MAR-26, "THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION HIP SURGERY "[ON (b)(6) 2026]" FROM A PRIMARY HIP TO AN FDA AND IRB APPROVED STRYKER COMPASSIONATE USE PSS DEVICE. THE PATIENT'S PELVIS WAS REPORTED AS FRACTURED, AND IT REQUIRED THIS DEVICE ALONG WITH MULTIPLE SCREWS AND A RESTORATION MODULAR FEMORAL HIP STEM TO RESTORE STABILITY TO THE JOINT."

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Periprosthetic fracture

  MAUDE report 23829951 ↗
• InjuryJun 25, 2025Corroded; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Corroded; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. THE FOLLOWING WERE OBSERVED OR REPORTED BY THE SURGEON INTRA-OP: BLACK TISSUE IN THE PATIENT. BLACK MATERIAL ON THE MDM METAL LINER ON THE SIDE THAT FACES THE SHELL. THE MDM LINER WAS LOOSE INSIDE THE SHELL. ONE OF THE THREE SCREWS IN THE SHELL WAS SITTING PROUD, SURGEON REPORTED THIS WAS THE LIKELY CAUSE OF THE LINER BEING LOOSE. THE SCREW DID NOT APPEAR TO BE CROSS-THREADED OR WORN. THE BONE GRAFT BEHIND THE SHELL HAD NOT FULLY INCORPORATED INTO THE ACETABULUM, CAUSE THE SHELL TO NOT BE OPTIMALLY SEATED. THE SHELL, SCREWS, MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD WERE REVISED TO A MULTIHOLE SHELL WITH AUGMENTS AND SCREWS, A POLY LINER, AND A 40MM FEMORAL HEAD.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 22325995 ↗
• InjuryMar 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PT DISLOCATED THR WITH MDM WHICH ALSO DISSOCIATED. STEM ALSO REMOVED AND ANTEVERTED 10° AND REINSERTED. THE ADM POLY INSERT SEPARATED FROM THE MDM METAL LINER AND THE FEMORAL HEAD SEPARATED FROM THE ADM POLY INSERT. THE METAL LINER WAS NOT REVISED. THE STEM WAS REVISED AS THE VERSION NEEDED ANTEVERTING BY 10 DEGREES TO PREVENT FURTHER DISLOCATIONS. A NEW EXETER STEM WAS IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 21593125 ↗
• InjuryFeb 26, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER THE FOLLOWING SERIES OF EVENTS: PATIENT FELL 4 DAYS POST-OP AND DISLOCATED. A CLOSED REDUCTION WAS PERFORMED. AN X-RAY TAKEN AFTER THE CLOSED REDUCTION DIDN'T 'LOOK RIGHT,' AND AN OPEN REDUCTION WAS PERFORMED. IT WAS OBSERVED THAT THE POLY INSERT WAS FLOATING IN THE JOINT - IT WAS OFF OF THE FEMORAL HEAD AND OUT OF THE METAL LINER (IT IS NOT KNOWN WHICH SEPARATION OCCURRED FIRST). A NEW FEMORAL HEAD AND ADM/ MDM POLY INSERT WERE IMPLANTED. THE ORIGINAL POLY AND FEMORAL HEAD WERE RE-ASSEMBLED AT THE BACK TABLE TO DEMONSTRATE TO THE SURGEON THE FORCE NEEDED TO ASSEMBLE THE IMPLANTS. THE REP PROVIDED PICTURES SHOWING THE POLY INSERT BEING DISLOCATED AND DISSOCIATED. THE SURGEON WOULD LIKE THIS EVENT AND DEVICES INVESTIGATED, AND WOULD LIKE THE INVESTIGATION RESULTS. THE DEVICES ARE AVAILABLE FOR RETURN, AND THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 21467586 ↗
• InjuryFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISED A RIGHT HIP LINER AND HEAD DUE TO THE MDM METAL LINER DISENGAGING FROM THE SHELL AND OVERALL INSTABILITY. HE TIGHTENED ONE OF THE ACETABULAR SCREWS A COUPLE OF TURNS AND RE-IMPLANTED A NEW MDM LINER AND WENT FROM A -4MM HEAD TO A +12MM HEAD.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21464835 ↗
• InjurySep 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PT CALLED AND WANTED TO KNOW IF THE IMPLANTS HAD COBALT / ANY RECALLS. HAD A TOTAL HIP REPLACEMENT A YEAR AGO. ADDITIONAL INFO. 22-8-2024: HIGH COBALT LEVELS.

  Patient problems: Metal Related Pathology

  MAUDE report 20235868 ↗
• InjuryMar 22, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  LEFT TOTAL HIP. THE REVISION TODAY WAS SECONDARY TO A FALL IN WHICH THE CERAMIC HEAD WAS DISASSOCIATED FROM THE POLY MDM INSERT. THIS DISASSOCIATION WAS DISCOVERED PREOP ON CT. IN SURGERY IT WAS FOUND THAT THE STEM WAS IMPINGING ON THE CUP POSTERIOR SUPERIOR AND HAD CAUSED A SMALL NOTCH ON THE NECK OF THE FEMORAL IMPLANT. THE 28MM HEAD AND INSERT WERE REMOVED. A +0 HEAD SEAMED TO ELIMINATE THE IMPINGEMENT PROBLEM AND STABILIZE THE JOINT. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Fall; Joint Dislocation; Pain

  MAUDE report 18957861 ↗
• InjuryMar 15, 2024Degraded; Degraded

  DR. REVISED AN MDM LINER DONE IN 2020. DR STATED LINER WAS DOWN BUT PRESENTED METALLOSIS BEHIND LINER AND PATIENT HAD HIGH LEVELS OF METAL IN SYSTEM.

  Patient problems: Metal Related Pathology

  MAUDE report 18910694 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT TOTAL HIP. THE REVISION WAS TO PLACE A FEMORAL STEM (PATIENT PREVIOUSLY HAD A GIRDLESTONE PROCEDURE PERFORMED IN A PRIOR REVISION). A MULTIHOLE CUP HAD BEEN PLACED PREVIOUSLY AND REMAINED IN. THE MDM INSERT WAS REMOVED FROM THE CUP AND A CONSTRAINED LINER WAS PLACED WITH A REST MOD STEM AND HEAD. A CABLE WAS ALSO PLACED PRIOR TO STEM INSERTION TO PREVENT FRACTURE. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 18462787 ↗
• InjuryOct 13, 2023Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. 2 MONTHS POS-OP, PATIENT COMPLAINT OF INCREASING PAIN. APPROXIMATELY 1 MONTH PRIOR TO REVISION, INCREASED ION LEVELS WERE DETECTED. INTRA-OPERATIVELY, CORROSION WAS NOTED ON THE MDM METAL LINER BETWEEN THE METAL LINER AND THE SHELL.

  Patient problems: Pain

  MAUDE report 17928629 ↗
• InjuryAug 9, 2023Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT VOICEMAIL ON PATIENT HOTLINE REPORTING A REVISION DUE TO PAIN AND "CORRODED METAL ON METAL" WITH HIS RIGHT STRYKER DUAL MOBILITY HIP. UPDATE: "...METALLOSIS, OSTEOLYSIS. MY BONE WAS DECOMPOSING. I HAD TO HAVE THE HIP REVISED."

  Patient problems: Ambulation or Postural Difficulties; Fibrosis; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 17486127 ↗
• InjuryJul 18, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. AN ADM/ MDM POLY INSERT, MDM METAL LINER, CERAMIC HEAD AND SLEEVE AND 2 SCREWS WERE REVISED TO A CONSTRAINED LINER AND NEW FEMORAL HEAD. REP CONFIRMED THAT INTRA-OPERATIVELY NO IMPLANTS WERE NOTED TO BE WORN, LOOSE, OR DAMAGED.

  Patient problems: Joint Laxity

  MAUDE report 15046654 ↗
• InjuryJun 20, 2022Unstable; Unstable

  PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Joint Laxity

  MAUDE report 14750388 ↗
• InjuryJun 19, 2022Degraded; Unstable; Degraded; Unstable

  AS REPORTED IN MEDWATCH: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022. ADDITIONAL INFORMATION REPORTED: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Laxity; Metal Related Pathology; Pain

  MAUDE report 14741219 ↗
• InjuryJun 17, 2022Material Erosion; Material Erosion

  AS REPORTED: "EXPLANTED MDM CUP/ LINER AND ACCOLADE STEM AND HEAD. REPLACED WITH NEW MDM CUP AND LINER AND RESTORATION MODULAR STEM / CONE BODY AND HEAD. NO MORE INFORMATION GIVEN OUT BY HOSPITAL/ SURGEON." SPOKE TO REP. REP WAS NOT MADE AWARE OF ANY PATIENT COMPLAINTS OR OTHER CAUSE FOR REVISION. HOWEVER, INTRAOPERATIVELY IT WAS NOTED THAT THE CERAMIC HEAD WORE THROUGH THE ADM/ MDM POLY INSERT AND THE MDM METAL LINER. REP PROVIDED EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 14734684 ↗
• InjuryJun 16, 2022Material Erosion; Material Erosion

  I WAS IN A DEEP SQUAT, ONE I HAD DONE MANY TIMES BEFORE, AND MY IMPLANT FAILED AND SLIPPED OUT OF THE SOCKET. UPDATE PER CONVERSATION WITH PATIENT 05/25/2022: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2022, PATIENT WAS IN A "DEEP SQUAT" AND THE LEFT HIP "FELL OUT TO THE BACK". PATIENT NOTED THAT PRIOR TO REVISION, SURGEON INDICATED POTENTIAL "STEM HITTING CUP AND LINER BREAKAGE" (PATIENT IS UNSURE IF LINER WAS METAL OR POLY). PATIENT ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT. PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2022. PATIENT HAS NOT RETURNED TO SURGEON YET FOR FOLLOW UP AND IS UNSURE AT THIS TIME WHAT PARTS WERE REVISED. PATIENT WILL SUPPLY MEDICAL RECORDS. UPDATE 13/JUNE/2022 WG: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION IN 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY IN 2022.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 14710817 ↗
• InjuryFeb 7, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  HEAD LINER EXCHANGE TO F 44MM X3, -2.5 44MM BIOLOX. EXPLANTED 626-00-46F LOT 80101203. PATIENT STARTED COMPLAINING 6 MONTHS AGO. ELEVATED IONS. PATIENT WAS HAVING PAIN.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 13474327 ↗
• InjuryDec 20, 2021Material Erosion; Mechanical Problem; Material Erosion; Mechanical Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6), 2014 AND WAS REVISED ON (B)(6), 2021. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. *UPDATE ON (B)(6) 2021 PER CLINICIAN REVIEW: (B)(6) 2021: OPERATIVE NOTE SOME METALLOSIS IN HIP, SOME IMPINGEMENT OF THE POSTERIOR NECK ON THE MDM LINER CONFIRMATION: A REVISION SURGERY WAS PERFORMED. IMPINGEMENT NOTED AT THE TIME OF REVISION WITH NOTCHING OF THE NECK.

  Patient problems: Loss of Range of Motion; Metal Related Pathology

  MAUDE report 13043006 ↗
• InjuryDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A POST-OP X-RAY TAKEN THE SAME DAY AS THE PRIMARY HIP REPLACEMENT INDICATED DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED AND FAILED, AND THE PATIENT WAS REVISED THE SAME DAY. DURING THE REVISION, THE ADM/ MDM POLY INSERT WAS FOUND FLOATING IN THE JOINT. THE 46F ADM/ MDM POLY INSERT AND 28+0 BIOLOX HEAD WERE REVISED TO ANOTHER 46F ADM/ MDM INSERT AND 28 +4 BIOLOX HEAD. INTRAOPERATIVELY, THE BIOLOX HEAD WAS STILL ATTACHED TO THE STEM TRUNNION.

  Patient problems: Joint Dislocation

  MAUDE report 13029576 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT HIP WAS REVISED. A 10¿ 36MM ECCENTRIC F INSERT WAS IMPLANTED. UPDATE 07/NOVEMBER/2018: PER REP., PATIENT REVISED DUE TO AN ISSUE WITH THE FEMORAL STEM, WHICH WAS FOUND TO BE NOTCHED ON THE NECK. AN ACCOLADE TMZF STEM, 28 -4 HEAD (COMPOSITION UNKNOWN), AND MDM/ ADM LINER CONSTRUCT WERE REVISED TO A COMPETITOR STEM AND HEAD WITH A 10¿ 36MM ECCENTRIC F INSERT. REP PROVIDED AN X-RAY AND EXPLANT PICTURES AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICIAN NOTED THE FOLLOWING; THE CHOICE OF A 28/MINUS-4 HEAD IN AN MDM CONSTRUCT INCREASES THE LIKELIHOOD OF NECK IMPINGEMENT WITH THE RESULTING NOTCH PRODUCTION ON THE FEMORAL NECK. THERE IS NO EVIDENCE THIS CLINICAL SITUATION WAS THE RESULT OF FACTORS ASSOCIATED WITH IMPLANT MANUFACTURING OR MATERIALS. UPDATE 20 DECEMBER 2018: UNKNOWN BONE SCREW ADDED TO THE PRODUCT GRID, A CLINICIAN REVIEW HAS STATED THAT "THE RIGHT HAS ONE SCREW IN THE ACETABULUM, WHICH IS LARGER THAN THE ACETABULUM ON THE LEFT, AND IS PROTRUDING THROUGH THE ME

  Patient problems: Metal Related Pathology

  MAUDE report 12540345 ↗
• InjurySep 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "REVISION OF LEFT ACETABULAR COMPONENT. SURGEON STATES PATIENT IS PHYSICALLY ACTIVE AND PRESENTED WITH PAIN AND FRACTURE OF ACETABULUM. SURGEON STATES SIGNIFICANT ADVERSE LOCAL TISSUE REACTION NOTED DURING SURGERY. SURGEON STATES CUP WAS WELL FIXED." SPOKE TO REP. REP CONFIRMED PATIENT IS VERY PHYSICALLY ACTIVE (WATERSKIING, 72-HOLE GOLF, GYM, ETC). INTRA-OPERATIVELY, THE SURGEON CONFIRMED THAT THE MDM METAL LINER WAS WELL FIXED AND WELL POSITIONED IN THE SHELL. SURGEON ALSO CONFIRMED THERE WAS NO IMPINGEMENT ON THE FEMORAL STEM, AND COULD NOT PROVIDE ANY POSSIBLE CAUSE OR CONTRIBUTOR TO ALTR. A SHELL WITH DOME HOLE PLUG, MDM METAL LINER, ADM/ MDM POLY INSERT, AND V40 BIOLOX CERAMIC HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED POLY INSERT OR CERAMIC HEAD. REP PROVIDED IMAGING AND PRIMARY IMPLANT REPORT AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Foreign Body Reaction

  MAUDE report 12495369 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT ALLEGEDLY HAD SUFFERED INJURIES/COMPLICATIONS FROM A FAILED HIP REPLACEMENT PART. UPDATE BASED ON MED REVIEW: RIGHT TOTAL HIP REPLACEMENT REVISION WITH FEMORAL CERAMIC HEAD EXCHANGE WITH A SLEEVE, AS WELL AS ACETABULAR COMPONENT REVISION" FOR A DIAGNOSIS OF "FAILED LINER WITH PARTIAL DISLOCATION OF RIGHT TOTAL HIP AND METALOSIS". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A POSTERIOR APPROACH. THE REPORT NOTES, " LARGE AMOUNT OF HETEROTOPIC BONE POSTERIORLY EVENTUALLY ABLE TO DISLOCATE FEMORAL HEAD REMOVED CERAMIC HEAD LINER HAD BEEN DISPLACED ANTERIORLY AND DISLOCATED THIS HAD LED TO METALOSIS SIGNIFICANT WEAR ON THE CERAMIC HEAD ONTO THE METAL EDGE POLYETHYLENE DUAL MOBILITY LINER WAS REMOVED WITH SOME EFFORT METALLIC SLEEVE HAD SOME SCRATCHES. THE RIGHT HIP DEMONSTRATES THREE SCREWS IN THE ACETABULUM, A RESTORATION MODULAR STEM WHICH APPEARS SUBSIDED, AND A SMALLER MODULAR HEAD WHICH APPEARS TO BE SUPERIORLY MIGRATED IN AN MDM LINER.

  Patient problems: Inflammation; Joint Dislocation; Pain

  MAUDE report 12133395 ↗
• InjuryJun 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE ADM/MDM INSERT AND THE MDM LINER. THE PATIENT WAS REVISED TO A TRIDENT CONSTRAINED INSERT WITH A NEW CERAMIC C-TAPER FEMORAL HEAD AND ADAPTER SLEEVE. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR ADAPTER SLEEVE. NO REP WAS PRESENT FOR THE PROCEDURE AND NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 11997545 ↗
• InjuryApr 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PT. PRESENTED AFTER MULTIPLE DISLOCATIONS OF AN MDM (RIGHT) TOTAL-HIP, DUE TO HETEROTOPIC-BONE-GROWTH/OSTEOPHYTE-CAUSED IMPINGEMENT AROUND THE ACETABULUM. SURGEON REMOVED EXCESS HETEROTOPIC-BONY-STRUCTURES, THEN CHANGED THE FEMORAL HEAD AND MDM COMPONENTS AS PART OF HIS PROTOCOL FOR THIS SORT OF REVISION...SURGEON OPTED TO USE A FEMORAL HEAD THAT MATED WITH THE STEM'S V40 TAPER INSTEAD OF USING ANOTHER 'V40/ C-TAPER SLEEVE'". SPOKE TO REP. DUE TO HETEROTOPIC BONE GROWTH, IMPINGEMENT WAS BEING CAUSED DURING CERTAIN POINTS OF MOVEMENT, LEVERING THE ADM/ MDM POLY OUT OF THE MDM METAL LINER. AFTER REMOVING THE IMPINGING BONE GROWTH, THE ADM/ MDM POLY INSERT, 28 +0 C-TAPER HEAD, AND ADAPTER SLEEVE WERE REVISED TO ANOTHER ADM/ MDM POLY INSERT (SAME CATALOG NUMBER) AND 28 +0 V40 CERAMIC HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND SLEEVE, PROVIDED THE REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 11616216 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE ADM/MDM POLY INSERT FROM THE MDM METAL LINER. A 28/52 46F ADM/MDM INSERT AND 28+0 MM BIOLOX CERAMIC V40 HEAD WERE REVISED TO A ANOTHER ADM/MDM INSERT OF THE SAME SIZE AND A 28+0 MM BIOLOX CERAMIC C-TAPER HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 11590104 ↗