MDM 626-00-48GRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540666031), received between Dec 18, 2018 and Dec 9, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  REVISION HIP SURGERY FOR CHRONIC PAIN AND POPPING. FLUID COLLECTION SEEN ON ULTRASOUND. WHITE NECROTIC TISSUE WAS VISIBLE IN AND AROUND HIP.

  Patient problems: Foreign Body Reaction; Necrosis; Pain

  MAUDE report 20887933 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. PATIENT ORIGINALLY PRESENTED WITH REPORT OF KNEE PAIN (PATIENT DOES NOT HAVE ANY KNEE IMPLANTS). X-RAYS SHOWED THAT THE COMPETITOR FEMORAL HEAD HAD BROKEN INTO MULTIPLE PIECES. AS A RESULT, THE TRUNNION OF THE COMPETITOR STEM WORE THROUGH THE STRYKER ADM/ MDM POLY INSERT, AND WAS ARTICULATING AGAINST THE MDM METAL LINER. THIS CAUSED THE PATIENT TO COMPENSATE THEIR GAIT, WHICH CAUSED THE KNEE PAIN. THE MDM LINER, ADM/ MDM POLY INSERT, AND COMPETITOR CERAMIC HEAD WERE REVISED TO ANOTHER MDM METAL LINER, ADM/ MDM POLY INSERT, AND COMPETITOR FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19220483 ↗
• InjuryApr 11, 2024Degraded; Degraded

  TOTAL HIP REVISION. ACETABULAR CUP, MDM LINER AND MDM INSERT. UPDATE PER MEDICAL RECORDS RECEIVED: THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT AND METALLOSIS.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 19090654 ↗
• InjuryJul 8, 2022Device 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. PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 14961172 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SURGEON CONTACT ME REPORTING SUSPECTED METALOSIS AND SOFT TISSUE ABNORMALITY." PATIENT WAS REVISED.

  Patient problems: Foreign Body Reaction

  MAUDE report 12325113 ↗
• InjuryOct 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON MEDICAL REVIEW: "ON EXAM A LARGE SUBCUTANEOUS HEMATOMA/ SEROMA WAS NOTED, AND IT WAS ASPIRATED FOR 200 CC OF BLOODY FLUID.

  Patient problems: Aspiration/Inhalation; Hematoma

  MAUDE report 10611776 ↗
• InjurySep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED IN A COMPETITOR DEVICE EXPERIENCE REPORT: "STRYKER MDM HEAD DISLOCATED FROM CUP." UPDATE 20/AUGUST/2020: SPOKE TO STRYKER REP. PATIENT WENT TO EMERGENCY ROOM AND A CLOSED REDUCTION WAS ATTEMPTED AND FAILED. INTRA-OPERATIVELY, THE ADM/ MDM POLY INSERT WAS FOUND TO BE OUT OF THE METAL LINER, AND THE COMPETITOR FEMORAL HEAD WAS OUT OF THE POLY INSERT. IT IS UNCLEAR IF THE CLOSED REDUCTION CAUSED OR CONTRIBUTED TO THE DISLOCATION AND DISSOCIATION. REP PROVIDED CATALOG AND LOT CODES OF THE REVISED DEVICES AND PATIENT DOB, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10507939 ↗
• InjuryJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. IN COMPARISON WITH THE PRIMARY USAGE SHEET, A 28 +4 METAL FEMORAL HEAD, MDM METAL LINER AND ADM/ MDM POLY INSERT WERE EXPLANTED, AND A CONSTRAINED LINER WITH 28 +4 METAL HEAD WERE IMPLANTED. A 40MM SCREW ALSO APPEARS TO HAVE BEEN IMPLANTED (1 EACH OF 20MM AND 30MM SCREWS WERE IN SITU). THE REASON FOR REVISION: THE PATIENT HAD DISLOCATED ENTERING A SMALL VEHICLE.

  Patient problems: Injury

  MAUDE report 10307921 ↗
• InjuryJun 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED ANTERIORLY (ON (B)(6)) FOLLOWING A REVISION HIP REPLACEMENT. REVISION WAS ON (B)(6) 2020, TO REMOVE A MITTLEMEIER TYPE SCREW IN CUP (SMITH & NEPHEW BRAND). THERE WAS A LOT OF OSTEOLYSIS BEHIND THE CUP & CUP WAS REVISED TO A TRITANIUM REVISION SHELL WITH MDM. ON STANDBY AT THIS REVISION ON (B)(6) WAS A SMITH AND NEPHEW CAGE AND A CONSTRAINED CEMENTED CUP (STRYKER). THE DOCTOR DECIDED NOT TO USE THE CAGE AND CONSTRAINED CUP, STATING THAT THE HIP FELT STABLE WITH THE TRITANIUM AND MDM CONSTRUCT. LATE ON THE NIGHT OF (B)(6), I RECEIVED A CALL TO SAY THAT PATIENT WAS DISLOCATING & THEY WERE GOING TO REVISE TO A CAGE. TRITANIUM CUP AND MDM WAS REMOVED; SMITH & NEPHEW CAGE PUT IN WITH A STRYKER ALL-POLY CONSTRAINED CUP. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR WANTED TO ¿ROUGH UP¿ THE BACK OF THE ALL POLY CONSTRAINED CUP, I TOLD HIM THIS WAS OFF-LABEL. HE USED THE BONE NIBBLERS ON THE BACK OF THE CUP; WHERE THE CEMENT INTERFACE WAS. PATIENT IS FEMALE, OVER 70 YEARS OLD, OPERATIVE SIDE IS RIGHT HIP.

  Patient problems: Injury

  MAUDE report 10211344 ↗
• InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT PRESENTED WITH COMPLAINT OF PAIN (LOCATION AND SEVERITY OF PAIN UNKNOWN), SUBSEQUENT SCANS REVEALED THE PRESENCE OF PSEUDO TUMOR. INTRA-OPERATIVELY, NO BLACK TISSUE NOTED BUT THE PATIENT DID HAVE DISCOLORED FLUID. THE SHELL, MDM/ ADM LINER CONSTRUCT, AND BIOLOX CERAMIC HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER C-TAPER HEAD. THE STEM WAS NOT REVISED. THE EXPLANTS ARE AVAILABLE FOR RETURN.

  Patient problems: Edema; Injury; Pain

  MAUDE report 8803228 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: [SURGEON] REMOVED MDM LINER AND INSERT FROM PATIENT. REPLACED WITH A STRYKER TRIDENT X3 10° POLY INSERT". SPOKE TO REP. PATIENT WAS REVISED DUE TO SUSPECTED INFECTION AND SUSPECTED METALLOSIS (INFECTION AND METALLOSIS SUSPICIONS REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED/ IDENTIFIED). REP PROVIDED EXPLANT PICTURES SHOWING THE MDM/ ADM LINER CONSTRUCT AND COMPETITOR CERAMIC HEAD EXPLANTED (REP CONFIRMED THE HEAD WAS A COMPETITOR HEAD).

  Patient problems: Injury; Reaction; Unspecified Infection

  MAUDE report 8266820 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATION OF FEMORAL HEAD FROM MDM LINER INSERT.

  Patient problems: Injury

  MAUDE report 8175234 ↗