MDM 626-00-36CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540665997), received between Aug 29, 2019 and May 27, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: POSTOPERATIVE PHOTOGRAPHS REVEALED THAT THE MDM LINER HAD NOT BEEN POSITIONED CORRECTLY, SO THE WOUND WAS REOPENED AND THE LINER REPOSITIONED.

  Patient problems: Insufficient Information

  MAUDE report 25299616 ↗
• InjuryMar 3, 2025Degraded; Patient-Device Incompatibility; Degraded; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED: AROUND AUTUMN 2024, THE PATIENT WAS FOUND TO HAVE A METAL (COBALT CHROME) ALLERGY, AND THERE WAS A POSSIBILITY THAT THE REVISION WOULD BE PERFORMED AGAIN. AFTER THAT, THE PATIENT REQUESTED THAT THE SURGERY BE PERFORMED. REVISION THA WAS PERFORMED ON THE PATIENT. ALTHOUGH THERE WAS NO LOOSENING OR MALPOSITIONING OF THE IMPLANTS OR ANY NOTICEABLE DAMAGE, DAMAGE TO THE SOFT TISSUE (PARTICULARLY THE GLUTEUS MEDIUS MUSCLE) WAS OBSERVED. WHEN THE IMPLANTS WERE REMOVED, WHITE TISSUE WAS FOUND TO BE STUCK TO THE INNER SURFACE OF THE CUP (BETWEEN THE TRIDENT II-MDM LINER). REQUEST FROM THE DOCTOR: ALTHOUGH IT IS THOUGHT THAT THIS PHENOMENON MAY BE DUE TO AN ALLERGIC REACTION OF THE PATIENT TO THE CO-CR ALLOY IMPLANT, THE DOCTOR BELIEVES THAT THERE MAY BE OTHER FACTORS INVOLVED, AS THE SOFT TISSUE DAMAGE WAS SEVERE AND THERE WAS A LOT OF TISSUE ADHESION BETWEEN THE CUP AND LINER. THE DOCTOR HAS REQUESTED THAT STRYKER INVESTIGATE THE EXTENT AND CAUSE OF DAMAGE AND WEAR OF THE DEVICES THAT WAS REMOVED ON (B)(6).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 21511250 ↗
• InjurySep 10, 2024Degraded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HER BLOOD. ADDITIONAL INFORMATION PER MEDICAL RECORDS RECEIVED: "EXPOSED SOME BURSAL TISSUE AND METALLIC FLUID ON THE SUPEROLATERAL ASPECT OF THE GREATER TROCHANTER, TRACKED DOWN INTO THE JOINT SPACE. I NOTICED A LARGE DEFECT IN THE SUPERIOR LATERAL ASPECT OF THE BASE OF THE NECK OF THE IMPLANT, INDICATING IMPINGEMENT." UPDATE PER MEDICAL REVIEW: THE CUP WAS NOTED AND THE PATIENT WAS DIAGNOSED WITH A LOOSE ACETABULAR COMPONENT. FINDINGS AT SURGERY INCLUDED RIGHT HIP EXTENSIVE METALLOSIS WITHIN THE JOINT SPACE THE FEMORAL COMPONENT WAS WELL FIXED THE ACETABULAR COMPONENT WAS GROSSLY LOOSE THE MDM METAL INSERT IMPINGED AGAINST THE STEM OF THE FEMUR AND HAD WORN AWAY APPROXIMATELY 20 TO 25% OF THE BASE OF THE NECK OF THE IMPLANT ON THE IT'S POSTERIOR SUPERIOR ASPECT.

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

  MAUDE report 20186385 ↗
• InjuryMar 23, 2021Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED A REVISION SURGERY ON (B)(6) 2021. HE REMOVED A COCR MDM LINER FROM A TRIDENT II CUP THAT HAD BEEN IN 15 MONTHS. THE PT. COMPLAINED OF PAIN AND EFFUSION. UPDATE 26/FEBRUARY/2021 (B)(6): SPOKE TO REP. PATIENT ALSO HAD ELEVATED ION LEVELS. THE MDM METAL LINER, ADM/ MDM INSERT, AND CERAMIC HEAD WERE REVISED. REP REPORTED HE MAY BE ABLE TO CONFIRM THE OPERATIVE SIDE (AS THIS PATIENT HAS AN IDENTICAL, AS-YET-NOT-REVISED CONSTRUCT IN HIS OTHER HIP), AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11556032 ↗
• InjuryAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MDM METAL LINER AND TRIDENT PSL SLIP OFF . IT WAS TREATED BY REVISION SURGERY. TO REVISION. UPDATE: " THE MDM METAL LINER COME OUT OF THE PSL SHELL".

  Patient problems: Injury

  MAUDE report 8944175 ↗