MDM 626-00-52HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540666048), received between Nov 11, 2019 and Jul 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Unstable; Unstable

  AS REPORTED: "REVISION OF LEFT TOTAL HIP DONE TODAY. THIS PATIENT PRESENTED WITH A PERIPROSTHETIC FRACTURE OF HIS RIGHT HIP WHICH WAS COMPETITOR TOTAL HIP. ORIGINALLY THE LEFT HIP WAS NOT A PROBLEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2025 TO ADDRESS THE FRACTURE USING COMPETITOR PRODUCTS. AFTER THAT SURGERY IT WAS DISCOVERED THAT THE LEFT HIP HAD DISLOCATED. THE LEFT HIP WAS REDUCED AND TRANSFERRED FROM TRAUMA SERVICE TO JOINT REPLACEMENT SERVICE. IT WAS DISCOVERED THAT THE 28MM HEAD HAD DISASSOCIATED FROM THE MDM POLY LINER. IT IS THOUGHT THAT THIS DISASSOCIATION OCCURS WHEN THE HIP WAS REDUCED. THE REVISION TODAY WAS TO ADDRESS THE INSTABILITY OF THE LEFT HIP. MDM IMPLANTS WERE REMOVED AND A CONSTRAINED LINER WAS PLACED. IT WAS ALSO DECIDED TO GO FROM A +4 NECK LENGTH TO A +8 TO ADDRESS LIMB LENGTH DISCREPANCY. NO FURTHER INFORMATION AVAILABLE FROM SURGEON OR HOSPITAL." REP CONFIRMED THAT INTRA-OPERATIVELY, THE POLY WAS FOUND FLOATING IN THE JOINT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22638120 ↗
• InjuryMay 9, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  THIS REPORT IS FOR THE (B)(6) 2022 REVISION. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2022 THE, REP CONFIRMED THAT ON (B)(6) 2022 THE HIP HAD BEEN REVISED AS WELL. AN MDM METAL LINER, ADM/ MDM POLY INSERT, FEMORAL HEAD, AND RESTORATION MODULAR PROXIMAL BODY WERE REVISED TO ANOTHER PROXIMAL BODY AND HEAD, AND A CONSTRAINED INSERT. UPDATE REASON FOR REVISION: "LEG LENGTH INEQUALITY AND INSTABILITY WITH HISTORY OF DISLOCATION. MDM HEAD DISLOCATION OUT OF MDM LINER."

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Unequal Limb Length

  MAUDE report 14342959 ↗
• InjuryNov 11, 2019Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2016: RAS IMPLANTED. COMPLEX REVISION FOR PELVIC DISCONTINUITY. PATIENT HAD 4 REVISIONS PRIOR TO THIS, HISTORY OF RA. ON (B)(6) 2018: PATIENT SEEN IN CLINIC AND REPORTED THAT SHE FELT HIP SHIFT AND DISLOCATE. LOOSENING OF ACETABULAR CUP IDENTIFIED ON X-RAY. RADIOLOGY REPORT: SLIGHT DISTRACTION OF THE ACETABULAR SCREWS IN COMPARISON TO THE PREVIOUS EXAMINATION THAT WOULD BE CONSISTENT. ON (B)(6) 2019: REMOVAL OF ACETABULUM IMPLANT AND FEMORAL HEAD EXCHANGE TO BIPOLAR IMPLANT. PATIENT FACTORS: SEDENTARY, WHEELCHAIR BOUND, HISTORY OF RECURRENT DISLOCATION. COMPETITOR STEM AND HEAD NOTED IN PER PRODUCT GRID.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9307403 ↗