Dynasty DSPCGB48Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684DSPCGB481), received between Mar 11, 2020 and Mar 29, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, QS DIRECTOR RECEIVED A CALL FROM A PATIENT, FOR SOME REASON PATIENT HAS BEEN EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 16637374 ↗
• InjuryNov 22, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY PT UNDERWENT PRIMARY THR SURGERY ON (B)(6) 2020, REVISED ON (B)(6) 2021 DUE TO LOOSENING OF THE ACETABULAR COMPONENT. CUP SHIFTED POSITION WITHOUT ANY BONE IN GROWTH, SAT IN SLIGHTLY AFTER SURGERY AS MAY NOT HAVE BEEN FULLY SEATED AND THEN MOVED POSITION MORE RECENTLY. MPO HEAD, LINER, SCREWS AND SHELL REMOVED. FEMORAL HEAD REPLACED WITH MPO PHA04418. OTHER COMPONENTS REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12851898 ↗
• InjuryApr 19, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT COMPLAINED OF PAIN. X-RAY INDICATED ACETABULAR CUP LOOSENING. CUP WAS REVISED TO DUAL-MOBILIY CUP. Z STEM WAS LEFT AND BIOLOX DELTA OPTION HEAD WAS IMPLANTED. COMPONENT NOT REVISED: PROFEMUR® PLASMA Z CLASSIC SIZE 3 VARUS 8 DG SHORT NECK PRODUCT ID: PHAPCLE3. LOT: 1633611.

  Patient problems: Pain

  MAUDE report 11686242 ↗
• 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. (B)(4).

  Patient problems: No Information

  MAUDE report 9821750 ↗