Dynasty DSBFGE54Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684DSBFGE541), received between Jan 6, 2020 and Dec 2, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT HAD A MOD Z STEM & NECK, DYNASTY METAL ON METAL ACETABULUM. SURGEON WANTED TO REMOVE THE METAL ON METAL (MOM) INCLUDING THE STEM. HE RETAINED THE DYNASTY SHELL. INSERTED A DUAL MOBILITY LINER AND INSERT. HE REPLACED THE STEM WITH A ZIMMER REVISION STEM AND 28MM CERAMIC HEAD.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 23697522 ↗
• InjuryDec 14, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  ALLEGEDLY, REVISION DUE TO LINER DISASSOCIATION. SURGEON SUSPECTS PROBLEM WITH CUP. PRODUCT NOT REVISED: PRGLCLE4 PROFEMUR® GLADIATOR® CLASSIC PLASMA SIZE 4 VARUS 8 DG NECK, LOT: 1787126, QTY: 1.

  Patient problems: Loss of Range of Motion

  MAUDE report 18325970 ↗
• InjuryJan 10, 2023Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT R THR ON (B)(6) 2015. REVISED ON (B)(6) 2022 AS CUP MOVED. SURGEON HAD SEEN PATIENT POST OP AND FOLLOW UPS WITH GOOD RESULTS, SURGEON BELIEVES THE MOVEMENT TOOK PLACE RECENTLY. HEAD REVISED WITH A BIOLOX DELTA, THE CUP WAS REVISED WITH ANOTHER MANUFACTURER'S COMPONENT. (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16133562 ↗
• InjuryAug 29, 2021Loss of Osseointegration; Loss of Osseointegration

  (B)(4). ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN AND LOOSENING. TROCHANTERIC NON-UNION DUE TO INADEQUATE REATTACHMENT AND OR EARLY WEIGHT BEARING. HE HAS HAD LACK OF INGROWTH OF THE ACETABULAR COMPONENT. OPERATIVE SIDE: RIGHT. THE DYNASTY BIOFAM SHELL, DYNASTY A-CLASS POLYLINER, AND SCREWS WERE REVISED. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR® NECK A/R 8DG SHORT COBALT CHROME CATALOG NUMBER: PHAC1232 LOT NUMBER: 1407107. PRODUCT NAME: PROFEMUR® GLADIATOR® CEMENTED STEM SZ 4 CATALOG NUMBER: RGLCM04 LOT NUMBER: 1453286. PRODUCT NAME: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 36MM CATALOG NUMBER: 38AM3604 LOT NUMBER: 1452346.

  Patient problems: Pain

  MAUDE report 12381671 ↗
• InjuryApr 8, 2020Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  ALLEGEDLY THE PATIENT UNDERWENT RIGHT THR ON (B)(6) 2019, REVISED ON (B)(6) 2019 DUE TO CUP MAL-POSITIONING. THE PATIENT DISLOCATED THREE TIMES FOLLOWING PRIMARY SURGERY. DURING REVISION THE SAME CUP WAS REPOSITIONED, FLAT LINER REPLACED WITH HOODED LINER, LONGER HEAD WAS USED AND A SCREW ADDED. BOTH PROCEDURES WERE PERFORMED THROUGH POSTERIOR APPROACH.

  Patient problems: No Information

  MAUDE report 9940921 ↗
• InjuryFeb 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ELEVATED COBALT ION LEVELS, PAIN AND STIFFENS OF THE HIP. IT WAS DISCOVERED THAT THE DEVICE FAILED DUE TO CORROSION OF THE OBLONG TAPER OF MODULAR NECK WHERE IT SEATED IN THE POCKED OF THE TITANIUM STEM.

  Patient problems: Pain

  MAUDE report 9717147 ↗
• InjuryJan 6, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY PATIENT WAS REVISED FOR ASEPTIC LOOSENING AND METALLOSIS WAS DISCOVERED INTRAOPERATIVE. RIGHT HIP.

  Patient problems: No Information

  MAUDE report 9554261 ↗