Dynasty DBFPGE54Recalls & reported problems
Microport Orthopedics Inc. · DYNASTY® BF SHELL PRIMARY 54MM GROUP E · Class 2 · Implant
All models of Dynasty (44)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684DBFPGE541), received between Sep 13, 2023 and Apr 13, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Loss of Osseointegration1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Loss of Osseointegration
ALLEGEDLY, LINER AND HEAD REVISED. STEM AND CUP RETAINED. CUP WAS VERTICAL. JOINT WAS NOT TIGHT AND HEAD WAS RIDING ON POLY SUPERIOR EDGE CAUSING POLY TO FRACTURE. LINER WAS NOT DISASSOCIATED. XRAYS TO BE PROVIDED. REVISED TO DUAL MOBILITY, ADDING 9-10MM OF LENGTH TO STABILIZE AND TIGHTEN JOINT. NON REVISED RELATED MPO PRODUCTS: PROFEMUR® PRESERVE CLASSIC /PRODUCT ID: PPRCLS06 /LOT. NO: 1787281 /QTY: 1. ADDITIONAL INFORMATION RECEIVED ON 03/18/2026 BY RELIABILITY ENGINEERING CONFIRMING CUP LOOSENING. THIS COMPONENT WAS NOT REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865139 ↗InjurySep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, DISSOCIATION OF POLY LINER FROM SHELL. REVISION PROCEDURE ENTAILED REMOVAL OF FEMORAL HEAD, HEAD SLEEVE, DISSOCIATED POLY LINER, WELL AFFIXED SHELL AND APICAL HOLE PLUG. ANOTHER COMPANIES SHELL, LINER AND DUAL MOBILITY HEAD WERE THEN IMPLANTED IN CONJUNCTION WITH MPO 28MM MEDIUM CERAMIC HEAD.
Patient problems: Insufficient Information
MAUDE report 17739627 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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