Dynasty DLXPLE38Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684DLXPLE381), received between Feb 17, 2020 and Dec 14, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• 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 18325883 ↗
• InjuryDec 11, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  ALLEGEDLY, REVISION DUE TO LINER DISASSOCIATION, WEAR, AND POSSIBLE IMPINGEMENT. PRODUCTS NOT REVISED: PRGLCLE4 PROFEMUR® GLADIATOR® CLASSIC PLASMA SIZE 4 VARUS 8 DG NECK, LOT: 1787126, QTY: 1 DSBFGE54 DYNASTY® BF SHELL 54MM GROUP E, LOT: 1787915, QTY: 1.

  Patient problems: Loss of Range of Motion

  MAUDE report 18303104 ↗
• InjuryMay 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATED LINER. COMPONENTS NOT REVISED: PROFEMUR® RENAISSANCE® STEM REDUCED SZ 14, PRODUCT ID: PLS0R414, LOT ID: 1750310, CONSERVE® TOTAL MEDIUM NECK SLEEVE, PRODUCT ID: 38NS0000, LOT ID: 1723377, PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME, PRODUCT ID: PHAC1252, LOT ID: 1736349.

  Patient problems: No Information

  MAUDE report 10027022 ↗
• 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: Loss of Range of Motion; Pain

  MAUDE report 9717101 ↗