Dynasty DLXPLG36Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684DLXPLG361), received between Nov 21, 2019 and Nov 14, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT DISLOCATED 1-2 WEEKS AFTER SURGERY THE SOFT TISSUES WERE VERY LAX REQUIRED ZIMMER CONSTRAINED.

  Patient problems: Joint Dislocation

  MAUDE report 15788740 ↗
• InjuryMay 12, 2021Naturally Worn; Naturally Worn

  ALLEGEDLY, PATIENT WAS IN KITCHEN AND FELT A "POP" AND THEN THE JOINT SQUEAKED. X-RAYS INDICATED A SUSPECTED CRACKED POLY LINER. DURING REVISION IT WAS SEEM THAT THE POLY WAS INTACT BUT THE PATIENT WAS IMPINGING AND WEARING THE RIM OF THE LINER AND CUP. PLEASE SEE ATTACHED PHOTOS. CUP WAS REVISED AND A BIOLOX DELTA OPTION HEAD WAS IMPLANTED. POSSIBLY PATIENT WAS EXTERNALLY ROTATING EXCESSIVELY LEADING TO IMPINGEMENT AND ECCENTRIC WEAR. PRODUCTS NOT REVISED: PROFEMUR PLASMA Z CLASSIC FEMORAL STEM W/LONG NECK SIZE 7 VARUS 8 DEGREE / PRODUCT ID: PHAPE244 / LOT NUMBER: 0798768751605863.

  Patient problems: Loss of Range of Motion

  MAUDE report 11812462 ↗
• InjuryJan 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO THE PATIENT DISLOCATING. ALL COMPONENTS REMOVED, REPLACED WITH DIFFERENT MANUFACTURERS SYSTEM, APART FROM THE 36MM MPO FEMORAL HEAD, WHICH WAS REMOVED AND REPLACED WITH A 28MM MPO FEMORAL HEAD. (B)(6).

  Patient problems: No Information

  MAUDE report 9577184 ↗
• InjuryNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR PULLED THE NECK, HEAD, SLEEVE, LINER, AND 3 SCREWS AND CEMENTED IN A BIOMET CONSTRAINED LINER. THE PATIENT HAD A PREVIOUS REVISION FOR MOM, INCIDENT GROUP (B)(6), A SECOND REVISION FOR INFECTION, INCIDENT GROUP (B)(6), AND A THIRD REVISION FOR DISLOCATION, INCIDENT GROUP (B)(6). ITEMS NOT REVISED: DYNASTY BIOFOAM SHELL DSBFGG60 LOT 079859623. PROFEMUR PLASMA Z STEM PHA00270 LOT 067445032.

  Patient problems: No Information

  MAUDE report 9357241 ↗