Dynasty DLXPGG36Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684DLXPGG361), received between Mar 24, 2020 and Feb 2, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 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.

• InjuryFeb 2, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, THE PATIENT EXPERIENCED DISLOCATION, LOSS OF MOBILITY, SWELLING, ADVERSE TISSUE REACTION, AND PAIN DUE TO METAL ON-METAL COMPONENTS. ADDITIONAL INFORMATION RECEIVED ON 2023-02-09: (B)(6) 2021 LEFT SOFT TISSUE MASS THAT HAS DEVELOPED AFTER HAVING HIS LEFT HIP REPLACED. IT DOES NOT CAUSE PAIN TO THE PT. 2021-04-28 PT. BROKE HIS HIP SPONTANEOUSLY WHILE WALKING, HE FELT PAIN - FELL OFF THE TRUCK AT WORK A WEEK EARLIER - THE PLASTIC PIECE FROM HIS THR HAS BROKEN AND CAN HEAR IT (CREAKING/ QUAKING) WHEN HE WALKS (DISCOMFORT TO WALK). X-RAYS SHOW POSSIBLE POLYETHYLENE WEAR, THE HARDWARE ITSELF REMAINS INTACT. NO PERIPROSTHETIC FRACTURE IS IDENTIFIED. 2021-05-11 NO SIGNIFICANT OSTEOLYSIS IS IDENTIFIED. THE POSITION OF THE ACETABULAR COMPONENT RAISE THE POSSIBILITY OF LOOSENING. 2021-07-12 LEFT TOTAL HIP ARTHROPLASTY, I AND D, AND HEAD AND LINER, CANCELLED PT. FEELING UNWELL. 2021-09-02 THA REVISION SURGERY. (B)(6) 2021 LEFT HIP PERIPROSTHETIC INFECTION, PAIN. IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGE

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 16283116 ↗
• InjuryJun 20, 2022Unstable; Unstable

  ALLEGEDLY, REVISED FOR INSTABILITY TO LARGER HEAD. THE FOLLOWING PRODUCTS WERE NOT REVISED: PRODUCT ID: DBFPGG62 DYNASTY BIOFOAM SHELL 62MM, LOT: 1700901, QTY: 1. PRODUCT ID: 18080302 CANCELLOUS SELF-TAPPING BONE SCREW 6.5X2.5, LOT: 1805477, QTY: 1. PRODUCT ID: PRTLEL30 PROFEMUR TL CLASSIC 10 VARUS LONG NECK, LOT: 1873812, QTY: 1.

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

  MAUDE report 14748875 ↗
• InjuryMar 24, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT REVISED FOR INSTABILITY WITH A DUAL MOBILITY CUP. COMPONENT NOT REVISED: PROFEMUR RENAISSANCE STEM LONG PRODUCT ID: PLLES013 LOT NO.: 1617782.

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

  MAUDE report 11562242 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , PATIENT REVISED DUE TO UNKNOWN FAILURE.

  Patient problems: No Information

  MAUDE report 9874089 ↗