Dynasty DLXPGE38Recalls & reported problems
Microport Orthopedics Inc. · DYNASTY® A-CLASS® 38MM STD GROUP E CROSSLINKED POLY LINER · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684DLXPGE381), received between Jul 22, 2020 and Nov 1, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component5
- Insufficient Device Problem Information2
- Break1
Patient problems
- Insufficient Information3
- No Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ALLEGEDLY, DURING REVISION OF A PATIENT WITH A THA REPLACEMENT IN 2011, A LINER AND NECK FRACTURE WERE IDENTIFIED. THE NECK WAS CONFIRMED ON PREOPERATIVE CT AND THE LINER WAS FOUND TO HAVE BEEN DAMAGED INTRAOPERATIVELY. THE LINER WAS DAMAGED BECAUSE IT PROTRUDED FROM THE CUP. AS FOR THE NECK, IT IS NECESSARY TO INVESTIGATE THE POSSIBILITY OF INTERNAL DAMAGE. JAPAN (B)(4).
Patient problems: Insufficient Information
MAUDE report 20587971 ↗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 17739196 ↗InjuryJan 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, COMPONENTS REVISED FOR UNKNOWN REASONS. HIGH BMI.
Patient problems: Insufficient Information
MAUDE report 13397167 ↗InjuryJul 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DO TO UNKNOWN REASONS, AFTER A LEFT HIP ARTHROPLASTY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12175744 ↗InjuryJul 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, PATIENT WAS REVISED FOR LINER DISSOCIATION. TIME TO REVISION WAS 63 MONTHS ADDITIONAL INFORMATION: INDICATION FOR SURGERY WAS POLYETHYLENE FAILURE. BMI WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 10319640 ↗InjuryJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, PATIENT WAS REVISED FOR LINER DISSOCIATION. TIME TO REVISION WAS 29 MONTHS COMPONENT NOT REVISED: DYNASTY(R) SHELL PRODUCT ID: DXXXGF56 LOT ID: NOT INDICATED. ADDITIONAL INFORMATION: INDICATION FOR SURGERY WAS AVASCULAR NECROSIS. BMI: 28.
Patient problems: No Code Available
MAUDE report 10311809 ↗InjuryJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, PATIENT WAS REVISED FOR LINER DISSOCIATION. TIME TO REVISION WAS 160 MONTHS. COMPONENTS NOT REVISED: BCH(R) TOTAL FEMORAL HEAD PRODUCT ID : 38CH3800 LOT ID: NOT INDICATED. PROFEMUR(R) COCR NECK PRODUCT ID : PHAC12XX LOT ID: NOT INDICATED. ADDITIONAL INFORMATION INDICATION FOR SURGERY WAS OSTEOARTHRITIS. BMI: 23.
Patient problems: No Information
MAUDE report 10307223 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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