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PROFEMUR® PLSER012Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ12 V8DG SHORT NECK · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684PLSER0121), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 injury.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 27, 2022Appropriate Device Problem Term/Code Not Available

    ALLEGEDLY, FEMUR FRACTURE WAS REPAIRED WITH PLATE AND A NEW HEAD WAS IMPLANTED COMPONENTS NOT REVISED: PRODUCT ID: DSPCGD52; PRODUCT: DYNASTY® PC SHELL 52MM GROUP D LOT#:1653760. PRODUCT ID: DLXPGD36; PRODUCT: DYNASTY® A-CLASS® 36MM STD LOT#:1643153.

    Patient problems: Bone Fracture(s)

    MAUDE report 14218562 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.