simply Legacy™3 Implant 853216URecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841307107736), received between Oct 21, 2020 and Mar 26, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K192221); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Loss of Osseointegration

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 24707145 ↗
• InjuryDec 1, 2025Malposition of Device; Malposition of Device

  LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680703 ↗
• InjuryDec 1, 2025Failure to Osseointegrate; Failure to Osseointegrate

  LACK OF PRIMARY STABILITY.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680560 ↗
• InjuryMar 6, 2025Premature Separation; Premature Separation

  PART NOT RETAINED ON MATING PART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541152 ↗
• InjuryDec 18, 2020Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain; Unspecified Infection

  MAUDE report 11034516 ↗
• InjuryOct 21, 2020Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 10709673 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.

• Z-0197-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
• Z-0198-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,