Bio-Modular® Shoulder System 113921Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868253829), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 other recall cover devices cleared under the same FDA submission (K030710, K992899); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryDec 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A TEAR OF THE ROTATOR CUFF. FURTHER, THE PATIENT HAD LOOSENING OF THE GLENOID COMPONENT AND DISLOCATION OF THE POLYETHYLENE FROM THE POST IMPLANT.

  Patient problems: Failure of Implant; Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 15914640 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030710, K992899. One submission often covers many models, so check the product and lot details in each record.

• Z-0474-2013 · Nov 1, 2012 · Terminated
  Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindric