PROMOS 75006539Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996037593), received between Jan 20, 2022 and Jan 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K081016); 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 16, 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.

• InjuryJan 20, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A PROMOS REVERSE SHOULDER ARTHROPLASTY, X-RAYS SHOWED THAT THE PROMOS HUMERAL STEM 3 NON-CEM SHEARED OFF. ON (B)(6) 2022 A REVISION SURGERY WAS PERFORMED. THE CURRENT HEATH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13310759 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081016. One submission often covers many models, so check the product and lot details in each record.

• Z-0960-2009 · Nov 21, 2008 · Terminated
  PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer
• Z-0961-2009 · Nov 21, 2008 · Terminated
  PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cemen