System 12 6302-5-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540269768), received between Nov 15, 2019 and Nov 21, 2022 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO MINOR INSTABILITY AND PAIN. A 28 +4 METAL HEAD AND SYSTEM 12 LINER WERE REVISED TO A 32MM BIOLOX HEAD WITH +4 SLEEVE AND A SYSTEM 12 10° LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15840846 ↗
• InjuryNov 15, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO MULTIPLE DISLOCATIONS AND SUSPECTED LINER WEAR. THE PATIENT'S HEAD AND LINER WERE REVISED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9329153 ↗