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RHEAD 310-2011Recalls & reported problems

Stryker GmbH · Stem Implant Plasma Coated, Size 2 · 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 00886385024028), received between Mar 21, 2019 and Mar 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Loose or Intermittent Connection1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryMar 21, 2019Loose or Intermittent Connection

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN OF THE LEFT RADIUS AFTER IMPLANTATION IN JANUARY 2017. A CT SCAN ON (B)(6)2019 SHOWED LOOSENING OF THE RADIAL HEAD. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. SURGEON HAS NOT YET REPORTED ANY PLAN TO REVISE THE PATIENT. PER THE OPERATIVE REPORT, AS PART OF THE CT SCAN, SOFT TISSUES APPEARED WITHIN NORMAL LIMITS AND THE REMAINING BONY STRUCTURES WERE UNREMARKABLE, THEREFORE NO SERIOUS INJURY OCCURRED.

    Patient problems: Pain

    MAUDE report 8441696 ↗

Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices

All PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices →

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