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Exeter 6309-3-260Recalls & reported problems

Howmedica Osteonics Corp. · RimFit Cup · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327072273), received between Oct 3, 2017 and Oct 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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

  • Difficult to Open or Remove Packaging Material1
  • Material Distortion1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 3, 2017Difficult to Open or Remove Packaging Material; Material Distortion; Difficult to Open or Remove Packaging Material; Material Distortion

    THE HOSPITAL COULD NOT OPEN THE PACKAGE IN A STERILE WAY. THE PAPER THAT YOU TEAR AWAY TO OPEN THE PACKAGE WAS STUCK IN THE PLASTIC THAT SURROUNDS THE IMPLANT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6909701 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

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