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Duracon 6642-9-616Recalls & reported problems

Howmedica Osteonics Corp. · Constrained Tibial Insert · Class 2 · Implant

All models of Duracon (58)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 04546540319371), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Device problems

  • Device-Device Incompatibility1
  • Labelling, Instructions for Use or Training Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 13, 2018Labelling, Instructions for Use or Training Problem; Device-Device Incompatibility; Labelling, Instructions for Use or Training Problem; Device-Device Incompatibility

    I WAS NOTIFIED ON MONDAY THE (B)(6) BY ONE OF OUR LOCAL DOCTORS THAT HE NEEDED DURACON CR INSERTS AVAILABLE FOR A POLY SWAP ON THE (B)(6). DUE TO THE AVAILABILITY WE ONLY RECEIVED DURACON "CONSTRAINED" INSERT IMPLANTS. ONCE I WAS FOR CERTAIN THE AP LIPPED WEREN'T AVAILABLE, I THEN CONTACTED A MARKETING MANAGER AT CORPORATE TO INQUIRE ABOUT WHAT THE "CONSTRAINED" OPTION MEANT. SHE PROCEEDED TO TELL ME THIS WAS A DEEP DISH POLY VERSUS THE AP LIPPED. AS WE PROCEEDED WITH THE CASE, HE REMOVED THE OLD POLY, AND WE TRIALED WITH A CONDYLAR TRIAL AND ASKED ME TO OPEN THE SMALL 13MM IMPLANT (6642-9-613). THE DOCTOR WAS UNABLE TO MAKE IT SIT DOWN AND UNFORTUNATELY THE INSERT HIT THE FLOOR. WE THEN PROCEEDED TO THE 16MM INSERT (6642-9-616). THE DOCTOR AGAIN WAS HAVING PROBLEMS WITH IT LOCKING INTO THE BASEPLATE. WE INSPECTED THE POLY AND REALIZED THIS PARTICULAR IMPLANT WAS DESIGNED FOR A PCA BASEPLATE. DUE TO THE FACT THE BOX SIMPLY READ DURACON AS WELL THE INFORMATION MARKETING GAVE ME I WAS UNABLE TO PREVENT THIS OCCURRENCE. UPDATE: REP REPORTED THAT THE FIRST DEVICE "POPPED OUT" OF PATIENT AND HIT THE FLOOR OF THE OPERATING ROOM A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES WAS REPORTED OV

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7598185 ↗

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Sources and updates

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