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HMRS 6466-9-230Recalls & reported problems

Howmedica Osteonics Corp. · G I-II. CIRCLIPS · Class 2 · Implant

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

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540276520), received between Oct 7, 2019 and Jun 15, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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

  • Component Incompatible1
  • Degraded1
  • Inadequacy of Device Shape and/or Size1
  • Naturally Worn1
  • Unstable1

Patient problems

  • Insufficient Information1
  • Joint Laxity1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 15, 2022Unstable; Unstable

    REVISION (HMRS PARTS REPLACEMENT AFTER 12 YEARS) ACCORDING TO BFARM SPECIAL APPROVAL. UPDATE 25MAY22, AFTER 12 YEARS , THE POLY IS WORN OUT. THERE WAS A MASSIVE INSTABILITY IN THE KNEE JOINT. ESPECIALLY THE STOPPER ON THE PROXIMAL TIBIA WAS VERY CRUSHED.

    Patient problems: Joint Laxity

    MAUDE report 14691910 ↗
  • InjuryMar 15, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

    HMRS PARTS REPLACEMENT AFTER 12 YEARS. THE WEAR OF THE COMPONENTS WAS CONFIRMED DURING THE SURGERY. THE PARTS HAVE ALL BEEN REPLACED AS REQUESTED. SOME POLY PARTS WERE SEVERELY DAMAGED OR DISASSEMBLED INTO INDIVIDUAL PARTS DUE TO THE DIFFICULT DISASSEMBLY. DUE TO WEAR AND TEAR, IT WAS SUSPECTED THAT REPLACING THE COMPONENTS WOULD BE PRUDENT.

    Patient problems: Insufficient Information

    MAUDE report 13769223 ↗
  • MalfunctionOct 7, 2019Component Incompatible; Inadequacy of Device Shape and/or Size; Component Incompatible; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT THE CIRCLIP USED TO LOCK THE AXLE IN PLACE WAS TOO SMALL TO PROPERLY LOCK THE AXLE. UPDATE: 5 MINUTES SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9162681 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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