HMRS 6465-6-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327048933), received between Mar 20, 2018 and Jun 13, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2022Degraded; Fracture; Unstable; Naturally Worn; Degraded; Fracture; Unstable; Naturally Worn

  REVISION (HMRS PARTS REPLACEMENT AFTER 12 YEARS) ACCORDING TO BFARM SPECIAL APPROVAL 92.16-5640-S-023/22. 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 14674068 ↗
• InjuryApr 11, 2022Degraded; Unstable; Naturally Worn; Degraded; Unstable; Naturally Worn

  THE FOLLOWING WAS REPORTED: REVISION (HMRS PARTS REPLACEMENT). AFTER 23 YEARS, THE POLY IS WORN OUT. IT IS MANIFESTED BY HYPEREXTENSION OF THE KNEE JOINT AND MARKED INSTABILITY. THE DISTAL FEMUR SHOWS SIGNS OF WEAR, WHICH SHOWS UP AS METALLOSIS IN THE KNEE JOINT. "NOW AFTER THE REVISION SURGERY EVERYTHING WAS FINE AGAIN."

  Patient problems: Ambulation or Postural Difficulties; Hyperextension; Joint Laxity

  MAUDE report 14073862 ↗
• 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 13767231 ↗
• MalfunctionMar 20, 2018Difficult to Insert; Difficult to Insert

  DURING GROWING KOTZ SURGERY, HMRS WEDGE COULD NOT BE INSERTED. THE WEDGE WAS EXCHANGED WITH ANOTHER NEW ONE AND THE SURGERY WAS COMPLETED WITH IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7354145 ↗