Infinity AIM KMR2RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20845854649890), received between Oct 19, 2022 and Jun 6, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KMR2R, INFINITY AIM MENISCAL REPAIR DEVICE, 15° REVERSE, WAS BEING USED DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿UPON USING ONE OF OUR INFINITY AIM MENISCAL REPAIR DEVICES (FIRST DEVICE TO BE USED), THE SECOND IMPLANT BASICALLY FELL OUT OF THE SHEATH OF THE DEVICE AS THE SURGEON PULLED THE DEVICE BACK TO IMPLANT IT. HE DID NOT PULL THE DEVICE AWAY FROM THE MENISCUS IN ANY EXCESSIVE MANNER. IT JUST SEEMED AS THOUGH THE ANCHOR FELL OUT. WE USED ANOTHER FIVE MORE DEVICES TO REPAIR THE DAMAGED MENISCUS AND THESE WENT WITHOUT INCIDENT. HE HAD TO THEN CUT OUT THE PEEK ANCHOR FROM THE INSIDE PORTION OF THE MENISCUS. THIS ONLY TOOK A MINUTE OR TWO TO COMPLETE.¿ AN ALTERNATE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE CAUSING A 1 TO 2-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157339 ↗
• InjuryOct 19, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE, KMR2R, INFINITY AIM MENISCAL REPAIR DEVICE, 15 DEG. REVERSE WAS BEING USED ON (B)(6) 2022 DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH MENISCAL REPAIR & POSTEROLATERAL REPAIR WHEN IT WAS REPORTED ¿2ND CLEAT BROKE DURING TENSIONING.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿PEAK CLEATS WERE NOT RETRIEVED FROM SURGICAL SITE, BEHIND CAPSULE.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF DOUBLE ENDED SUTURES AND A ONE-HOUR DELAY WAS REPORTED DURING THE PROCEDURE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS ¿RECOVERING¿. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT RETAINING FRAGMENTATION OF THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15633801 ↗