PowerPro PRO2047Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854028438), received between Aug 15, 2024 and Aug 15, 2024 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO2047, POWERPRO ZIMMER/HUDSON REAMER ATTACHMENT DEVICE WAS BEING USED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024, AND ¿IT WAS REPORTED THAT THIS PRODUCT BROKE INTO TWO PIECES DURING USE¿. FOLLOW-UP ASSESSMENT FOUND THAT A PIECE OF THE DEVICE FELL INTO THE SURGICAL SITE AND A FORCEPS-LIKE INSTRUMENT WAS USED TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH ¿BACKUP INSTRUMENTS¿ AND WITH NO DELAY. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990320 ↗