HTR-PEKK PK620898Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810042034037), received between Jul 19, 2018 and Mar 26, 2019 — classified as 2 injuries.

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 18, 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.

• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem

  THE SALES REP RECEIVED INFORMATION FROM THE PHYSICIAN THAT SHE PLANS TO REMOVE THE IMPLANT, AS IT WAS INFECTED AGAIN. UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION APPROXIMATELY ONE-WEEK POST OP. AT THAT TIME, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION WAS THOUGHT TO HAVE BEEN RESOLVED. THE SALES REP WAS UNABLE TO CONFIRM WHETHER THIS IS A DIFFERENT TYPE OF INFECTION OR WHEN IT WAS IDENTIFIED. THIS REPORT IS 1 OF 2 AS TWO SEPARATE DEVICES WERE IMPLANTED AT THE SAME TIME.

  Patient problems: Unspecified Infection

  MAUDE report 8452606 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem

  THE SALES REP REPORTED THAT THERE WAS AN INFECTION APPROXIMATELY 1 WEEK POST-OP. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION HAS RESOLVED. THERE IS NO REVISION PLANNED. NO STERILIZATION RECORDS ARE AVAILABLE. THERE IS NO KNOWN HISTORY OF INFECTION AT THE FACILITY. THIS IS REPORT 1 OF 2 AS TWO SEPARATE DEVICES WERE IMPLANTED AT THE SAME TIME.

  Patient problems: Unspecified Infection

  MAUDE report 7704859 ↗