DHHS 282.611Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982178688), received between Jun 6, 2017 and Jun 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017. WHEN THE SURGEON ATTEMPTED TO SEAT THE BARREL OVER THE BLADE WITH THE IMPACTOR, THE BLADE ADVANCED THROUGH THE PATIENT'S FEMORAL HEAD AND BECAME STUCK INSIDE THE DYNAMIC HELICAL HIP SYSTEM (DHHS) BARREL. THERE WAS A DELAY OF 30 TO 45 MINUTES TO COMPLETE THE SURGERY. THE SURGEON ATTACHED THE THREADED EXTRACTOR FROM THE DHHS SET AND USED A SLOTTED HAMMER TO REMOVE THE BLADE. SINCE IT WAS STUCK, THE BLADE AND BARREL HAD TO COME OUT AS A UNIT. ANOTHER BLADE WITH THE SAME PART NUMBER WAS USED TO COMPLETE THE REST OF THE SURGERY SUCCESSFULLY AND WITHOUT FURTHER ISSUES. THE PATIENT'S STATUS WAS STABLE. NO ADDITIONAL INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: IMPACTOR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 3 HOLES. (B)(4).

  Patient problems: No Code Available

  MAUDE report 6615691 ↗