NA 282.237Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982178220), received between Nov 16, 2017 and Nov 17, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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.

• InjuryNov 17, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION SURGERY IS OCCURRED (B)(6) 2017 DUE TO A HELICAL BLADE CUT OUT. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2017 DUE TO AN EMERGENCY TRAUMA WHERE DYNAMIC HELICAL HIP SYSTEM (DHHS) DEVICES WERE IMPLANTED. CONSULTANT STATED THE FEMUR HEAD WAS SPLIT INTO TWO PARTS. THE SURGEON BELIEVES IT WAS PART OF THE ORIGINAL FRACTURE DUE TO THE ACCIDENT. NO SURGICAL DELAY WAS REPORTED. PATIENT WAS REVISED TO A TOTAL HIP IMPLANT. PATIENT STATUS WAS LISTED AS "OK" OR STABLE. PROCEDURE COMPLETED SUCCESSFULLY. INTRAOPERATIVE EVENTS DURING THE INITIAL PROCEDURE ON (B)(6) 2017 ARE ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE REVISION PROCEDURE. CONCOMITANT DEVICES REPORTED: 135 DEGREE LCP DHHS SIDEPLATE-STANDARD BARREL 4 HOLES (282.612, LOT 7832545, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HELIX BLADE 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7041338 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ARRIVED TO THE EMERGENCY OPERATING ROOM ON (B)(6) 2017 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL FEMUR. THE SURGEON INSERTED DYNAMIC HELICAL HIP SYSTEM (DHHS) IMPLANTS AND ON X-RAY DISCOVERED THE BLADE WAS IN WRONG POSITION. THIS WAS DISCOVERED BEFORE THE PATIENT WAS SEWN UP. THE SURGEON REMOVED DEVICE AND RE-DRILLED AND COMPLETED THE PROCEDURE OVER AGAIN TO REINSERTED THE BLADE IN THE PROPER PLACE. A SECOND X-RAY WAS TAKEN AND THE SURGEON WAS SATISFIED WITH POSITION BASED ON FLUOROSCOPY IMAGES. A SURGICAL DELAY OF 30 MINUTES WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS DISCOVERED POSTOPERATIVELY THROUGH X-RAY ON AN UNKNOWN DATE SHORTLY AFTER THE INITIAL PROCEDURE THAT THE BLADE CUT OUT. THE FRACTURE LOST REDUCTION. A REVISION SURGERY OCCURRED ON (B)(6) 2017. PATIENT WAS REVISED TO A TOTAL HIP ARTHROPLASTY (THA). THIS REPORT ADDRESSES THE INTRAOPERATIVE EVENT. THE REVISION PROCEDURE IS ADDRESSED IN (B)(4). CONCOMITANT DEVICES REPORTED: 135 DEGREE LCP DHHS SIDEPLATE-STANDARD BARREL 4 HOLES (282.612, LOT 7832545, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HELIX B

  Patient problems: No Code Available

  MAUDE report 7039339 ↗