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DHHS 282.612Recalls & reported problems

Synthes GmbH · 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982178701), received between Nov 26, 2019 and Nov 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device-Device Incompatibility1

Patient problems

  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS SURGICAL SITE INFECTION POSTOPERATIVE COMPLICATIONS REPORTED. PATIENT STATUS/ OUTCOME? FRACTURE UNITED AFTER REVISION WITH ANTIBIOTIC COATED IMN. THIS REPORT IS FOR ONE (1) 135 DEG LCP DHHS SIDEPL-STD BRL 4 H THIS IS REPORT 1 OF 5 FOR COMPLAINT ((B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 15801621 ↗
  • MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR USING A DYNAMIC HELICAL HIP SYSTEM (DHHS). THE HELICAL/HELIX BLADE WAS INSERTED IN A NORMAL FASHION. AS THE SURGEON WENT TO KEY IN THE HELICAL BLADE, THE HELICAL BLADE OVER-INSERTED. WHEN THE SURGEON TRIED TO BACK UP THE HELICAL BLADE, IT WOULD NOT SLIDE THROUGH THE PLATE/SIDE PLATES STANDARD BARREL. THE HELICAL BLADE AND THE PLATE WERE REMOVED IN A SINGLE PIECE AND A NEW HELICAL BLADE AND PLATE WERE REINSERTED WITHOUT INCIDENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 9377755 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.