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MULTILOC 04.019.225SRecalls & reported problems

Synthes GmbH · 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/225MM-STERILE · Class 2 · Implant

All models of MULTILOC (48)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982090072), received between Nov 9, 2020 and Oct 21, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Migration1

Patient problems

  • No Code Available1
  • Post Operative Wound Infection1
  • Skin Inflammation/ Irritation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A FRACTURE FIXATION OF THE LONG BONES OCCURRED. THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/225MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: Post Operative Wound Infection

    MAUDE report 15652922 ↗
  • InjuryOct 21, 2022Migration; Migration

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS FRACTURE FIXATION OF THE LONG BONES. SEMI-PROMINENT NAIL WAS THERE. THE PATIENT WAS ABLE TO FEEL "PROTRUSION" OF NAIL. THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/225MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 15649971 ↗
  • InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE AND REMOVAL OF THE MULTI LOCK FEMORAL NAIL. THE IMPLANT REMOVAL WAS DUE TO THE QUALITY OF IMPLANTS AND NON-UNION. INITIALLY, PATIENT HAD A ZIMMER BIOMET PROXIMAL HUMERUS PLATE THAT WAS REVISED TO SYNTHES MULTILOC HUMERAL NAIL DUE TO ZIMMER PLATE FAILURE. IT WAS ALSO MENTIONED THAT THE PATIENT HAD AN INFECTION PRIOR TO SURGICAL IMPLANT THAT ULTIMATELY LED TO THE NON-UNION. DURING THE PROCEDURE, THE FEMORAL IMPLANT WAS REMOVED AHEAD PROXIMAL NAIL TO GET THE PROXIMAL SCREW STILL INTACT. THE PATIENT WAS THEN REVISED TO A REVERSE SHOULDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/225MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 10810301 ↗

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Sources and updates

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