GAMMA 3520-0320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540375599), received between Jan 4, 2019 and Nov 1, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

• InjuryNov 1, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "NAIL FRACTURE ASSOCIATED WITH PSEUDOARTICULATION".

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15707264 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THE PATIENT PROGRESSING TO AVASCULAR NECROSIS. A GAMMA3 NAIL CONSTRUCT WAS REVISED TO A TOTAL HIP. "

  Patient problems: Necrosis

  MAUDE report 11586389 ↗
• InjuryJan 4, 2019Fracture

  ON (B)(6) 2016, LONG GAMMA NAIL WAS IMPLANTED AS A TREATMENT FOR TROCHANTER FRACTURE. PARTIAL LOAD WAS STARTED 1 WEEKS LATER AFTER SURGERY AND TOTAL LOAD STARTED AT 9 WEEKS. FELT SOMETHING STRANGE IN (B)(6) 2018, VISITED THE HOSPITAL ON (B)(6) 2018. FRACTURE OF THE PROXIMAL PART OF THE NAIL WAS DISCOVERED COMPARED WITH RADIOGRAPHING. IT WAS REPLACED ON (B)(6) WITH A REPLACEMENT OF LONG GAMMA ((B)(4)). AFTER (B)(4), WHEN SHE PRESENT TO DOCTOR AT (B)(6) 2018, FRACTURE WAS CONFIRMED AT PROXIMAL PART OF THE NAIL. THEREFORE, THE NAIL WAS REMOVED AND FIXED WITH NO STRYKER PLATE TO CALM THE INFLAMMATORY RESPONSE WITH ANTIBIOTICS. AFTER THAT, THE BIPOLAR HIP ARTHROPLASTY IS "PLANED".

  Patient problems: Inflammation

  MAUDE report 8220016 ↗