GAMMA 3325-0420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613153313588), received between Aug 10, 2018 and Aug 21, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2018Crack

  THE CUSTOMER REPORTED THAT A GAMMA NAIL WHICH HAD BEEN IMPLANTED ON (B)(6) 2018 WAS REVISED ON (B)(6) 2018. THE SURGEON REPORTED A POOR REDUCTION DUE TO THE FRACTURE PATTERN AND ALSO MEDIAL BONE LOSS IN THE LESSER TROCHANTER. THE PATIENT WAS REVISED TO A PROXIMAL FEMORAL PLATE. UPDATE: THE CUSTOMER REPORTED THAT THE PATIENT TURNED AND HEARD A CRACK. SHE DID NOT FALL. PATIENT PRESENTED TO CLINIC. PATIENT HAD NON-UNION PRIOR TO THIS REPORTED EVENT. REVISION SURGERY COMPLETED "USCCESSFULLY."

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis

  MAUDE report 7803316 ↗
• InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(6) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN (B)(6) 2005 AND (B)(6) 2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY (RE-OSTEOSYNTHESIS) DUE TO UNKNOWN REASON. ABOUT 28 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7778706 ↗
• InjuryAug 10, 2018Fracture

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO A NEW FRACTURE AROUND IMPLANT. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 14 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771584 ↗