GAMMA 3325-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613153313496), received between Aug 10, 2018 and May 9, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT PATIENT STUMBLED ON (B)(6) 2018 BEHIND HER WALKER AND FELL ON HER COUCH. SHE HAD SUSTAINED A "SUB PERTROCHANTER FRACTURE". AN ELONGATED GAMMA3 NAIL WAS PLACED IN AN 71-YEAR-OLD FEMALE PATIENT AT (B)(6) 2018, POSITION: LEFT PROXIMAL FEMUR. POST SURGICAL PROTOCOL: MOBILIZATION IN RELIANCE ON PAIN: PATIENT USED A WALKER FOR MOVEMENT. AFTER THE INITIAL SURGERY THE PATIENT COULD START CAREFULLY LOAD HER INJURED LEG AGAIN FOLLOWING NORMAL PROTOCOL PATIENT DIDN¿T FALL NOR JUMP NOR DID ANYTHING ELSE THAT COMPROMISED HER HEALTH AND RECOVERY. IN THE FIRST WEEK OF APRIL SHE DEVELOPED PAIN IN HER LEFT HIP WHICH PERSISTED ALREADY A FEW DAYS. ON THE 9TH AN X-RAY WAS TAKEN. THE NAIL SEEMED TO BE BROKEN. THAT DAY OR NURSE, GOT IN TOUCH TO INVESTIGATE WHAT INSTRUMENTS WHERE AVAILABLE FOR EXTRACTING THE BROKEN NAIL AND THE REVISION OR WAS PLANNED ON THE (B)(6) APRIL.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 8597225 ↗
• InjuryJan 7, 2019Break

  THE DOCTOR REPORTED TO SALES REP THAT A PATIENT DID A REVISION SURGERY DUE TO FACT THE FIRST NAIL HAD BEEN BROKEN AFTER 2-3 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: No Information

  MAUDE report 8223906 ↗
• InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available

  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 GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POSTOPERATIVE 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 SEQUELAE AFTER HIP FRACTURE. THE 129 OUT OF 290 CASES.

  Patient problems: No Information

  MAUDE report 7779753 ↗
• InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

  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 SEQUELAE AFTER PROXIMAL FEMUR. CASE 261 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7773640 ↗
• InjuryAug 10, 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 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 CUTOUT. THE 218 OUT OF 290 CASES. IT WAS ALSO INDICATED THAT PATIENT DIED WITHIN 60 DAYS OF REVISION SURGERY HOWEVER THE CAUSE AND DATE OF DEATH WILL NOT BE DISCLOSED.

  Patient problems: Death

  MAUDE report 7773051 ↗
• 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 CUTOUT AND NEW FRACTURE AROUND IMPLANT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. CASE 82 OUT OF 290 CASES.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7773037 ↗
• InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(4) 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 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 UNKNOWN REASON. TWENTY-THREE OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7772212 ↗