GAMMA 3325-0400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613153313564), received between Nov 16, 2016 and Aug 10, 2018 — 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.

• InjuryAug 10, 2018Insufficient Device Problem Information

  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 PRIMARY OSTEOARTHRITIS. CASE 231 OUT OF 290 CASES.

  Patient problems: Arthritis

  MAUDE report 7773642 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem

  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 OSTEOSYNTHESIS FAILURE. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. TWO HUNDRED AND TWENTY-SIX OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7773475 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem

  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 OSTEOSYNTHESIS FAILURE. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. 154 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 7771641 ↗
• 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 OSTEOSYNTHESIS FAILURE. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. SIXTEEN OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771585 ↗
• InjuryAug 10, 2018Failure to Osseointegrate

  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 OSTEOSYNTHESIS FAILURE. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 5 OUT OF 290 CASES.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7771581 ↗
• InjuryOct 6, 2017Break

  LAWYER OF PATIENT REPORTS THAT ON (B)(6) 2016 PATIENT HAD SURGERY DUE TO FEMORAL NECK FRACTURE. THE REPORTED NAIL WAS IMPLANTED. THEREAFTER, THE PATIENT DID NOT HURT HIMSELF, DID NOT FALL, ETC, YET FELT PAIN AND RETURNED TO THE HOSPITAL. ON (B)(6) 2016 IT WAS DISCOVERED THAT THE NAIL WAS BROKEN.

  Patient problems: Pain

  MAUDE report 6919497 ↗
• InjuryNov 16, 2016Break

  IT WAS REPORTED THAT GAMMA NAIL BROKE.

  Patient problems: No Information

  MAUDE report 6105564 ↗