GAMMA 3325-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613153313519), received between Jan 27, 2017 and Jan 11, 2019 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2018, AN OSTEOSYNTHESIS OF A SUBTROCHANTERIC FEMUR FRACTURE USING A LONG NAIL WAS PERFORMED IN DOMO. ON (B)(6) 2018 THE PATIENT PRESENTED WITH INCREASING PAIN IN THE LEFT HIP, WITHOUT A TRAUMA HAD PRECEDED.

  Patient problems: Pain

  MAUDE report 8242305 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem

  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. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY AND RE-OSTEOSYNTHESIS WAS PERFORMED. THE 111 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 7780863 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem

  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. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. THE 278 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 7780451 ↗
• InjuryAug 14, 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, 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 MALUNION. RE-OSTESYNTHESIS WAS PERFORMED. THE 151 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780104 ↗
• 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, 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. THE 59 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7778916 ↗
• 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 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. TEN (10) OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7778565 ↗
• InjuryAug 10, 2018Fracture

  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, CUTOUT AND NEW FRACTURE AROUND IMPLANT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. TWO HUNDRED AND TEN 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 7773467 ↗
• InjuryAug 10, 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 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 AND SEQUELAE AFTER HIP FRACTURE. CASE 153 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7773461 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information

  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 MALUNION. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. THIRTY-ONE (31) OUT OF 290 CASES.

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7772216 ↗
• 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 (DRAINAGE) DUE TO INFECTION. CASE 18 OUT OF 290 CASES.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 7772146 ↗
• InjuryJul 2, 2018Break; Fracture

  IT WAS REPORTED THAT NAIL WAS IMPLANTED ON (B)(6) 2018 BECAUSE OF A SUBTROCHANTERIC FEMUR FRACTURE. PATIENT CAME IN WITH BROKEN NAIL. FOLLOW-UP WAS WITHOUT ANY PROBLEMS, HOWEVER ON (B)(6) 2018 THE PATIENT CAME IN WITH A BROKEN NAIL (RIGHT LEG).

  Patient problems: No Code Available

  MAUDE report 7656885 ↗
• InjuryFeb 7, 2017Fracture; Fracture

  IT WAS REPORTED THAT IN THE REVISION DUE TO A BOLT BREAK AND NAIL FRACTURE ON (B)(6) 2016 AN ATROPHIC PSEUDOARTHROSIS WAS FOUND. LOCKING SCREW WAS ALSO FOUND TO BE BROKEN.

  Patient problems: No Code Available

  MAUDE report 6308520 ↗
• InjuryJan 27, 2017Insufficient Device Problem Information

  THE SURGEON REPORTED: SUDDEN COLLAPSE OF THE LEFT LOWER LIMB AND FUNCTIONAL IMPOTENCE. THE PATIENT ARRIVED AT THE HOSPITAL WITH X-RAY RESPONSE OF THE RUPTURE OF THE NAIL GAMMA LONG. DURING SURGERY REVISION IT WAS CONFIRMED THE RUPTURE OF THE NAIL AND DETECTION OF NON-UNION OF THE FRACTURE (DELAYED HEALING).

  Patient problems: Bone Fracture(s); Rupture

  MAUDE report 6283418 ↗