GAMMA 3225-0320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613153312734), received between Jun 12, 2018 and Dec 13, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2021Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA NAIL WHICH REQUIRED A REVISION SURGERY ON (B)(6) 2021. 11/25/2021 - ADDITIONAL INFORMATION RECEIVED: THE PATIENT PRESENTED ON (B)(6) 2021 WITH PAIN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12984954 ↗
• InjuryMar 10, 2020Fracture; Fracture

  IT WAS REPORTED: BREAKAGE OF THE NAIL IN CORRESPONDENCE OF THE SLOT THAT ALLOWS THE PASSAGE OF THE CEPHALIC SCREW, DETECTED EVENT IN THE RADIOGRAPHY. UNANTICIPATED MEDICAL PROCEDURE OCCURRED AS A RESULT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9813238 ↗
• InjuryMay 9, 2019Defective Device; Positioning Problem

  THE FOLLOWING REPORT WAS RECEIVED FROM THE ITALY COMPETENT AUTHORITY ORG. (MOH): DURING THE REMOVAL OF A GAMMA NAIL LONG, USED TO REDUCE A MULTIFRAGMENTED RIGHT FEMUR FRACTURE, DISTALLY AND PROXIMALLY BLOCKED, THE SURGEON HAS NOTICED VISIBLE SIGNS OF RUBBING OF THE CEPHALIC SCREW ON THE NAIL IN AN ABNORMAL LOCATION: OUT OF THE CHANNEL THAT NORMALLY HOUSES THE CEPHALIC SCREW. THE SYSTEM IS NORMALLY USED PERCUTANEOUSLY, SO WITHOUT A DIRECT VIEW OF THE OPERATOR BUT ONLY VIA RX. THE SYSTEM IS COLLIMATED BY CANNULAS THAT ALLOW THIS PROCEDURE. SO CUSTOMER REPORTS THAT THE INCIDENT IS INEXPLICABLE EXCEPT WITH AN ALLEGED DEFECT IN THE INSTRUMENTS. ADVERSE EVENT: ASYMMETRY, LACK OF BONE CALCIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8596807 ↗
• InjuryOct 1, 2018Fracture

  IN THE CASE OF A SUBTROCHANTERIC FRACTURE OF THE RIGHT FEMUR, A LONG GAMMA LOCKING NAIL WAS IMPLANTED ON (B)(6) 2016. FURTHER TREATMENT WAS CARRIED OUT BY THE FAMILY DOCTOR OF THE PATIENT. AT FIRST THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2018. EXTERNALLY TAKEN X-RAY IMAGES DATED (B)(6) 2018 WERE PRESENTED SHOWING A FRACTURE IN THE PROXIMAL PORTION OF THE GAMMA LOCKING NAIL AT THE POINT OF PASSAGE OF THE FEMORAL NECK SCREW. EVIDENCE OF INSUFFICIENT BONE HEALING OF THE PROXIMAL FEMUR FRACTURE (PSEUDARTHROSIS FORMATION). COUNTERMEASURES TAKEN / ASSISTANCE: WITH KNOWLEDGE OF INSUFFICIENT BONE HEALING - COMBINED WITH A FRACTURE OF THE PROXIMAL NAIL END - A REVISION SURGERY WAS NECESSARY WHICH WAS STRESSFUL FOR THE PATIENT. THE NAIL SYSTEM WAS COMPLETELY REMOVED, THE NONUNION REPAIRED AND A NEW DRILLED DYNAMICALLY LOCKED GAMMA NAIL WAS INSERTED. TEMPORARILY INTENSIVE MEDICAL CARE UNTIL STABILIZATION OF THE GENERAL CONDITION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7923907 ↗
• InjuryAug 14, 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 (B)(4) 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; 100 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 7780005 ↗
• InjuryAug 13, 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 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 (RE-OSTESYNTHESIS) DUE TO UNKNOWN REASON. THE 175 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7779770 ↗
• InjuryAug 13, 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 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 A NEW FRACTURE AROUND IMPLANT. RE-OSTESYNTHESIS WAS PERFORMED. THE 15 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7778670 ↗
• 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 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 NONUNION. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. CASE 41 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 7777814 ↗
• 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 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 (RE-OSTEOSYNTHESIS) DUE TO UNKNOWN REASON. CASE 42 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7777702 ↗
• 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 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 DEEP INFECTION. CASE 21 OUT OF 290 CASES.

  Patient problems: Unspecified Infection

  MAUDE report 7777597 ↗
• InjuryJun 12, 2018Fracture; Fracture

  IT WAS REPORTED BY THE END USER THAT 3 WEEKS AFTER THE MEDICAL PROCEDURE, WHILE THE PATIENT WAS WALKING, SHE HEARD A 'CRACK' NOISE FROM HER HIP. AT THE HOSPITAL THEY FOUND THAT THE NAIL WAS BROKEN. THE NAIL WAS REPLACED ON ANOTHER SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 7593473 ↗