GAMMA 3225-0380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613153312796), received between Apr 21, 2017 and Dec 12, 2019 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Fracture; Fracture

  SALES REP REPORTED THE FOLLOWING: I JUST HAD [SURGEON] ON THE PHONE. HE PLACED A LONG GAMMA3 TITANIUM L 380 NAIL IN (B)(6) 2019 IN A 1M65 WOMAN. (B)(6) KG AND THE NAIL BROKE IN (B)(6) 2019. HE PUT A GAMMA NAIL BACK ON. NO FALLS OR TRAUMA THAT WOULD HAVE CAUSED THIS CONCERN. HE MADE A DECLARATION OF MATERIAL VIGILANCE. HE KEPT THE NAIL. THE REVISION SURGERY (EXPLANTATION OF A BROKEN NAIL REPLACED BY AN IDENTICAL ONE) WAS COMPLETED CORRECTLY. CLINICAL CONSEQUENCE FOR THE PATIENT: SUDDEN PAIN, IMPOTENCE OF SUPPORT, HAD TO "UNDERGO" AN ADDITIONAL PROCEDURE. INTERVENTION DELAYED BY A FEW DAYS BETWEEN THE RUPTURE AND THE INTERVENTION (TIME TO SCHEDULE THE SURGERY AND POSSESS THE EQUIPMENT) PATIENT AGED 67 YEARS OLD RETIRED, WITHOUT RISKY ACTIVITY OR OVERWEIGHT. THERE WERE NO CONDITIONS OF IMMOBILIZATION AFTER THE FIRST INTERVENTION AND THE PURPOSE WAS TO GIVE BACK SUPPORT TO WHAT WAS ACHIEVED. THE PATIENT BECAME AWARE OF THE PROBLEM ON (B)(6) 2019 DUE TO THE OCCURRENCE OF SUDDEN HIP PAIN. FRAGILITY DUE TO METASTATIC LESION IN THE TROCHANTERIC REGION. NAIL IMPLANTED AS A PREVENTIVE MEASURE IN FRONT OF A PAINFUL SECONDARY HIP LESION VISIBLE ON TEP SCAN BUT NOT ON SIMPLE RX. FIRST IMPLEMENT

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Failure of Implant; Injury; Pain

  MAUDE report 9462153 ↗
• InjuryOct 18, 2018Break

  THERE WAS A MATERIAL BREAKAGE OF THE NAIL IN THE HOLE OF THE FEMORAL NECK SCREW 10 MONTHS AFTER IMPLANTATION. THERE WAS A CHANGE TO A MODULAR PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7982084 ↗
• 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 OSTEOSYNTHESIS FAILURE. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. THE 141 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 7779742 ↗
• 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 SEQUELE AFTER PROXIMAL FEMUR. ONE 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 7773042 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information

  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 MALUNION. TWO HUNDRED 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: Bone Fracture(s); Death

  MAUDE report 7771772 ↗
• 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 AND SEQUELAE AFTER HIP FRACTURE. CASE 164 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771684 ↗
• 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 191 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 7771682 ↗
• InjuryAug 10, 2018Fracture

  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 AND NEW FRACTURE AROUND IMPLANT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. ONE-HUNDRED EIGHTY-NINE (189) OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771678 ↗
• 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 (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 (B)(4) 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. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7771637 ↗
• InjuryAug 10, 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, 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 DUE TO UNKNOWN REASON. 1 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771563 ↗
• InjuryApr 21, 2017Break

  IT WAS REPORTED THAT PATIENT FALL ON ICE AND FRACTURE SUBTROCH. ON (B)(6) 2016, GAMMA NAIL WAS IMPLANTED ON (B)(6) 2016, NO TRAUMA, INCREASING PAIN DURING GARDEN WORK, MATERIAL REMOVAL AND IMPLANTATION OF A LONG GAMMA NAIL (B)(6) 2016, INCREASING PAIN FOR 2 WEEKS, NAIL BREAKAGE, REVISION WITH A FRIEDEL NAIL ON (B)(6) 2017.

  Patient problems: Fall; No Code Available; Pain

  MAUDE report 6513409 ↗