GAMMA 3225-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613153312772), received between May 19, 2016 and Mar 21, 2019 — classified as 12 injuries.

The most frequently reported specific device problem is “Break” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2019Fracture; Appropriate Device Problem Term/Code Not Available; Fracture

  ON (B)(6) 2018 PRIMARY OPERATION TOOK PLACE DUE SUBTROCHANTER FEMORAL SHAFT FRACTURE WITH LARGE SHARD MEDIAL. OPEN REPOSITION AND CERCLAGES, PLACEMENT OF LONG GAMMA NAIL 125GR FOLLOWED BY TWINING OF CERCLAGES. NO SPECIFIC PROBLEMS MENTIONED. BY APPOINTMENT OPERATOR 100% TAXED MOBILIZATION FROM INTERVENTION, INITIALLY NO PROBLEMS WITH TAX. UNCOMPLICATED COURSE, WOUND HEALING ON (B)(6) 2019 WITHOUT TRAUMA PATIENT SUDDENLY STARTED TO EXPERIENCE BURDEN PAIN AND INABILITY. BROKEN GAMMA NAIL ON COLUMN HOLE AND DISLOCATION WAS OBSERVED, NO SIGNS INFECTION. ON (B)(6) 2019 OPERATION 2 PATIENT WAS REVISED BY REMOVING THE PEN AND SCREWS, NO SPECIFIC FEATURES, POSSIBLE SHARPENED COLUMN-HOLE PIN. SURGEON IMPLANTS NEW EXTENDED GAMMA NAIL 130GR, UNCOMPLICATED SURGERY. PREOPERATIVE CULTURES NEGATIVE.

  Patient problems: Pain

  MAUDE report 8441980 ↗
• InjuryMar 14, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available; Fracture

  THE HOSPITAL REPORTED TO THE SALES REP THE FOLLOWING EVENT: "REVISION SURGERY OF A GAMMA NAIL PLACED ON (B)(6) 2018 BECAUSE IT BROKE AND CAUSED THE PATIENT TO FALL. MEDICAL INTERVENTION TOOK PLACE ON 16/01 WITH NEW GAMMA NAIL PLACEMENT AND A BONE GRAFT.

  Patient problems: Fall

  MAUDE report 8422649 ↗
• InjuryOct 24, 2018Break

  IN (B)(6) 2016, THE PATIENT WAS UNABLE TO GET OUT OF THE CHAIR BECAUSE OF UNEXPECTED PAIN. BUT THIS WAS NOT PRECEDED BY AN ACCIDENT OR TRAUMA AND NOTHING UNUSUAL HAD HAPPENED. THE ORTHOPEDIST THEN PERFORMED ANOTHER CONTROL X-RAY. HERE YOU CAN SEE IN HEIGHT OF THE SCREW THAT THE IMPLANTED GAMMA NAIL IS BROKEN. THE BONE AROUND THE FRACTURE APPEARS COMPLETELY INTACT.

  Patient problems: Pain

  MAUDE report 8002746 ↗
• InjuryAug 13, 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, POSTOPERATIVE 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 (RE-OSTESYNTHESIS) DUE TO UNKNOWN REASON. TWO HUNDRED TWELVE (212) OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7779828 ↗
• 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 OSTEOSYNTHESIS FAILURE. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 229 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 7773641 ↗
• 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 SEQUELAE AFTER HIP FRACTURE. CASE 214 OUT OF 290 CASES.

  Patient problems: Bone Fracture(s)

  MAUDE report 7773046 ↗
• 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. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. CASE 206 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; Failure of Implant

  MAUDE report 7773045 ↗
• 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 (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 NEW FRACTURE AROUND IMPLANT AND AVASCULAR NECROSIS. RE-OSTEOSYNTHESIS WAS PERFORMED. 272 OUT OF 290 CASES.

  Patient problems: Necrosis

  MAUDE report 7771644 ↗
• 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 AND MALUNION. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. ONE HUNDRED AND SIX 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 7771629 ↗
• 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 (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 A NEW FRACTURE AROUND IMPLANT. RE-OSTESYNTHESIS WAS PERFORMED. THIRTY FOUR (34) OUT OF 290 CASES.

  Patient problems: Bone Fracture(s)

  MAUDE report 7771589 ↗
• 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 SEQUELAE AFTER PROXIMAL FEMUR. CASE 35 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771588 ↗
• InjuryMay 19, 2016Break

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL HAD BROKEN DUE TO NON UNION OF RIGHT FEMUR. THE PATIENT WAS ADMITTED ON (B)(6) 2015 FOLLOWING A FALL WHILE REACHING FOR CLOTHES OFF HER LINE WHEN SHE OVERBALANCED AND SUSTAINED A SUBTROCHANTERIC RIGHT FEMORAL FRACTURE WITH APPARENT BASAL NECK FRACTURE. SHE PROCEEDED TO CEPHALOMEDULLARY NAILING ON (B)(6) 2015. THE PATIENT WAS ADMITTED ELECTIVELY FOR REMOVAL OF A BROKEN GAMMA NAIL AND RENAILING OF NON UNION RIGHT PROXIMAL FEMUR (B)(6) 2015. THIS PROCEDURE WENT WITHOUT COMPLICATION AND SHE WAS MOBILISED FULLY WEIGHT BEARING AS ABLE. SHE WAS DISCHARGED HOME ON (B)(6) 2015.

  Patient problems: No Information

  MAUDE report 5667446 ↗