GAMMA 3060-0105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04546540374950), received between Aug 1, 2018 and Jan 3, 2025 — classified as 43 injuries.

The most frequently reported specific device problem is “Fracture” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Migration; Migration

  IT WAS REPORTED" THAT DURING PRIMARY SURGERY SURGEON INSERTED A GAMMA3 NAIL IN A PATIENT 4 WEEKS AGO AND THE SCREW FOR LOCKING THE CARRIER, BUT THE SCREW COULD NOT BE TURNED FORWARD. AS THE FRACTURE WAS IN A GOOD POSITION, SURGEON DECIDED NOT TO REPLACE IT. UNFORTUNATELY, THE CARRIER SCREW HAS NOW MOVED LATERALLY, AND HE HAD TO REPLACE THE NAIL AFTER ALL. THE INITIAL SURGERY WAS ON (B)(6) 2024, THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024 WHERE HE INSERTED A NEW GAMMA3 NAIL. HE DID NOT WANT TO EXTEND THE INITIAL SURGERY ON AN (B)(6) YEAR-OLD PATIENT. SURGEON THINKS THAT THIS IS A DYNAMIC SYSTEM AND THAT THE SCREW SHOULD PREVENT ROTATION. HOWEVER, IT IS STILL POSSIBLE FOR THE SUPPORT SCREW TO MIGRATE UP TO APPROX. 40% OF THE LENGTH OF THE SCREW."

  Patient problems: Failure of Implant

  MAUDE report 21072623 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO NON-UNION OF A FEMORAL NECK FRACTURE. PRE-OP X-RAYS ALSO SHOWED A BROKEN DISTAL SCREW. INTRA-OPERATIVELY, THE NAIL WAS FOUND TO BE BROKEN WHERE THE LAG SCREW PASSES THROUGH THE NAIL. PATIENT WAS REVISED TO A HEMI HIP CONSTRUCT INCLUDING A RESTORATION MODULAR STEM CONSTRUCT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17625262 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO INFECTION. A SHORT GAMMA FEMORAL NAIL, LAG SCREW, TOP LOCKING SCREW, AND DISTAL SCREW WERE REVISED TO A CEMENTED TOTAL HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13283007 ↗
• InjuryOct 12, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED VIA MEDWATCH MW5103685 THAT A SHORT TROCH NAIL REQUIRED A REVISION A YEAR POSTOPERATIVELY (ORIGINAL SURGERY 2020). THE TOP OF THE TROCH NAIL BROKE OFF AND THE LAG SCREW THROUGH THE NAIL BROKE. UPDATE-(B)(6) 2021. HIP STARTED HURTING & PRESENTED FOR APPT BECAUSE OF SHARP HIP PAIN ON (B)(6) 2021. REQUIRED SURGICAL PROCEDURE TO REMOVE BROKEN IMPLANTS. IMPLANTS WERE USED FOR AN OPEN REDUCTION INTERNAL FIXATION RIGHT HIP FRACTURE. UNABLE TO PROVIDE X-RAYS AND MEDICAL RECORDS WITHOUT PATIENT'S CONSENT. WALKER WHEN UP, 50% WEIGHT BEARING. AMBULATES WITH WALKER, LIVED INDEPENDENTLY PRIOR TO SURGERY.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12615886 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO AVASCULAR NECROSIS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED IMPLANTS. A GAMMA NAIL, SET SCREW, LAG SCREW, AND DISTAL SCREW WERE REVISED."

  Patient problems: Necrosis

  MAUDE report 11369170 ↗
• InjuryFeb 12, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THE LAG SCREW BACKING OUT AND CAUSING THE PATIENT PAIN. A 105MM LAG SCREW WAS REVISED TO AN 80MM LAG SCREW. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 9703520 ↗
• InjuryJun 18, 2019Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO METAL FATIGUE CAUSING THE GAMMA NAIL TO BREAK AT THE JUNCTION WITH THE LAG SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8709489 ↗
• InjuryDec 17, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT'S RIGHT FEMUR WAS REVISED. AS REPORTED BY THE REP "LAG SCREW CUT OUT". A GAMMA3 NAIL, LAG SCREW, AND LOCKING SCREW WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH AN LFIT V40 HEAD AND UHR BIPOLAR COMPONENT. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171150 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT FEMUR WAS REVISED DUE TO LATERAL HIP PAIN. A 10.5X105MM LAG SCREW WAS REVISED TO A 10.5X90MM LAG SCREW. REP HAS PROVIDED PRE-OP AND POST-OP X-RAYS AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON. REP INDICATED THAT HE DID NOT OBSERVE ANY DAMAGE TO THE NAIL. THE NAIL WAS NOT REVISED.

  Patient problems: Pain

  MAUDE report 7975456 ↗
• InjuryAug 7, 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, 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 NEW FRACTURE AROUND IMPLANT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. CASE 264 OUT OF 290 CASES.

  Patient problems: Bone Fracture(s)

  MAUDE report 7757221 ↗
• InjuryAug 7, 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 GAMMA 3 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 MALUNION. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 216 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 7757111 ↗
• InjuryAug 6, 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, 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 SEQUELE AFTER HIP FRACTURE. TWO HUNDRED AND TWENTY OUT OF 290 CASES.

  Patient problems: Hip Fracture

  MAUDE report 7751255 ↗
• InjuryAug 6, 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, 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 AND NEW FRACTURE AROUND IMPLANT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. ONE HUNDRED AND NINETY 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 7751222 ↗
• InjuryAug 6, 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, 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 SEQUELE AFTER PROXIMAL FEMUR. ONE HUNDRED AND SEVENTY-ONE OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7751218 ↗
• InjuryAug 6, 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, 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, NEW FRACTURE AROUND IMPLANT AND AVASCULAR NECROSIS. RE-OSTESYNTHESIS WAS PERFORMED 161 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 7751215 ↗
• InjuryAug 6, 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, 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 SEQUELE AFTER PROXIMAL FEMUR. ONE HUNDRED AND EIGHTY-FOUR 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 7751214 ↗
• InjuryAug 3, 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 DUE TO MALUNION. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 257 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 7748263 ↗
• InjuryAug 3, 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, 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 DUE TO MALUNION. RE-OSTESYNTHESIS WAS PERFORMED. THE 269 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 7748253 ↗
• InjuryAug 3, 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, 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 CUTOUT. TWO HUNDRED AND FORTY-NINE 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 7748177 ↗
• InjuryAug 3, 2018Fracture; Appropriate 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, 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 SEQUELE AFTER HIP FRACTURE. ONE HUNDRED AND EIGHTY 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 7748174 ↗
• InjuryAug 3, 2018Patient-Device Incompatibility; Appropriate 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 AVASCULAR NECROSIS. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 169 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 7748119 ↗
• InjuryAug 3, 2018Fracture; Mechanical 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 DUE TO OSTEOSYNTHESIS FAILURE AND NEW FRACTURE AROUND IMPLANT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. CASE 152 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 7748097 ↗
• InjuryAug 3, 2018Material Integrity 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, 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. ONE HUNDRED AND FIFTY-FOUR 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 7748003 ↗
• InjuryAug 3, 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, 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. RE-OSTEOSYNTHESIS WAS PERFORMED. REPORT 59 OUT OF 290 CASES.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7747929 ↗
• InjuryAug 3, 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, 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 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 7746910 ↗