GAMMA 3060-0095SRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04546540374936), received between Jul 27, 2018 and Aug 8, 2024 — classified as 66 injuries.

The most frequently reported specific device problem is “Fracture” (10 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938370 ↗
• InjuryJun 3, 2024Migration; Migration

  THE CUSTOMER REPORTED TO THE FOLLOWING: "ON (B)(6)2023, AN ORTHOPAEDIC SURGEON AT OUR HOSPITAL, TREATED AN 80-YEAR-OLD PATIENT FOR A PER TROCHANTERIC FRACTURE OF THE RIGHT FEMUR, FOR WHICH HE RECOMMENDED SURGERY WITH A GAMMA STRYKER NAIL. POSTOPERATIVE RECOVERY WAS STRAIGHTFORWARD, WITH SATISFACTORY FOLLOW-UP X-RAYS. THE PATIENT WAS SEEN AGAIN AT 6 WEEKS, WITH NO PARTICULARITIES, AND GRADUALLY RETURNED TO FULL WEIGHT-BEARING. THE PATIENT WAS NOT SEEN AGAIN AT 3 MONTHS; HE WAS REFERRED TO OUR ESTABLISHMENT'S EMERGENCY DEPARTMENT FOR REPEATED FALLS AND CONFUSION ON (B)(6)2024. ON (B)(6)2024, THE SURGEON NOTED ON THE X-RAY TAKEN ON ADMISSION THAT THE CERVICAL SCREW OF THE TROCHANTERIC NAIL HAD LITERALLY "SELF-SCREWED" THROUGH THE JOINT SPACE AND ENDED UP AGAINST THE QUADRILATERAL BLADE OF THE PELVIS. THE SURGEON NOTED: MOBILISATION OF THE CERVICAL SCREW OF THE TROCHANTERIC NAIL OF THE TROCHANTERIC NAIL HAVING LITERALLY "SELF-CREVISED" TO CROSS THE JOINT SPACE AND FINISH ITS COURSE AGAINST THE QUADRILATERAL BLADE OF THE PELVIS, I.E. IT HAS NOT "YET" PENETRATED THE PELVIS. ON CLINICAL EXAMINATION, THE HIP CAN BE MOVED IN BUT NOT IN MODERATELY SENSITIVE ROTATION. THE PATIENT WAS RUSHED T

  Patient problems: Confusion/ Disorientation; Failure of Implant; Fall; Perforation

  MAUDE report 19448437 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "CUT-OUT OF THE FEMORAL NECK SCREW WITH THE GAMMA NAIL LYING ON THE RIGHT. PATIENT WAS IN PAIN AND UNDERWENT A REVISION SURGERY."

  Patient problems: Implant Pain; Perforation

  MAUDE report 17025955 ↗
• InjuryJul 12, 2019Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE, AND BREAKAGE OF THE NAIL AT THE FRACTURE SITE. PATIENT WAS REVISED TO COMPETITOR DEVICES.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8784556 ↗
• InjuryJun 25, 2019Material Deformation; Device Dislodged or Dislocated; Material Deformation

  GAMMA3 PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014. THIS TIME CUTOUT OF THE LAG SCREW WAS FOUND. IT IS UNKNOWN WHEN THE CUTOUT WAS OCCURRED. THE PATIENT HAS FELT PAIN BUT IS ABLE TO WALK. REVISION SURGERY TO THA WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8732812 ↗
• 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 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 AND CUTOUT. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. THE 237 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 7781161 ↗
• 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 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 MALUNION. RE-OSTEOSYNTHESIS WAS PERFORMED. THE 248 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; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7781026 ↗
• 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 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. THE 254 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 7780956 ↗
• InjuryAug 14, 2018Fracture; Failure 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 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 178 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; Inadequate Osseointegration

  MAUDE report 7780951 ↗
• InjuryAug 14, 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 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. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. THE 166 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 7780947 ↗
• InjuryAug 14, 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 PROXIMAL FEMUR. THE 137 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 7780887 ↗
• InjuryAug 14, 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. THE 127 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; Discharge; Unspecified Infection

  MAUDE report 7780869 ↗
• 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 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 CUTOUT. THE 234 OUT OF 290 CASES.

  Patient problems: Tissue Damage

  MAUDE report 7780802 ↗
• 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 MALUNION. RE-OSTEOSYNTHESIS WAS PERFORMED. THE 255 OUT OF 290 CASES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7780477 ↗
• 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 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 HIP FRACTURE. THE 223 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780436 ↗
• InjuryAug 14, 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 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. 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; Inadequate Osseointegration

  MAUDE report 7780422 ↗
• 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 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 HIP FRACTURE. THE 214 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780389 ↗
• 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 SEQUELAE AFTER HIP FRACTURE. THE 199 OUT OF 290 CASES.

  Patient problems: Hip Fracture

  MAUDE report 7780374 ↗
• InjuryAug 14, 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 (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 SEQUELE AFTER HIP FRACTURE. THE 193 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: Hip Fracture

  MAUDE report 7780338 ↗
• 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 (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 SEQUELA AFTER HIP FRACTURE. ABOUT 186 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780161 ↗
• 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 (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 SEQUELAE AFTER HIP FRACTURE; 181 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780148 ↗
• InjuryAug 14, 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 (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; 174 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: Hip Fracture

  MAUDE report 7780125 ↗
• 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 MALUNION. RE-OSTESYNTHESIS WAS PERFORMED; 151 OUT OF 290 CASES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7780102 ↗
• 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 (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-OSTEOSYNTHESIS) DUE TO UNKNOWN REASON. ABOUT 142 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780083 ↗
• InjuryAug 14, 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 SEQUELA AFTER HIP FRACTURE. THE 147 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780081 ↗