NorianRecalls & reported problems across all models

We found 5 models of Norian by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2018 and Apr 28, 2023 — classified as 4 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Norian problems

Norian models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Norian 07.704.005S

  FILLER, BONE VOID, CALCIUM COMPOUND
  25 reports
• Norian 07.704.010S

  FILLER, BONE VOID, CALCIUM COMPOUND
  15 reports
• Norian 07.704.003S

  FILLER, BONE VOID, CALCIUM COMPOUND
  7 reports
• Norian 07.704.110S

  FILLER, BONE VOID, CALCIUM COMPOUND
  5 reports
• Norian 07.704.105S

  FILLER, BONE VOID, CALCIUM COMPOUND
  4 reports

Recent Norian adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN INTRA-OP AFTER THE NORIAN WAS MIXED, IT WAS PUT THROUGH THE ROLLING PRESS IN NORMAL FASHION. INSTEAD OF PUSHING THE NORIAN INTO THE SYRINGE, IT SQUEEZED OUT INTO THE PACKAGE MAKING IT UNUSABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TWO MINUTES OF SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16840272 ↗
• MalfunctionApr 19, 2023Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE NORIAN FAST SET PUTTY SOLIDIFIED TOO QUICK. IT COULD NOT INSERT THROUGH DELIVERY DEVICE. COMPETITOR'S EQUIPMENT WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 10CC-S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773283 ↗
• MalfunctionApr 19, 2023Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE NORIAN FAST SET PUTTY SOLIDIFIED TOO QUICK. IT COULD NOT INSERT THROUGH DELIVERY DEVICE. COMPETITOR'S EQUIPMENT WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 5CC-SILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773276 ↗
• MalfunctionJan 11, 2023Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON REQUESTED TO USE 5CC OF NORIAN. AS THE CIRCULATING NURSE WAS PREPARING THE BONE VOID FILLER BY TWISTING THE SOLUTION SYRINGE INTO THE INJECTABLE PORT. THE PORT CRACKED AND THE SOLUTION LEAKED AS IT WAS INSERTED. NO PASTE WAS CREATED OR USED. THERE WAS NO SURGICAL DELAY AND NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138692 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DISLOCATED 2 FRAGMENT PROXIMAL HUMERUS FRACTURED, AND THERE WAS INCISIONAL SEROMA (INFECTION). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4)..

  Patient problems: Joint Dislocation; Seroma

  MAUDE report 15649897 ↗
• MalfunctionSep 9, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE (B)(6) 2022, WHEN ATTEMPTED TO MIX NORIAN, THE CONNECTION BETWEEN THE SYRINGE THAT CONTAINS THE MIXING SOLUTION AND THE NORIAN ITSELF, WOULD NOT LOCK PROPERLY, CAUSING SOME OF THE SOLUTION TO LEAK OUT. WE ATTEMPTED TO COMPLETE THE MIXING BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 6MIN OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396677 ↗
• MalfunctionSep 1, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2022, NORIAN DRILLABLE INJECT 3CC WAS TO BE USED DURING THE CASE, STEPS WERE FOLLOWED ACCORDINGLY PER TECHNIQUE GUIDE. AFTER THE MIXING CYCLE THE ROTARY POUCH WAS PLACED INTO THE TRANSFER ROLLER. THE ROLLER WAS TURNED COUNTERCLOCKWISE THE FULL LENGTH OF THE POUCH AND NO PASTE WAS DELIVERED INTO THE SYRINGE. THEREFORE, ANOTHER NORIAN DRILLABLE HAD TO BE USED TO COMPLETE THE CASE WITH NO ISSUES. THERE WAS 5 MINS OF SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR A NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338449 ↗
• MalfunctionAug 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SODIUM HYALURONATE SOLUTION WAS SQUIRTING OUT OF THE ROTARY INJECTION PORT OF THE NORIAL DRILLABLE INJECT. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275655 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT HAD REPAIR LEFT FEMUR MALUNION/NONUNION WITH AUTO GRAFT AND BONE GRAFTING LEFT FEMORAL HEAD. ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF HARDWARE HIP (LEFT) CONVERSION, PREVIOUS HIP SURGERY TO TOTAL HIP ARTHROPLASTY (LEFT). OPERATIVE FINDINGS WITH NON UNION FAILED TFN, LEFT SUPERIOR ACETABULAR DEFECT. ON (B)(6) 2020 PATIENT HAD UNDERGONE IRRIGATION AND DEBRIDEMENT HIP (LEFT) - PROSTHETIC HIP INFECTION. CONCOMITANT : TRIGEN INTERTAN 11.5MM X 18CM 125DEGREE (PART 71675202 LOT 19LMD7004,QUANTITY#1) INTERTAN LAG/COMPRESSION SCREW KIT 85MM / 80MM (PART 71677085 LOT 17BT8266, QUANTITY#1) TRIGEN (PART71645030 LOT 20320696,QUANTITY#1). THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15208387 ↗
• MalfunctionAug 2, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE MIXING 5CC OF NORIAN, CORRECT APPLICATION OF SOLUTION, REMOVED CAP, MIXED FOR 30 SECONDS. NORIAN WOULD NOT TRANSFER TO SYRINGE. THERE WERE A SURGICAL DELAY OF 10 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149249 ↗
• MalfunctionMay 26, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT THE CONSISTENCY OF NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE WAS OFF AND WAS NOT MIXING CORRECTLY. IT WAS REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR THE FAST SET PUTTY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520019 ↗
• MalfunctionMay 5, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. THE LIQUID SOLUTION FROM THE NORIAN SYRINGE WOULD NOT INJECT INTO THE ROTARY POUCH INJECTION PORT, INSTEAD SPILLING OUT ALL OVER THE MIXER AND TABLE, EVEN THOUGH CARE WAS TAKEN TO ENSURE THE SYRINGE WAS SECURELY ATTACHED TO THE PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTES OF SURGICAL DELAY NOTED. NO FRAGMENTS WERE GENERATED. NO PATIENT OUTCOME WAS REPORTED. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286884 ↗
• MalfunctionMar 3, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A UNKNOWN PROCEDURE. IN A BILATERAL CALCANEUS FRACTURE CASE WE WENT TO PUT 10CC'S OF NORIAN IN ONE SIDE. WHILE MIXING THE DOC BROKE OFF THE ANTERIOR PROCESS OF THE CALCANEUS AND I WENT RUNNING FOR PLATES. IN THIS TIME THE NORIAN WAS OPENED WITHOUT HAVING BEEN ROLLED INTO THE SYRINGE AND WAS LEFT TO HARDEN IN THE PACKAGE. WE ULTIMATELY OPENED ANOTHER BOX AND USED THAT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTES OF SURGICAL DELAY NOTED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660630 ↗
• MalfunctionJan 13, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE NORIAN DRILLABLE INJECT 3CC WAS MIXED WITH ROTARY MIXER IN A CASE. ALL STEPS WERE FOLLOWED PROPERLY, TEMPERATURE INDICATOR WAS GOOD AS WELL AS EXPIRATION DATE; HOWEVER, NO INJECTABLE BONE VOID FILLER CAME OUT WHEN IT WAS PULLED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254377 ↗
• MalfunctionDec 7, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, THE NORIAN MIXING SOLUTION LEAKED OUT WHILE INJECTING. THE PROCEDURE WAS CONCLUDED USING A NEW 10CC NORIAN KIT. THERE WERE THREE (3) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 1 OF 1 OR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956777 ↗

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