TRAUMACEM 07.702.040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10886982262257), received between Mar 7, 2018 and Sep 9, 2026 — classified as 14 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a case a TFNA and Traumacem was used. After the cement was injected, towards the end of the case, the patient¿s blood pressure dropped. The doctors in the room were able to stabilize the patient, however their opinion is that there was a cement embolism. Sales rep do not have photo evidence that is the case, but the clinical behavior was considered to mimic a cement embolism.

  Patient problems: Embolism/Embolus

  MAUDE report 50695894 ↗
• MalfunctionFeb 6, 2026Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, THE PRODUCTS IN QUESTION WERE UNUSABLE BECAUSE THE CEMENT DID NOT COME OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON SAID THAT THERE WAS NO PARTICULAR PROBLEM WITH THE PROCEDURE. IT WAS CONFIRMED BY POSTOPERATIVE IMAGE THAT THE FENESTRATED BLADE WAS USED, SO THE CAUSE COULD NOT BE IDENTIFIED. THE SURGEON NOTED THAT IT IS POSSIBLE THAT THE PATIENT'S BONE QUALITY WAS QUITE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280257 ↗
• MalfunctionDec 22, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH TFNA. CEMENT WAS USED IN SURGERY, BUT IT LEAKED OUT FROM THE FEMORAL NECK. BECAUSE THE FRACTURE WAS A SO-CALLED INTRAMEDULLARY TYPE, THE ANTERIOR OF THE FEMORAL NECK WAS OPENED AND THE REDUCTION WAS PERFORMED MULTIPLE TIMES USING ELEVATOR AND K-WIRES, WHICH IS THOUGHT TO HAVE CREATED A HOLE IN THE ANTERIOR FEMORAL NECK WALL. 4CC OF CEMENT WAS INJECTED, BUT DURING THE INJECTION, ONLY THE AP IMAGE WAS OBSERVED, AND THE ML IMAGE WAS NOT. THE SURGEON TRIED FOR SOME TIME TO REMOVE THE LEAKED CEMENT FROM THE ANTERIOR USING A KOCHER AND A PUNCH BUT WAS UNABLE TO DO SO. THE DOCTOR DECIDED THAT THERE WAS NO PARTICULAR PROBLEM AND THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23863677 ↗
• MalfunctionNov 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE (ABOUT HALF A MONTH AGO), THE PATIENT UNDERWENT SURGERY WITH CM FORTIS (COMPETITOR¿S PRODUCT) FOR FEMORAL TROCHANTERIC FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE SURGERY, THE PATIENT DEVELOPED DISPLACEMENT OF THE FRACTURES, AND CUTOUT OF THE AS2 SCREW (COMPETITOR¿S PRODUCT) FROM THE FEMORAL NECK OCCURRED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. FOLLOWING THE REMOVAL OF THE CM FORTIS IMPLANTS, THE CAVITY AT THE LAG-SCREW SITE WAS FILLED WITH FINELY CRUSHED ALLOGRAFT BONE. THE TFNA BLADE WAS THEN INSERTED, AND CEMENT AUGMENTATION WAS PERFORMED. WHEN THE SURGEON INJECTED JUST UNDER 3 ML OF CEMENT, A SMALL AMOUNT OF CEMENT LEAKED OUT FROM THE HOLE AT THE AS2 SCREW CUTOUT SITE IN THE FEMORAL NECK. THE HOLE WAS UNDER THE ILIOFEMORAL LIGAMENT, AND THE SURGEON COVERED IT BY MANUAL COMPRESSION, THEN INJECTED JUST UNDER 1 ML OF CEMENT. THE SURGEON FELT THE CEMENT LEAKING OUT, SO HE TRIED TO REMOVE THE CEMENT. AFTER TRYING ALMOST 5 TO 8 MINUTES (BASED ON THE SURGEON¿S PERCEIVED TIME), THE REMOVAL OF THE CEMENT WAS UNSUCCESSFUL AND DISCONTINUED. SINCE THE AMOUNT OF CEMENT INJECTED WAS DEEMED SUFFICIENT, THE SURGEON DECIDED TO REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636264 ↗
• MalfunctionNov 13, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCESS OF INJECTING CEMENT INTO THE FEMORAL HEAD VIA A CANNULA FROM A SYRINGE, IT APPEARED THAT CEMENT WAS FLOWING INTO THE BLOOD VESSELS SURROUNDING THE FEMORAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547971 ↗
• MalfunctionOct 28, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH HANSSON PINLOC SYSTEM (A COMPETITOR¿S PRODUCT) FOR FEMORAL NECK FRACTURES. AFTER THE SURGERY, THE PATIENT SUFFERED A SUBTROCHANTERIC FRACTURE OF THE FEMUR AND UNDERWENT REVISION SURGERY ON (B)(6) 2025. IN THE REVISION SURGERY, THE HANSSON PINLOC PRODUCT WAS REMOVED, REPLACED WITH TFNA IMPLANTS, AND CEMENT WAS USED. THE SURGEON INSERTED THE GUIDE PIN UP TO 10 MM BEFORE THE CARTILAGE CALLUS TO PREVENT IT FROM PENETRATION AND INSERTED THE BLADE UP TO 10 MM BEFORE THE CARTILAGE CALLUS. AFTER THAT, WHEN THE CEMENT WAS INJECTED, A SMALL AMOUNT (ABOUT THE SIZE OF A GRAIN OF RICE) OF CEMENT LEAKED INTO THE FEMORAL HEAD. SINCE THE GUIDE PIN AND BLADE DID NOT PERFORATE, A POSSIBLE CAUSE OF CEMENT LEAKAGE IN THIS SITUATION WAS THAT THE PERFORATION HAD OCCURRED DURING INSERTION OF THE HANSSON PINLOC IN THE INITIAL SURGERY. PREOPERATIVE X-RAYS DID NOT REVEAL ANY PERFORATION OF THE HANSSON PINLOC, AND IT WAS UNCLEAR WHY THE CEMENT LEAKED INTO THE FEMORAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO COMPLAINTS FROM THE SURGEON ABOUT THE PRODUCTS. THE PATIENT HAS NO MEDICAL HISTORY, MEDICA

  Patient problems: Insufficient Information

  MAUDE report 23404959 ↗
• MalfunctionJul 25, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2025 , THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE CEMENT. THE SURGEON PLACED THE AMPOULE INTO THE CARTRIDGE AND MIXED IT AS INSTRUCTED, BUT WHEN THE SURGEON TRIED TO FILL THE CEMENT INTO THE SYRINGE, NO CEMENT CAME OUT. AS A RESULT, THE SURGEON WAS UNABLE TO INSERT THE CEMENT, ALTHOUGH IT WAS MIXED SUFFICIENTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612717 ↗
• MalfunctionJul 25, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE CEMENT. THE SURGEON PLACED THE AMPOULE INTO THE CARTRIDGE AND MIXED IT AS INSTRUCTED, BUT WHEN THE SURGEON TRIED TO FILL THE CEMENT INTO THE SYRINGE, NO CEMENT CAME OUT. AS A RESULT, THE SURGEON WAS UNABLE TO INSERT THE CEMENT, ALTHOUGH IT WAS MIXED SUFFICIENTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612615 ↗
• MalfunctionJul 25, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE CEMENT. THE SURGEON PLACED THE AMPOULE INTO THE CARTRIDGE AND MIXED IT AS INSTRUCTED, BUT WHEN THE SURGEON TRIED TO FILL THE CEMENT INTO THE SYRINGE, NO CEMENT CAME OUT. AS A RESULT, THE SURGEON WAS UNABLE TO INSERT THE CEMENT, ALTHOUGH IT WAS MIXED SUFFICIENTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612581 ↗
• MalfunctionJul 25, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE CEMENT. THE SURGEON PLACED THE AMPOULE INTO THE CARTRIDGE AND MIXED IT AS INSTRUCTED, BUT WHEN THE SURGEON TRIED TO FILL THE CEMENT INTO THE SYRINGE, NO CEMENT CAME OUT. AS A RESULT, THE SURGEON WAS UNABLE TO INSERT THE CEMENT, ALTHOUGH IT WAS MIXED SUFFICIENTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612556 ↗
• MalfunctionJul 8, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING THE PROCESS OF PACKAGING THE CEMENT IN THE SYRINGES, IT WAS EVIDENT THAT IT DID NOT FLOW THROUGH THE PLUNGER. INITIALLY, THE POSSIBILITY THAT THE CEMENT HAD BEEN SET WAS CONSIDERED; HOWEVER, AFTER A REVIEW CARRIED OUT JOINTLY WITH THE SPECIALIST, IT WAS CONFIRMED THAT THE MATERIAL DID NOT SHOW ANY SIGNS OF SETTING. IT WAS IDENTIFIED THAT THE FAULT IS IN THE MECHANISM OF THE LEVER, WHICH DOES NOT OPERATE CORRECTLY AND REMAINS IN THE LOWER POSITION, PREVENTING THE CEMENT FROM BEING DRIVEN AND, THEREFORE, THAT THE SYRINGES ARE NOT FILLED PROPERLY. THEY ARE SHIPPED IN RED BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437729 ↗
• MalfunctionJul 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH CEMENT. IN THE SURGERY, THE SURGEON OPENED THE WOUND FROM THE AP SIDE AND PERFORMED REDUCTION USING THE ELEVATOR TO SUBTYPE N. AFTER CEMENT INJECTION, THE CEMENT LEAKED FROM THE FRACTURE SITE. UPON CHECKING, IT WAS CONFIRMED THAT THERE WAS CEMENT LEAKAGE FROM THE FRACTURE AREA THAT WAS REDUCED USING THE ELEVATOR. SOME OF THE LEAKED CEMENT WAS REMOVED, BUT SOME REMAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393617 ↗
• MalfunctionJul 2, 2025Migration or Expulsion of Device; Chemical Problem; Migration or Expulsion of Device; Chemical Problem

  ADDITIONAL INFORMATION RECEIVED STATES THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22390986 ↗
• MalfunctionJun 23, 2025Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESES SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE CEMENT AND THE SYRINGE. THE SURGERY STAFF MIXED THE CEMENT AND LOADED INTO TWO SYRINGES (2ML). HOWEVER, FROM THE STAFF TRIED TO LOAD INTO THE NEXT SYRINGE (1ML), IT GOT HARD TO TURN THE BLUE HANDLE. THE SURGEON ALSO TRIED TO LOAD IT BUT IT DIDN'T WORK. THE SURGEON OPENED THE NEW CEMENT AND SYRINGE, SO THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306142 ↗
• MalfunctionJun 4, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD A ORIF FOR A HIP FRACTURE WITH A TFNA CONSTRUCT, DURING THE TFNA CASE THE OPERATING SURGEON ELECTED TO UTILIZE TRAUMACEM V+ FOR THIS PARTICULAR PATIENT. DURING NORMAL MIXING PROCEDURES FOR THE CEMENT, THE DELIVERY/MIXING CONTAINER DID NOT DISPENSE CEMENT ONCE THE PROPER MIXING INSTRUCTIONS WERE FOLLOWED. IF THE LID WAS OPENED, THE CEMENT WAS SUFFICIENTLY MIXED AND DISPLAYED THE RIGHT CONSISTENCY WHEN HANDLED. DESPITE THE CORRECT CONSISTENCY, THE CEMENT WAS UNABLE TO BE INJECTED INTO THE PROPER SYRINGES FOR IMPLANTATION THROUGH THE STOP-COCK DEVICE, AND THUS A 2ND CEMENT PACKAGE AND SYRINGE KIT WERE OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140046 ↗
• MalfunctionMay 13, 2025Chemical Problem; Failure to Eject; Chemical Problem; Failure to Eject

  IT WAS REPORTED THAT ON APRIL 14, 2025, THE CEMENT HARDENED QUICKLY AND COULD NOT BE INJECTED INTO THE SYRINGE. THE CEMENT WAS KEPT IN THE REFRIGERATOR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009310 ↗
• MalfunctionMay 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978231 ↗
• MalfunctionJul 25, 2024Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THAT ON JULY 2, 2024, THE PATIENT UNDERWENT AN ORIF SURGERY TREATING THE FEMORAL TROCHANTERIC REGION. THE CEMENT WAS MIXED ACCORDING TO THE SURGICAL TECHNIQUE AND INJECTED INTO SYRINGES. HOWEVER, ALMOST NO CEMENT WAS INJECTED INTO THE 4TH BLUE SYRINGE. THE SALES REP INFORMED THE SURGEON THAT IT WAS POSSIBLE TO INJECT CEMENT INTO 4TH BLUE SYRINGE BY USING A PUSH STICK IF NEEDED. THE SURGEON DETERMINED THAT THE USE OF CEMENT IN 3 BLUE SYRINGES WAS SUFFICIENT FOR THIS CASE, AND THE OPERATION WAS COMPLETED WITHOUT PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) TRAUMACEM(TM) V+ INJECTABLE CEMENT -S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833783 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN TYPE OF INFECTION WAS CONFIRMED. THE INITIAL IMPLANTATION OCCURRED ON (B)(6) 2023. ON (B)(6) 2024, AN APPOINTMENT FOR A REMOVAL OF A TFNA IMPLANT WAS SCHEDULED. PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18841184 ↗
• MalfunctionFeb 12, 2024Entrapment of Device; Migration or Expulsion of Device; Entrapment of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH A COMPETITOR¿S SHORT NAIL FOR A FEMORAL TROCHANTERIC FRACTURE. AFTER THE SURGERY, A SECONDARY FRACTURE OCCURRED, AND A REVISION SURGERY WITH A CERCLAGE CABLE, TFNA LONG NAIL, AND CEMENT WAS PERFORMED ON (B)(6) 2024. DURING THE REVISION SURGERY, AFTER ALL THE FIXATION PROCEDURES WERE COMPLETED, A FINAL CHECK WITH AN IMAGE INTENSIFIER REVEALED CEMENT LEAKAGE INTO THE SOFT TISSUE NEAR THE CALCAR IN THE JOINT AND ABOVE THE END CAP. THE CEMENT ABOVE THE END CAP WAS REMOVED, BUT THE CEMENT NEAR THE CALCAR WAS NOT REMOVED AT THE SURGEON¿S DISCRETION, AND THE PATIENT WAS TO BE MONITORED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. CEMENT INJECTION WAS STARTED WHILE VIEWING THE FRONTAL IMAGE WITH AN IMAGE INTENSIFIER, AND AT THAT TIME THERE WAS NO SIGN OF CEMENT LEAKING INTO THE CALCAR. FROM THE TIME OF INJECTION OF THE CEMENT IN THE 3RD BLUE SYRINGE, THE CEMENT WAS INJECTED WHILE CHECKING WITH THE AXIAL VIEW, AT WHICH POINT THERE WAS NO SIGN OF CEMENT LEAKAGE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TRAUMACEM(TM)

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686246 ↗
• MalfunctionJan 18, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE AUGMENTING INTO THE FEMORAL HEAD DURING A PROCEDURE USING TFNA, THE CEMENT WAS NOT PUSHING THROUGH THE CANNULA INTO THE HELICAL BLADE. ALL STEPS TO MIX AND PREPARE AUGMENT WERE FOLLOWED BY TECHNIQUE, AS WELL AS PROPER INSERTION DONE BY THE SURGEON. THE PROCEDURE STILL WAS COMPLETED SUCCESSFULLY, BUT THE STERILE BOX TRAUMACEM WERE ALL WASTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) TRAUMACEM(TM) V+ INJECTABLE CEMENT -S * THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534044 ↗
• MalfunctionJan 12, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR FRACTURES OF FEMORAL TROCHANTER. THE CEMENT AUGMENTATION WAS PERFORMED DURING THE SURGERY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023, THE SURGEON COMMENTED THAT A LITTLE CEMENT LEAKED FROM THE BLADE INSERTION AREA. THE DOCTOR DID NOT NOTICE IT ON X-RAYS DURING THE OPERATION, BUT THE DEVICES MAY HAVE CAUGHT ON THE FASCIA WHEN HE PULLED OUT THE INJECTION CANNULA, CAUSING THE CEMENT TO LEAK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18505159 ↗
• MalfunctionNov 30, 2023Chemical Problem; Failure to Eject; Chemical Problem; Failure to Eject

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. WHILE FILLING A SYRINGE WITH CEMENT, THE SURGEON UNINTENTIONALLY PUSHED UP THE MIXER VALVE A LITTLE. THE SURGEON RETURNED THE VALVE AND TURNED THE HANDLE CLOCKWISE, BUT THE VALVE INSIDE THE MIXER BECAME STIFF AND THE SURGEON WAS UNABLE TO FILL THE SYRINGE WITH CEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239659 ↗
• MalfunctionAug 9, 2023Chemical Problem; Failure to Eject; Chemical Problem; Failure to Eject

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR FEMORAL TROCHANTERIC FRACTURE. CEMENT WAS MIXED AT THE TIME OF BLADE INSERTION, HOWEVER THE CEMENT FELT HARDER THAN ANTICIPATED AND THE AMOUNT COMING OUT OF THE BLADE WAS SMALL. DESPITE THIS, CEMENT WAS INJECTED INTO 2 CANNULAS AND INTO THE BLADE. HOWEVER, WHEN INJECTING INTO ADDITIONAL SYRINGES THE CEMENT HAD BECOME TOO HARD AND COULD NOT BE INJECTED. THE REMAINING SYRINGES HAD BECOME QUITE HOT AND HAD HARDENED EXCESSIVELY. IT WAS CONFIRMED THAT THERE WAS NO ISSUE WITH THE PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH UNDER 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487833 ↗
• MalfunctionAug 8, 2023Migration or Expulsion of Device; Failure to Eject; Migration or Expulsion of Device; Failure to Eject

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE. THE SURGEON OPENED THE CEMENT KIT IN QUESTION BUT THE CEMENT WOULD NOT COME OUT FROM THE STOP-COCK SMOOTHLY. THE SURGEON THOUGHT THERE MIGHT BE A PROBLEM AT THE STOP-COCK AND REPLACED IT WITH A 3-WAY STOP-COCK, HOWEVER CEMENT LEAKED OUT WHEN THE STOP-COCK WAS REMOVED. THE CEMENT HAD NOT HARDENED SO IT WAS INJECTED INTO MULTIPLE SYRINGES. WHEN THE SURGEON INJECTED CEMENT INTO THE PATIENT, IT WAS HARDENING AND TOOK LONGER THAN ANTICIPATED. LESS THAN 2 ML OF CEMENT WAS INJECTED INTO THE BONE HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES OF DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480691 ↗