NexGen® 00-5901-020-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00889024201620), received between Oct 17, 2019 and Feb 23, 2026 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Fracture; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT THE DOCTOR ASSEMBLED THE TIBIAL JIG AND WERE ABOUT TO PIN IT IN POSITION WHEN THE PIN JAMMED IN THE JIG AND THEN SNAPPED. THE PIN WOULD NOT COME OUT DESPITE A HANDFUL OF PEOPLE TRYING TO REMOVE IT, SO AS A RESULT, A PLUS 2MM SLOTTED TIBIAL CUT GUIDE WAS USED. IT IS BELIEVED THAT THE PIN HAD A SLIGHT BEND AND THAT RESULTED IN IT GETTING JAMMED & ULTIMATELY SNAP. THERE WAS NO PATIENT IMPACT, NO SURGICAL DELAY, NO PIECE'S FALL INTO THE PATIENT. DUE TO THIS THE DOCTOR HAD TO RECUT THE TIBIA TWICE, AS THE FIRST CUT WAS 2MM TO SHORT. LATER ON, THE TIBIAL RESECTION WAS STILL SLIGHTLY UNDERCUT, AND THE DOCTOR HAD TO USE THE RASPS TO GET THE CORRECT AMOUNT OF SPACE FOR THE 8MM POLY. IN THE END THE SURGERY OUTCOME WAS SUCCESSFUL, AND THE DOCTOR WAS HAPPY WITH THE FINAL POSITIONING OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413403 ↗
• InjuryDec 22, 2025Fracture; Material Twisted/Bent; Mechanical Jam; Fracture; Material Twisted/Bent; Mechanical Jam

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862694 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719736 ↗
• MalfunctionNov 6, 2025Fracture; Fracture

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486224 ↗
• MalfunctionAug 20, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851099 ↗
• MalfunctionJul 17, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE PIN GOT STUCK IN THE CUTTING BLOCK HOLE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531870 ↗
• MalfunctionJun 13, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT WHILE INSERTING THE CENTER PIN INTO THE FEMUR AND FIXING THE CUTTING BLOCK, THE SURGEON ATTEMPTED TO INSERT THE SMOOTH PIN MEDIALLY. HOWEVER, THE PIN DID NOT GO IN PROPERLY AND BROKE OFF. THE BROKEN PIN CONNECTION WAS LEFT IN THE PIN ATTACHMENT. THERE WAS A 5-10 MINUTE SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. NO PIECES FELL INTO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202605 ↗
• MalfunctionApr 28, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923476 ↗
• MalfunctionNov 27, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE BASE OF HEADLESS TROCAR DRILL PIN WAS NOT MACHINED INTO A HEXAGONAL SHAPE. IT WAS NOT POSSIBLE TO DETERMINE WHICH OF THE TWO LOT NUMBERS WAS APPLICABLE. THERE WAS A 16-30 MINUTE SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAD BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793755 ↗
• MalfunctionNov 27, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE BASE OF HEADLESS TROCAR DRILL PIN WAS NOT MACHINED INTO A HEXAGONAL SHAPE. IT WAS NOT POSSIBLE TO DETERMINE WHICH OF THE TWO LOT NUMBERS WAS APPLICABLE. THERE WAS A 16-30 MINUTE SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAD BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792994 ↗
• MalfunctionOct 10, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417930 ↗
• MalfunctionSep 10, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON NOTED DEBRIS IN THE STERILE PACKAGING OF A DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184690 ↗
• MalfunctionAug 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN TRYING TO REMOVE THE PIN FROM THE CUT GUIDE, IT GOT STUCK AND COULD NOT BE REMOVED. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041552 ↗
• MalfunctionMay 14, 2024Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT THE PIN COLD WELDED WHEN BEING REMOVED FROM THE GUIDE AND SNAPPED OFF IN THE BLOCK. THERE WAS NO HARM OR EFFECT ON THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308696 ↗
• MalfunctionApr 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE PROCEDURE, A HEADLESS PIN BECAME STUCK IN THE CUT GUIDE AND SUBSEQUENTLY FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173921 ↗
• MalfunctionApr 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE CUT GUIDE SEIZED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142894 ↗
• InjuryApr 4, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19045246 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, A TROCAR DRILL PIN BROKE OFF IN THE CUT BLOCK. THE FOLLOWING DAY, THE PIN WAS REMOVED FROM THE BLOCK SO THE BLOCK COULD CONTINUE TO BE USED. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646238 ↗
• MalfunctionAug 9, 2023Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492542 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, PATIENT DEVELOPED A PSEUDOANEURYSM. THE SURGEON BELIEVES THE ARTERY BELOW THE KNEE WAS PUNCTURED BY A TROCAR PIN DURING INSERTION INTO THE CUT GUIDE AS PART OF THE KNEE ARTHROPLASTY. A PROCEDURE TO CORRECT THE PSEUDOANEURYSM WAS PERFORMED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pseudoaneurysm

  MAUDE report 17470211 ↗
• MalfunctionJul 26, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397541 ↗
• MalfunctionFeb 7, 2023Fracture; Material Fragmentation; Mechanical Jam; Fracture; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT WHEN FIXING THE RELEVANT TIBIAL CUTTING BLOCK WITH THE PIN, METAL DEBRIS FORMED. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. THE SURGERY WAS NOT COMPLETED WITH A SECOND DEVICE. THE METAL DEBRIS DID FALL INTO THE PATIENT AND STAFF WERE NOT SURE IF ALL OF THE PIECES HAD BEEN RETRIEVED. NO POST-OP IMAGING WAS TAKEN TO CONFIRM IF METAL DEBRIS WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16310915 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950681 ↗
• InjuryDec 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PIN WAS PLACED BY THE SURGEON AND WHEN HE WENT TO REMOVE IT, IT FELL OUT. THE TEAM WAS UNABLE TO LOCATE THE PIN ON THE STERILE FIELD AT THAT TIME AND THOUGHT IT MAY HAVE FALLEN BY THE LEG POSITIONING PLATE. THE SURGEON WAS CONFIDENT THAT IT WAS NOT IN THE PATIENT. DURING CLOSURE, THE TECH ASKED THE TEAM IF THEY WERE ABLE TO LOCATE THE PIN AND TOLD THEM THEY WOULD NEED TO FIND IT BEFORE THE END OF THE CASE. THE SURGEON WAS STILL CONFIDENT THAT IT WAS NOT IN THE PATIENT. THE ROOM WAS SEARCHED AND FOUND THE PIN ON THE FLOOR. WHEN THEY INSPECTED IT, THEY FOUND THAT HALF OF IT WAS BROKEN OFF. THEY ESCALATED HER CONCERN TO THE PA AND SURGEON. AN X-RAY WAS TAKEN AND THE BROKEN PIECE WAS VISUALIZED IN THE TIBIA. IT BROKE OFF FAR ENOUGH INTO THE BONE THAT IT COULD NOT BE SEEN WITHOUT X-RAY AND WOULD CAUSE MORE PATIENT HARM IF IT WAS REMOVED. THE SURGEON LEFT THE BROKEN PIECE OF THE PIN IN PLACE AND PATIENT WAS TRANSPORTED TO PACU. WHILE IT WOULD HAVE BEEN HELPFUL TO FIND THE MISSING PIECE OF THE PIN THAT BROKE OFF IN THE BONE SOONER, IT WOULD NOT HAVE CHANGED THE TREATMENT FOR THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15904447 ↗
• MalfunctionJun 22, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PIN WELDED TO THE DEVICE AND COULD NOT BE REMOVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777693 ↗