INSTRUMENT 2101-0200Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327211511), received between Jun 19, 2017 and Jun 10, 2024 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Fracture; Device Difficult to Setup or Prepare; Fracture; Device Difficult to Setup or Prepare

  "INSTRUMENT BROKE DOWN DURING SURGERY. REPLACEMENT DEVICE WAS USED TO COMPLETE THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498049 ↗
• MalfunctionMar 28, 2024Device Difficult to Setup or Prepare; Inadequacy of Device Shape and/or Size; Device Difficult to Setup or Prepare; Inadequacy of Device Shape and/or Size

  "THE THREAD IS TOO LONG... POPS OUT OF THE IMPACTOR... NEW IMPACTOR IN ANOTHER KIT WAS OPENED, DELAY APPROX. 5 MIN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997566 ↗
• MalfunctionFeb 15, 2024Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  AS REPORTED BY REP: "TRIDENT CUP INTRODUCER THREADS TOO LONG. NEVER NOTICED BEFORE AS NORMALLY USE MAKO INTRODUCER. HAVE THE THREADS LENGTHENED THROUGH USE OR IS THIS A PROBLEM WITH LOT? INTRODUCER HANDLE THREADS PROTRUDING THROUGH WINDOW TRIAL AND DEFINITIVE SHELL. THEY ARE TOO LONG. SURGEON HAD LESS THREAD INSIDE ACETABULAR CUP AND HAD TO USE FINAL CUP IMPACTOR TOO." CASE: LEFT THA MANUAL CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710757 ↗
• MalfunctionSep 6, 2023Degraded; Degraded

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE THREADS OF THE IMPACTOR/ POSITIONER ARE WEARING OUT AND RISK CROSS-THREADING SHELLS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691625 ↗
• MalfunctionApr 27, 2023Fracture; Fracture

  THE TRIDENT IMPACTION HANDLE BROKE DURING THE IMPACTION OF A TRIDENT WINDOW TRIAL DURING SURGERY. THE WINDOW TRIAL GOT STUCK AND VERY DIFFICULT TO GET OUT AND GOT DEFORMED. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16821811 ↗
• MalfunctionDec 14, 2022Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT DURING IMPACTION, THE HANDLE BROKE APPROXIMATELY 1 INCH FORWARD OF THE IMPACTION SURFACE. NOTHING FELL INTO THE PATIENT AND ALL PIECES WERE REMOVED. A SECOND INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 TO 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974991 ↗
• MalfunctionSep 9, 2021Fracture; Fracture

  DURING TRIAL PHASE OF THE OPERATION, THE TRIAL ITSELF WAS BROKEN THE HEAD PART OF THE HOLDER WAS BROKEN DURING NAILING OF ACETABULAR SHELL TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446043 ↗
• MalfunctionFeb 12, 2020Fracture; Material Deformation; Fracture; Material Deformation

  OUR COMPANY REPRESENTATIVE REPORTED THAT" THE GROOVE PORTION OF THE PRODUCT IS BROKEN. THE PROBLEM OF THE PRODUCT WAS NOTICED AFTER THE PATIENT WAS APPLIED."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9702561 ↗
• InjuryDec 10, 2019Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  DURING INSERTING THE ITEM IT BROKE. THE IMPACTOR HAS DAMAGED THE ACETABULUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY INSERTING THE PRIMARY TRIDENT CUP AS PLANNED.

  Patient problems: Hip Fracture; No Known Impact Or Consequence To Patient

  MAUDE report 9444235 ↗
• MalfunctionNov 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY HIP PROCEDURE. REP REPORTED THAT DUE TO METAL SPURS ON THE THREADS OF THE INSERTER, THE INSTRUMENT WOULD NOT THREAD INTO THE SHELL. A SECOND DEVICE WAS IMMEDIATELY AVAILABLE IN THE O.R. AND WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN, AND THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9343405 ↗
• MalfunctionOct 28, 2019Break; Fracture; Break; Fracture

  AFTER THE CASE, IT WAS NOTICED THAT THE CUP IMPACTOR WAS STRIPPED. NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9244164 ↗
• MalfunctionOct 21, 2019Loss of or Failure to Bond; Mechanical Problem; Loss of or Failure to Bond; Mechanical Problem

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF HOSPITAL INVENTORY, THE JUNCTION OF THE METAL ROD AND THE HANDLE OF THE CUP INSERTER WAS LOOSE. NO ASSOCIATED PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9214835 ↗
• MalfunctionAug 29, 2019Material Integrity Problem; Material Integrity Problem

  PRIMARY HIP PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS USING THE SHELL INSERTER TO REPOSITION THE SHELL INTRA-OPERATIVELY. THE SHELL WAS IMPLANTED. POST-SURGICAL INSPECTION REVEALED THAT THE THREADS OF THE INSERTER WERE DAMAGED. SURGERY HAD BEEN COMPLETED SUCCESSFULLY WITH NO DELAY. THE DEVICE IS AVAILABLE FOR RETURN, AND THE REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8946457 ↗
• InjuryAug 14, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  PRIMARY PROCEDURE, RIGHT THA. IT WAS REPORTED THAT DURING IMPACTION, THE WINDOW TRIAL DISENGAGE FROM THE IMPACTION HANDLE AND WAS IMPACTED THROUGH THE ACETABULUM. THE TRIAL WAS FOUND AND REMOVED FROM THE PATIENT. SUBSEQUENT TRIALS STAYED ENGAGED TO THE HANDLE AS INTENDED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 30 MINUTES. THE REP REPORTED THAT THE DEVICE MAY BE AVAILABLE FOR RETURN, AND THAT HE MAY BE ABLE TO OBTAIN INTRA-OPERATIVE X-RAYS AND THE OPERATIVE REPORT, BUT DOES NOT HAVE ACCESS TO ANY ADDITIONAL INFORMATION.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8892500 ↗
• MalfunctionJun 5, 2019Crack; Fracture; Crack; Fracture

  AS REPORTED: "RESETTING INSTRUMENTS IN CENTRAL STERILE AFTER PROCEDURE AND NOTICED HANDLE ON IMPACTOR WAS CRACKED. COMPLAINT NOT [NOTICED] IN PROCEDURE".

  Patient problems: No Patient Involvement

  MAUDE report 8670466 ↗
• MalfunctionMay 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WHEN CUP INSERTER HAS BEEN WASHED IT SEEMS LIKE SOMETHING IS COMING OUT FROM THE THREAD. IT IS NOT KNOWN IF IT IS METAL DEBRIS OR BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 8654575 ↗
• MalfunctionMay 30, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WHEN CUP INSERTER HAS BEEN WASHE IT SEEMS LIKE SOMETHING IS COMING OUT FROM THE THREAD.. IT IS NOT KNOWN IF IT IS METAL DEBRIS OR BLOOD.

  Patient problems: No Patient Involvement

  MAUDE report 8654057 ↗
• MalfunctionFeb 26, 2019Break; Break

  HAVE RECEIVED A 2101-0200 FROM CUSTOMER. THEY DONT KNOW WHEN PRODUCT BROKE. DISCOVERED IN STERILE DEPARTMENT. IT¿S BEEN FORGOTTEN IN A BOX. HAS NOT BEEN USED IN SURGERY SINCE DISCOVERED DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 8372143 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT THE PRODUCT WITH A REF NUMBER 2101 0200 WAS BROKEN DURING SURGERY. THE BACKUP PRODUCT WAS USED INSTEAD OF BROKEN ONE DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257850 ↗
• MalfunctionDec 11, 2018Mechanical Problem; Mechanical Problem

  THREADED THE TRIDENT 54 TRIAL ONTO THE ACETBAULAR WHITTIER IMPACTOR THREADED PIECE WAS SCREWING PAST THE CUP TRIAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152529 ↗
• InjuryNov 30, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE THREADS AT THE END OF THE INSERTION HANDLE PROTRUDED TOO FAR FROM THE TRIAL AND FROM THE SHELL AND THUS DAMAGED THE FLOOR OF THE ACETABULUM AND RESULTED IN A DIFFICULT PLACEMENT OF CUP. THE HANDLE WAS EXAMINED AFTER THE PROCEDURE WHEN THE PATIENT WAS IN RECOVERY AND SAFE. WE FOUND THE THREADED TIP WAS LOOSE AND DEFECTIVE

  Patient problems: Injury

  MAUDE report 8120154 ↗
• MalfunctionOct 30, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  INSERTION HANDLE WOULD NOT THREAD SMOOTHLY. HANDLE TOO SLIPPERY FOR SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021376 ↗
• MalfunctionAug 15, 2018Imprecision; Imprecision

  IT WAS REPORTED THAT THE THREADED PORTION OF THE PRODUCT APPEARS TOO LONG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7786651 ↗
• MalfunctionJul 10, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  SURGEON WAS PERFORMING A DIRECT ANTERIOR TOTAL HIP. WHEN HE ATTEMPTED TO IMPACT A SIZE 52 TRIDENT II SHELL AFTER REAMING TO A 52, THE CUP WOULD NOT STICK IN PLACE, ON FLUORO IT WAS SHOWING THAT IT BOTTOMED TO WHERE HE REAMED HOWEVER. HE THEN DECIDED TO TRIAL WITH A 54 WINDOW TRIAL AND IT APPEARED TO SEAT WITHOUT FURTHER REAMING BUT IT DIDN'T HAVE "A GREAT BITE." HE THEN DECIDED TO GO WITH A 56 SHELL, BUT FIRST PUT A 55 REAMER IN AND HE DIDN'T EVEN NEED TO TURN THE REAMER ON AS IT APPEARED TO SIT IN. HE ATTEMPTED TO IMPACT THE 56 SHELL WHERE IT SEEMED TO BOTTOM OUT WITHIN A FEW MALLET STRIKES OF IMPACTION, HOWEVER WITH SUBSEQUENT STRIKES WITH THE MALLET, THE SHELL BACKED OUT A BIT VISUALIZED ON FLUORO. WE NOTICED AFTER PULLING THE SHELL OUT AND LOOKING AT FLURO WE NOTICED THE CUP INSERTER THREADS PROTRUDING SIGNIFICANTLY OUT THE BACKSIDE OF THE SHELL. SURGEON THEN DECIDED TO UNTHREADED THE SHELL ENOUGH SO THE THREADS WERE NO LONGER PROTRUDING AND THEN PROCEEDED TO SUCCESSFULLY IMPACT THE SHELL. THE AFFECTED INSERTER WAS PART NUMBER 2101-0200 LOT 133114. IT APPEARED TO HAVE 5 THREADS. WE OPENED A SECOND INSERTER (LOT 133016) WE HAD IN HOUSE AND THAT INSERTER HAD LESS THREADS (~3 LOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674718 ↗
• MalfunctionMay 10, 2018Break; Fracture; Break; Fracture

  AFTER INSPECTION AFTER DISHWASHER IT WAS DISCOVERED THAT THE THREAD IS "BROKEN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502111 ↗