TRI-LOCK 2012-03-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295082101), received between Nov 21, 2017 and Dec 2, 2022 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Break; Break

  ADDITIONAL INFORMATION STATED THAT A SMALL RESECTION OF BONE WAS PERFORMED REVEALING THE TEETH OF THE BROACH AND POUNDED OUT WITH A TAMP.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15906556 ↗
• MalfunctionOct 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH IS STICKING TO THE KINCISE ADAPTERS AS WELL AS THE BROACH HANDLES. IT WAS DISCOVERED WHILE PUTTING INSTRUMENTS TOGETHER. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639392 ↗
• MalfunctionAug 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE BROACHING THE FEMUR WITH THE KINCISE THE SIZE 5 TRILOCK BROACH GOT STUCK TO THE ANTERIOR BROACH ADAPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198307 ↗
• MalfunctionMay 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON BROACHED UP TO A 5 BROACH AND IMPLANTED A SIZE 5 TRILOCK STD. IT SAT PROUD AND AFTER REBROACHING IT STILL SAT PROUD ABOUT A CM. HE THEN REMOVED THE STEM, REBROACHING AGAIN AND WE OPENED A NEW SIZE 5 STD TRILOCK. THIS DELAYED THE CASE ABOUT 5-10 MINUTES BUT WAS NOT DETRIMENTAL TO THE OUTCOME OF THE CASE. THE OPERATIVE SIDE WAS THE RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11784357 ↗
• MalfunctionJul 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  SURGEON COMPLAINED THAT FEMORAL BROACHES WERE GETTING STUCK IN THE CANAL AND WAS CONCERNED THEY WERE OUT OF SPEC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10235580 ↗
• MalfunctionJan 31, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE SZ 5 TRILOCK BROACH, THE TRUNION OF THE BROACH BROKE WHILE IMPACTING THE BROACH HANDLE IN AN ATTEMPT TO REMOVE THE BROACH. EXTRACTION SETS WERE MADE AVAILABLE TO REMOVE THE BROKEN BROACH WITH A VICE-GRIP & SLAP HAMMER. ALL PIECES WERE RECOVERED. ANOTHER TRILOCK SET WAS AVAILABLE TO COMPLETE BROACHING & CONTINUE THE CASE. WITH 18-20 MINUTES SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 8292487 ↗
• MalfunctionAug 22, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE DOCTOR COMPLAINED THAT THE SIZE 5 BROACH AND THE SIZE 5 TRILOCK IMPLANT WERE A CM DIFFERENT IN SIZE. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7805513 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME. THE PRODUCT MANAGERS HAVE SAID WE NEED TO REPLACE THE BROACHES. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7671444 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME. THE PRODUCT MANAGERS HAVE SAID WE NEED TO REPLACE THE BROACHES. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7671436 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME. THE PRODUCT MANAGERS HAVE SAID WE NEED TO REPLACE THE BROACHES. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7671412 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THERE WAS A 5-MINUTE SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7671400 ↗
• MalfunctionJul 9, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE SIZE 4HI AND 5HI TRILOCK STEMS SIT 5-10MM ABOVE WHERE THE SURGEON INTENDS (AND SOMETIMES THE SIZE 3). HE BURIES THE BROACH UNDER THE CALCAR AND THE GRIPTION COATING ON THE STEM STILL SITS WAY ABOVE WHERE HE BURIED THE BROACH TO, EACH AND EVERY TIME. THE PRODUCT MANAGERS HAVE SAID WE NEED TO REPLACE THE BROACHES. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7671385 ↗
• MalfunctionApr 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454138 ↗
• MalfunctionApr 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454107 ↗
• MalfunctionApr 19, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7443233 ↗
• MalfunctionApr 19, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM THOMAS JEFFERSON UNIVE HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7443165 ↗
• MalfunctionApr 19, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM EACH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7443034 ↗
• MalfunctionApr 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL ( 7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442940 ↗
• MalfunctionApr 19, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DUE TO SEVERAL COMPLAINTS BY THE SURGEON, THE BROACHER FROM (B)(6) HOSPITAL (7 SETS) ARE BEING RETURNED FOR FURTHER TESTING. SIZES 0-7 FORM ECH SET WILL BE RETURNED. THE INITIAL COMPLAINTS WERE MADE REGARDING BROACH TO IMPLANT MISMATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442888 ↗
• MalfunctionApr 16, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PART OF THE BROACH THAT CONNECTS WITH THE BROACH HANDLE AND TRIAL NECK HAS BEEN DAMAGED AND MADE IT REALLY HARD TO GET THE BROACH HANDLE AND TRIAL HEAD TO GO ON AND OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7433956 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353217 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353173 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353153 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT DUE TO THE ONGOING COMPLAINTS OF THE SURGEON REGARDING BROACH TO IMPLANT MISMATCH. ALL SIZE 0-7 BROACHES WILL BE REMOVED FROM THE TRILOCK SETS FOR FURTHER TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353117 ↗
• MalfunctionNov 21, 2017Break; Break

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE TRILOCK SIZE 5 BROACH BROKE DURING CASE. THE TIP SNAPPED OFF WHERE THE BROACH HANDLE ATTACHES.

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

  MAUDE report 7048257 ↗