TRI-LOCK 2012-03-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295082095), received between Mar 20, 2018 and Jan 27, 2023 — classified as 1 injury, 21 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT NOTHING BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251833 ↗
• 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 10235550 ↗
• InjuryMay 28, 2020Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE SZ 4 BROACH AFTER TRIALING, THE RETAINING PIN ON THE TOP OF THE BROACH BROKE. THE SURGERY WAS EXTENDED IN ORDER TO PERFORM AN OSTEOTOMY TO RETRIEVE THE BROACH FROM THE PROXIMAL FEMUR WITH MULTIPLE VICE GRIPS AND A SLAP HAMMER. THE PROXIMAL FEMUR REQUIRED 1 ORTHO CABLE. ALL PIECES WERE REMOVED FROM THE WOUND AND LIKELY THE BROACH WAS FATIGUED. SURGICAL DELAY OF 25-30 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10097849 ↗
• MalfunctionOct 14, 2019Device-Device Incompatibility; Scratched Material; Physical Resistance/Sticking; Device-Device Incompatibility; Scratched Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SIZE 4 TRILOCK BROACH GETS STUCK ONTO THE BROACH ADAPTER AND CANNOT EASILY BE REMOVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188865 ↗
• MalfunctionAug 20, 2019Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE TRI-LOCK BROACH SIZE 4 (P/N: UNKNOWN) AND THE BROACH HANDLE WERE NOT ABLE TO CONNECT DURING THE THA SURGERY ON (B)(6) 2019. AS A RESULT OF CONFIRMING, THE BROACH HANDLE WAS ABLE TO CONNECT WITH OTHER ALL BROACHES, SO THERE WAS A POSSIBILITY OF THE BROACH IN QUESTION HAD BEEN DISTORTED OR HAD BEEN SCRATCHED. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912173 ↗
• 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 7671371 ↗
• 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 7671367 ↗
• 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 7671342 ↗
• 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 7671271 ↗
• 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 7671130 ↗
• MalfunctionJun 8, 2018Break; Break

  IT WAS REPORTED THAT THE SIZE 4 TRI-LOCK BROACH BROKE WHILE DRILLING THE FEMUR. NO DELAY AS OTHER SIZES WERE USED. IT WAS ALSO REPORTED THAT THE 25MM ACETABULAR DRILL BITS BROKE 10-15MM DISTAL OF THE TIP.NONE OF THE PIECES WERE LEFT IN THE PATIENT. A NEW DRILL BIT WAS USED EACH TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7582102 ↗
• MalfunctionApr 27, 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 7469097 ↗
• MalfunctionApr 27, 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 FROM 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 7469074 ↗
• 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 7443183 ↗
• 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 7442819 ↗
• 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 7442613 ↗
• MalfunctionApr 17, 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 7437903 ↗
• MalfunctionApr 17, 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 7437897 ↗
• MalfunctionMar 20, 2018Scratched Material; Scratched Material

  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. SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353171 ↗
• MalfunctionMar 20, 2018Scratched Material; Scratched Material

  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. SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353152 ↗
• MalfunctionMar 20, 2018Scratched Material; Scratched Material

  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. SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353133 ↗
• MalfunctionMar 20, 2018Scratched Material; Scratched Material

  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. SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353097 ↗