NA 2598-07-470Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS COR/TRI POST STEM INSERT SHAFT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295148456), received between Sep 21, 2017 and Jul 2, 2024 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Break” (18 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.
Reports received per month
Most reported problems
Device problems
- Break18
- Entrapment of Device4
- Device-Device Incompatibility3
- Fracture1
Patient problems
- No Consequences Or Impact To Patient12
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- No Information3
- Not Applicable1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2024Break; Break
IT WAS REPORTED THAT THE NIPPLE ON THE IMPACTOR TIP FOR STEM BROKE OFF WHILE IMPLANTING STEM.
Patient problems: Insufficient Information
MAUDE report 19654320 ↗MalfunctionMar 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRILOCK INSERTION INSTRUMENT STICKS TO THE STEM, AND IT WAS DIFFICULT TO REMOVE AFTER IMPLANTATION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16485058 ↗MalfunctionFeb 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE UNIVERSAL INSERTER HANDLE AND THE CORAL/TRI-LOCK WERE STUCK TOGETHER AND COULD NOT BE SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16417406 ↗MalfunctionJan 4, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY VIA BHA. IN THE SURGERY, THE HANDLE IN QUESTION AND THE SHAFT IN QUESTION REMAINED ENGAGED AND COULD NOT BE REMOVED, MAKING REPLACEMENT IMPOSSIBLE. AFTER HAMMERING SEVERAL TIMES, WHEN THE SURGEON TRIED TO REPLACE THE SHAFT, IT DID NOT COME OFF. THE INSTRUMENTS WERE INSPECTED BEFORE PREOPERATIVE STERILIZATION, AND THEY WERE EASY TO ATTACH AND DETACH AT THAT TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16094056 ↗MalfunctionJul 19, 2022Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE AND STAYED IN STEM. THERE WAS JUST ONE PIECE THAT BROKE OFF AND IT FELL INTO THE IMPLANT SHOULDER AND OUT OF VIEW. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15051257 ↗MalfunctionDec 14, 2021Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT DURING INSERTION OF A CORAIL STEM, THE TIP OF THE INSERTER SHAFT BROKE OFF. THE BROKEN PIECE WAS NEVER FOUND BUT THE JOINT WAS SEARCHED THOROUGHLY PRIOR TO CLOSING. NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 13003351 ↗MalfunctionApr 2, 2020Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE POSTERIOR CORIAL STEM INSERTER BROKE INTO TWO PIECES. THE SMALL TIP BROKE OFF WHILE IN USE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9918170 ↗MalfunctionApr 2, 2020Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE CORAIL INSERTER SHAFT BROKE INTO TWO PIECES. THE SMALL TIP BROKE OFF DURING THE CASE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9918121 ↗MalfunctionSep 18, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF TRI-LOCK STEM INSERTER BROKE OFF IN THE STEM WHILE IMPACTING. THE TIP OF THE INSERTER GOT STUCK IN THE STEM. SURGEON REMOVED THE STEM AND IMPLANTED A DIFFERENT ONE BECAUSE HE COULDN¿T REMOVE THE BROKEN TIP. THERE WAS 20 MINUTES SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 9081730 ↗MalfunctionJul 29, 2019Break; Break
BROKEN INSTRUMENTS WERE IN DESIGNATED BOX AT FACILITY LABELED AS "BROKEN" OR WERE FOUND IN STERILE WRAPPED SETS THAT WERE RETURNED TO THE OFFICE. NO PATIENT WAS AFFECTED. NO SURGERY WAS AFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8837634 ↗MalfunctionMay 28, 2019Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING IMPACTION OF THE STEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8646807 ↗MalfunctionMar 29, 2019Break; Break
THE TIP OF THE IMPACTOR IS BROKEN. THE PART THAT GOES IN THE IMPLANT FOR IMPACTION IS NOT THERE ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8465495 ↗MalfunctionFeb 11, 2019Break; Break
IT WAS REPORTED THAT THE STEM INSERTED BROKE. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8325808 ↗MalfunctionJan 28, 2019Break; Break
THE IMPACTOR TIP WAS BROKEN UPON IMPACTION OF FEMORAL STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8281380 ↗MalfunctionDec 12, 2018Break; Break
IT WAS REPORTED THAT THE INTRUMENT'S TIP WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8156897 ↗MalfunctionOct 29, 2018Break; Break
IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF WHILE INSERTING TRILOCK STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8014352 ↗MalfunctionAug 23, 2018Break; Break
IT WAS REPORTED THAT THE INSERTER TIP CHIPPED OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7809576 ↗MalfunctionJan 12, 2018Fracture; Fracture
IT WAS REPORTED THAT THE BACK OF INSERTER BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7185466 ↗MalfunctionJan 5, 2018Break; Break
IT WAS REPORTED THAT THE STEM INSERTER TIP BROKE OFF WHILE INSERTING THE FULL FEMORAL IMPLANT. NO SURGICAL DELAY. NO PIECES OF BROKEN INSTRUMENTATION LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7168505 ↗MalfunctionNov 8, 2017Break; Break
IT WAS REPORTED THAT THE TIP BROKE OFF UPON IMPACT.
Patient problems: No Information
MAUDE report 7011739 ↗MalfunctionOct 5, 2017Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN DURING INSPECTION. UPDATE 9/8/2017:ADDITIONAL INFORMATION RECEIVED FOR THE FOLLOWING; THE TIP THAT ATTACHES TO THE IMPLANT WAS BROKEN OFF.
Patient problems: No Information
MAUDE report 6918128 ↗MalfunctionSep 21, 2017Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP WAS BROKEN.
Patient problems: No Information
MAUDE report 6883749 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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