NA 9200-10-027Recalls & reported problems
Depuy (Ireland) · DePuy MI System IMPACTOR TIP 32mm · Class 1
Quick summary
This DePuy impactor tip is used to press hip replacement liners into place during surgery. Most of the 31 reports describe the tip breaking, sometimes in two pieces, with fragments then removed and procedures completed. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295221876), received between Sep 22, 2017 and Aug 7, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Break” (30 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.
Reports received per month
Most reported problems
Device problems
- Break30
- Device-Device Incompatibility1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient10
- Insufficient Information4
- No Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174413 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT IMPACTOR TIP 32MM BROKE INTO TWO PIECES AND NEEDS TO BE REPLACED. ALL PIECES WERE RETRIEVED. NO DELAY OR ADVERSE EVENT WAS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774906 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING LINER IMPACTION. THE FRAGMENT WAS REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 21710582 ↗MalfunctionMar 12, 2025Break; Break
IT WAS REPORTED THAT THE BOTTOM OF IMPACTION TIP SNAPPED OFF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21583942 ↗MalfunctionApr 22, 2024Break; Break
LINER IMPACTOR TIP BROKE WHILE USING IT TO IMPACT A 32MM LINER INTO THE ACETABULAR SHELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159560 ↗MalfunctionApr 1, 2024Break; Break
IT WAS REPORTED THAT THE CONSIGNMENT TRAY WAS DAMAGED IT HAD A CRACK IN IT. 32MM IMPACTOR TIP 920010027 FROM OPTIMUS INSTRUMENT TRAY (B)(6) BROKE AS WAS IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011487 ↗MalfunctionNov 28, 2023Break; Break
IT WAS REPORTED THAT THE 32MM LINER IMPACTOR TIP IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18217038 ↗MalfunctionAug 23, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING HIP SURGERY.
Patient problems: Insufficient Information
MAUDE report 17606957 ↗MalfunctionAug 21, 2023Break; Break
INSTRUMENT BROKE DURING KNEE SURGERY.
Patient problems: Insufficient Information
MAUDE report 17585988 ↗MalfunctionApr 4, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR BROKE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16672475 ↗MalfunctionNov 9, 2022Break; Break
INSTRUMENT BROKE DURING HIP SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15763196 ↗MalfunctionOct 12, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
STAFF HAVE INDICATED ALL ITEMS REQUIRE REPLACEMENT DUE TO WEAR AND TEAR OVER TIME. THE FEMORAL HEAD TRIALS ARE WORN AND SCRATCHED. THE FEMORAL HEAD IMPACTOR TIP IS ALSO VERY WORN AWAY FROM SEVERAL USES. THE IMPACTOR TIPS ARE CROSS THREADED AND NO LONGER THREAD ONTO THE WHITE HANDLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15590991 ↗MalfunctionSep 19, 2022Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15446215 ↗MalfunctionMay 12, 2022Break; Break
TIP OF THE IMPACTOR BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED AND MATCHED TOGETHER TO MAKE SURE THAT NO SMALLER PIECES WERE CREATED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14371516 ↗MalfunctionFeb 21, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE IMPACTOR TIP IN QUESTION. IN THE SURGERY, THE IMPACTOR TIP WAS BROKEN DURING A LINER IMPLANTING WITH A HAMMER. IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13569572 ↗MalfunctionJan 20, 2022Break; Break
IMPACTOR TIP BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED. NO ADVERSE EVENT OR DELAY WAS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13311022 ↗MalfunctionJun 1, 2021Break; Break
IT WAS REPORTED AS "THE 32MM IMPACTOR TIP IS BROKEN AND NEEDS TO BE REPLACED.." NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11915571 ↗MalfunctionMar 9, 2021Break; Break
IT WAS REPORTED THAT BLACK PLASTIC ON HANDLE HAS CRACKED AND HAS FALLEN OFF THE PLASTIC TIPS FOR THE 32 AND 36 MM IMPACTORS ARE SHEARED OFF. NO SURGICAL DELAY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11444224 ↗MalfunctionFeb 15, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
(B)(6) STAFF AT (B)(6) REPORTING A DAMAGED IMPACTOR TIP FROM CONSIGNMENT TRAY. NO INFORMATION ON WHEN THE BREAKAGE OCCURS HOWEVER A REPLACEMENT ITEM IS REQUIRED. TIP OF IMPACTOR (THAT ATTACHES TO HANDLE) HAS BROKEN OFF. LOT NUMBER IS UNKNOWN DUE TO WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11328211 ↗MalfunctionDec 16, 2020Break; Break
IT WAS REPORTED THAT TIP OF THE IMPACTOR WAS BROKEN OFF INTO TWO PIECES AND FOUND IN SPD. THE BROKEN OFF PIECE WAS THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11020467 ↗MalfunctionJul 15, 2020Break; Break
IT WAS REPORTED THAT THE 32MM BLUE LINER IMPACTOR BROKE INTO 2 PIECES WHILE IMPACTING LINER. BOTH PIECES WERE RETRIEVED FROM THE PATIENT AND WERE RETURNED TO THE OFFICE. THIS DID NOT DELAY SURGERY TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10277964 ↗MalfunctionJul 10, 2020Break; Break
MIS IMPACTOR TIP BROKE DURING LT TOTAL HIP SURGERY. ALL BROKEN PIECES RETRIEVED AND NO DELAY IN SURGICAL TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10260986 ↗MalfunctionFeb 25, 2020Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP (P/N: 920010027) WHICH WAS ATTACHED WITH A DEDICATED HOLDER WAS BROKEN DURING THE THA SURGERY ON (B)(6) 2020 WHEN STRIKING IT WITH A HUMMER AT THE TIME OF IMPLANTING A LINER. THE LINER WAS IMPLANTED WITHOUT PROBLEMS AND IT WAS CONFIRMED THAT THERE WAS NO FRAGMENT PART IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9750483 ↗MalfunctionJan 27, 2020Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP (P/N: 920010027) WHICH WAS ATTACHED WITH A DEDICATED HOLDER WAS BROKEN DURING THE THA SURGERY ON (B)(6) 2019 WHEN STRIKING IT WITH A HUMMER FOR IMPLANTING A LINER. THE LINER WAS PLACED SUCCESSFULLY, AND THE SURGERY WAS COMPLETED. IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT AND THERE WAS NO HARM TO THE PATIENT. IT WAS CONFIRMED THAT THERE WERE NO BROKEN FRAGMENTS IN THE PATIENT BODY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9635195 ↗MalfunctionOct 9, 2019Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP FOR 32MM HEAD/BLUE (P/N: UNKNOWN) WAS BROKEN WHEN STRIKING THE LINER DURING THE THA SURGERY ON (B)(6) 2019. IT WAS CONFIRMED THAT THE LINER WAS INSERTED WITHOUT PROBLEM, IT WAS ALSO CONFIRMED THAT THERE WERE NO REMAINING BROKEN FRAGMENTS IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9172226 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.