DURALOC 2360-71-000Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC STR CUP IMPACTOR · Class 1
Quick summary
This DePuy Duraloc cup impactor is a surgical tool used to seat a cup implant. Its 719 reports, with 1 injury and no deaths, mostly describe handles that break, crack or wear down, and parts that bend, twist or no longer fit other devices. The most recent reports describe a handle that cracked into two pieces and threads that warped so the tool no longer threads into a cup. 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
- 716
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 716 adverse event reports that list this exact device (DI 10603295119906), received between Jul 18, 2017 and Aug 17, 2026 — classified as 1 injury, 715 malfunctions.
The most frequently reported specific device problem is “Break” (269 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
- Break269
- Naturally Worn163
- Crack144
- Material Deformation100
- Material Twisted/Bent87
- Device-Device Incompatibility78
- Scratched Material29
- Appropriate Device Problem Term/Code Not Available23
Patient problems
- No Clinical Signs, Symptoms or Conditions378
- No Consequences Or Impact To Patient248
- Insufficient Information46
- No Information38
- Not Applicable13
- No Code Available8
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 716 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Break; Crack
It was reported that white plastic handle cracked. During in-house engineering evaluation it was determined that the handle was broken into 2 pieces.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282664 ↗MalfunctionAug 5, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147041 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046000 ↗MalfunctionJul 15, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25829955 ↗MalfunctionJul 15, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25829663 ↗MalfunctionJul 6, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25715149 ↗MalfunctionJun 25, 2026Break
IT WAS REPORTED THAT DURING STERILE PROCESSING (SPD) FOUND THAT THE THREADS WERE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623183 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT THE PLASTIC ON THE PINN CUP HANDLE BROKE AFTER THE HITTING HANDLE. IT WAS REPORTED THAT NOTHING HAPPENED IN SURGERY. IT WAS REPORTED THAT ANOTHER HANDLE WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25554632 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT THE IMPACTOR DEVICE BROKE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375618 ↗MalfunctionMay 28, 2026Break; Illegible Information
IT WAS REPORTED THAT WHITE HANDLE BROKE DURING IMPACTING LINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25316147 ↗MalfunctionMay 26, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY THE LINER IMPACTOR WAS WORN AND ITS THREADS WERE STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25281017 ↗MalfunctionMay 20, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE IMPACTOR HANDLE WAS STRIPPED, THE SHELL WOULD NOT SCREW IN. THERE WAS NO SURGICAL DELAY, ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234033 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THE IMPACTOR BROKE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202871 ↗MalfunctionMay 15, 2026Material Deformation
IT WAS REPORTED THAT T HANDLE WAS CRACKED, BROACHES WERE CHIPPED/SCRATCHED AND DID NOT FIT INTO BROACH HANDLES. THE CUP IMPACTOR SCREW WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185622 ↗MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED THAT THE THREADS ON THE DURALOC STR CUP IMPACTOR WERE STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163881 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE THREAD WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159836 ↗MalfunctionMay 7, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE LINER IMPACTORS THREADS WERE DAMAGED AND THE TIPS CANNOT THREAD ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116401 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING IMPACTION. THE DEVICE BROKE INTO TWO FOR MORE PIECES, THE WHITE PLASTIC OF THE HANDLE FRACTURED OFF INTO PIECES. THE FRAGMENTS WERE RECEIVED AND DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059824 ↗MalfunctionApr 30, 2026Material Deformation
IT WAS REPORTED THAT THREADS OF THE DEVICE ARE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045689 ↗MalfunctionApr 20, 2026Material Deformation
IT WAS REPORTED THAT THE CUP-HANDLE THREADS WERE DAMAGED AND STRIPPED AND REQUIRED REPLACEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928757 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT PLASTIC HANDLE BROKE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903155 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT PLASTIC HANDLE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24894858 ↗MalfunctionApr 15, 2026Break; Crack
IT WAS REPORTED THAT IMPACTOR'S WHITE HANDLE CRACKED. ALL PIECES WERE RETRIEVED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885811 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT THE DURALOC STR CUP IMPACTOR BROKE DURING THE LINER IMPACTOR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715060 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT THE IMPACTOR HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617249 ↗
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
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
- SELF CENTERING 2055-13-000Depuy (Ireland) · IMPACTOR324 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.