NA 9200-10-026Recalls & reported problems
Depuy (Ireland) · DePuy MI System IMPACTOR TIP 28mm · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295221869), received between Apr 29, 2020 and Mar 8, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024Break; Break
IT WAS REPORTED THAT THE 28MM CUP IMPACTOR SPRING IS BROKEN ON MARATHON INSERTER. DID THE EVENT OCCUR DURING STERILE PROCESSING? NO. DID THE EVENT OCCUR DURING FIELD INSPECTION? NO. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY ? UNKNOWN. (B)(4). DEVICE PROPERTY OF ? NONE. DEVICE IN POSSESSION OF ? DEPUY. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18864870 ↗MalfunctionJul 22, 2020Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN THE SETS AND WERE NOT USED. THE TIPS WERE SHEARED OFF AT THE END OF THE PLASTIC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10309511 ↗MalfunctionApr 29, 2020Break; Break
IT WAS REPORTED THAT THE TIPS OF THE PLASTIC INSERTER WERE BROKEN OFF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10011787 ↗
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.