Offset Cup Impactor - 3/8-16 interface 50341105Recalls & reported problems
Incipio Devices SA · Offset Cup Impactor for hip arthroplasty · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630055304735), received between Dec 12, 2024 and Dec 12, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 30, 2024Open, Classified
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Z-0549-2025 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Crack3
- Manufacturing, Packaging or Shipping Problem3
- Nonstandard Device3
- Solder Joint Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2024Crack; Nonstandard Device; Solder Joint Fracture; Manufacturing, Packaging or Shipping Problem; Crack; Nonstandard Device; Solder Joint Fracture; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) INCIPIO R3 OFFSET CUP IMPACTOR CRACKED WHILE IMPACTING THE CUP. THE PROCEDURE RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915083 ↗MalfunctionDec 12, 2024Crack; Nonstandard Device; Solder Joint Fracture; Manufacturing, Packaging or Shipping Problem; Crack; Nonstandard Device; Solder Joint Fracture; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A THR SURGERY, UPON IMPACTION OF THE CUP, THE STRIKE PLATE OF ONE (1) INCIPIO OFFSET CUP IMPACTOR COMPLETELY BROKE OFF AND FELL ON THE FLOOR. THE PROCEDURE RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914633 ↗MalfunctionDec 12, 2024Crack; Nonstandard Device; Solder Joint Fracture; Manufacturing, Packaging or Shipping Problem; Crack; Nonstandard Device; Solder Joint Fracture; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A THR, THE STRIKE PLATE OF A INCIPIO OFFSET CUP IMPACTOR BROKE OFF WHILE IMPACTING THE CUP. IT IS UNKNOWN IF PIECES FELL INTO PATIENT. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914150 ↗
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.