REVISION Hip Manual Impactor (REF 9038.10.110)Recalls & reported problems
Limacorporate SPA · Manual Impactor · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390039499), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Mechanical Problem; Mechanical Problem
DURING A PRIMARY HIP SURGERY PERFORMED ON (B)(6) 2025, THE REVISION FEMORAL STEM 200 MM-14 MM AND THE REVISION NECK 50 MM COULD NOT BE TIGHTENED TO THE END. IT WAS IMPOSSIBLE TO TIGHTEN THE SAFETY SCREW TO THE END. ACCORDING TO THE RECEIVED INFORMATION, AFTER CHECKING THE DEVICES, DEFORMATION WAS FOUND IN THE THREADED PART OF THE REVISION - MANUAL IMPACTOR (PRODUCT CODE 9038.10.110, LOT #J105001504) AND THE THREADED PART OF THE STEM. THEREFORE, THE SCREW COULD NOT BE INSERTED. THE SURGEON THEN TRIED TO USE A STEM FROM ANOTHER COMPANY (FOR A DISTAL FIXATION), BUT IT WAS UNABLE TO FIX THE IMPLANT. AS A RESULT, THE SURGERY WAS COMPLETED USING ANOTHER REVISION STEM 200-15 MM STEM (3811.15.020, LOT #1606827) AND NECK 60 MM (7515.15.010, LOT #2429358). IT WAS REPORTED THAT A DIFFERENT IMPACTOR WAS USED TO IMPLANT THE SECOND STEM. THE SURGICAL TIME WAS EXTENDED BY 120 MINUTES DUE TO THIS EVENT. IT WAS REPORTED THAT THE SURGICAL TECHNIQUE WAS FOLLOWED. EVENT HAPPENED IN JAPAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688252 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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