HIP Instruments 01.22.10.0143Recalls & reported problems
Medacta International SA · Inserter Rod · Class 1
Data updated Oct 13, 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 07630040739221), received between May 28, 2024 and May 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Fracture1
Patient problems
- Unequal Limb Length1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2024Fracture; Difficult to Remove; Fracture; Difficult to Remove
THE DISTAL STEM Ø12MM L 180MM WAS NOT PLACED DEEP ENOUGH DUE TO INSUFFICIENT REAMING. WHEN TRYING TO REMOVE THE DISTAL STEM TO REAM FURTHER, THE EXTRACTION DEVICES BROKE AND IT WAS NOT POSSIBLE TO REMOVE THE STEM. A 40MM PROXIMAL STEM AND AN XS HEAD FROM COMPETITOR HAVE BEEN IMPLANTED. THE OPERATION WAS COMPLETED WITH A LEG LENGTHENING OF 6MM. THE PATIENT BONE WAS VERY SCLEROTIC. TRIAL STEM NOT USED.
Patient problems: Unequal Limb Length
MAUDE report 19403911 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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