N/A 72200626FRecalls & reported problems
Smith & Nephew, Inc. · UNIVERSAL HIP DISTRACTOR WITH LEATHER BOOT - REFURBISHED · Class 1
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 00885556571439), received between Mar 22, 2022 and Mar 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Material Deformation1
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 22, 2022Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, AT THE FINAL CLOSING, THE BED COLLAPSED AND SUDDENLY FELL. THE DOCTORS GRABBED THE PATIENT BEFORE TOUCHING THE FLOOR. PART OF THE BED HAD BROKEN, AND PART BENT. THE CLAMP THAT WAS CONNECTED TO THE BED RAIL WAS BROKEN AND THE SCREW THAT CONNECTED THE LEG TO THE BED BECAME TWISTED. NO DELAY WAS REPORTED AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13847335 ↗
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- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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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