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S-ROM 52-1553Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM CRUCIATE HEAD PERIPHERAL SCREW 5mm x 35mm · Class 2 · Implant

All models of S-ROM (92)

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 10603295170747), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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

  • Incomplete or Missing Packaging1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 15, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

    IT WAS REPORTED THAT THE PART WAS FOUND TO BE MISSING FROM PACKAGING DURING RETURNS INSPECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7967243 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

Sources and updates

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