S-ROM 56-3216LRecalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM Total Hip System FEMORAL STEM Left Long 30 STD NECK +4 11/13 TAPER 16x11x205 Lateral · Class 3 · Implant
All models of S-ROM (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295178156), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.
Most reported problems
Device problems
- Loss of Osseointegration1
- Migration1
Patient problems
- Inadequate Osseointegration1
- Injury1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration
PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT FAILURE. IT WAS NOTED THAT HER SUBTROCH OSTEOTOMY FAILED AND FEMORAL COMPONENT SUBSIDED. THERE WAS NOTABLE PAIN AND LEG LENGTH INEQUALITY. REVISION NOTES REPORTED SIGNIFICANT AMOUNT OF BONE LOSS IN THE GREATER TROCHANTER INCONTINUITY, A NON-DEPUY PLATE WAS NOTED TO HAVE FAILED, AND THE STEM WAS GROSSLY LOOSE. DOI: (B)(6) 2006; DOR: (B)(6) 2006; LEFT HIP.
Patient problems: Inadequate Osseointegration; Injury; No Code Available; Pain
MAUDE report 9729239 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices
- BIOLOX DELTA 1365-36-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented839 reports
- BIOLOX DELTA 1365-36-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented643 reports
- PINNACLE POROCOAT 1217-22-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented335 reports
- PINNACLE POROCOAT 1217-22-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented263 reports
- BIOLOX DELTA 1365-36-330Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented255 reports
- PINNACLE POROCOAT 1217-22-050Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented253 reports
- PINNACLE POROCOAT 1217-22-056Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented220 reports
- SUMMIT POROCOAT 1570-11-120Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death204 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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