S-ROM 56-3020NRecalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM Total Hip System FEMORAL STEM Straight Long 36+21 CR NECK +8 11/13 TAPER 20x15x225 Lateral · Class 3 · Implant
All models of S-ROM (92)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295177340), received between Aug 21, 2018 and Apr 5, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
PFS ALLEGES THAT SOMETIME AROUND 2015, THE PATIENT FELL ON HIS RIGHT SIDE AND BROKE THE FEMORAL STEM LOOSE. PATIENT HAD TO BE CAREFUL IN WAKING OR IT CAN LEAD TO VERY EXCRUCIATING KNEE PAIN. DOI: (B)(6) 2007 - DOR: NOT INDICATED (RIGHT HIP).
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 8487740 ↗InjuryAug 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PPF ALLEGES INFECTION REQUIRING INTRAVENOUS ANTIBIOTICS AFTER FIRST REVISION. DOI: (B)(6) 2009- DOR: UNKNOWN; (LEFT HIP).
Patient problems: Unspecified Infection
MAUDE report 7801013 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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