S-ROM 52-1504Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM CRUCIATE HEAD PERIPHERAL SCREW 5mm x 40mm · Class 2 · Implant
All models of S-ROM (92)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295170662), received between Aug 20, 2018 and Apr 17, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Loose or Intermittent Connection1
- Loss of Osseointegration1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Discomfort1
- Inadequate Osseointegration1
- Insufficient Information1
- Necrosis1
- Not Applicable1
- Osteolysis1
- Scar Tissue1
- Tissue Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT STAFF WENT TO OPEN AN SROM PERIPHERAL SCREW AND WHEN THE RN NOTICED THE STERILE PACKAGING WAS NOT SEALED ON THE BOTTOM. THIS STILL HAD THE PLASTIC WRAPPING ON THE OUTSIDE SO IT WAS NOT LIKE IT WAS OPENED AND PUT BACK IN THE BOX BEFORE. THE ADHESIVE ON THE PACKAGING SEEMS TO HAVE NOT BEEN/BARELY APPLIED TO THIS AREA. SURGICAL DELAY WAS UNKNOWN. DOE: (B)(6) 2025 AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 21855173 ↗InjuryApr 25, 2019Loss of Osseointegration; Loss of Osseointegration
PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES LOOSENING OF CUP, METAL WEAR, AND METALLOSIS.
Patient problems: Inadequate Osseointegration; Tissue Damage
MAUDE report 8550101 ↗InjuryAug 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES DISCOMFORT, ASYMMETRIC WEAR AND INSTABILITY. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY PATIENT WAS REVISED DUE TO FAILED ACETABULAR COMPONENT. REVISION NOTES REPORTED OF LARGE AMOUNT OF SCAR TISSUE, OSTEOLYSIS, 2 PERIPHERAL SCREWS WERE REMOVED, AND FOUND THE CUP TO BE LOOSE. CLINICAL VISITS REPORTED OF LOOSE ACETABULAR CUP, AND OSTEOLYTIC DEFECT. DOI: (B)(6) 2004; DOR: (B)(6) 2005; (LEFT HIP).
Patient problems: Discomfort; Necrosis; Not Applicable; Osteolysis; Scar Tissue
MAUDE report 7796988 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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