S-ROM 1365-63-500Recalls & reported problems
Depuy (Ireland) · S-ROM M-Spec FEMORAL HEAD Diameter 44mm +3 Offset 11/13 TAPER · Class 2 · Implant
All models of S-ROM (185)
Data updated Oct 18, 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 10603295034131), received between Nov 23, 2022 and Sep 18, 2026 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Foreign Body Reaction1
- Pain1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50823142 ↗InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UNF AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD PATIENT WAS REVISED TO ADDRESS PAIN. REVISION NOTES STATED THAT THERE WAS BROWNISH FLUID EMANATED FROM THE HIP JOINT AND COLLECTION OF FLUID OVER THE FEMORAL NERVE THAT IS PALPABLE ON PATIENT'S ANTERIOR THIGH IN THE PERINEAL REGION AND WAS ABLE TO DECOMPRESS WHICH WAS ALSO THE CHOCOLATE BROWN WATERY TYPE FLUID WITH NO PURULENT MATERIAL NOTED. THE LABORATORY VALUE OF COBALT WAS BELOW 7PPB. DOI: (B)(6) 2008. DOR: (B)(6) 2021. (RIGHT HIP).
Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema
MAUDE report 15850715 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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