S-ROM ZTT 55-0778Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM Total Hip System ZTT Undersize Proximal Sleeve POROUS COATED 24 F LRG FITS: 26 x 21 STEM Cone: F Triangle: LRG 26 INTERNAL DIAMETER · Class 3 · Implant
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 10603295175704), received between Aug 13, 2020 and Aug 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2020Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S HIP WAS DONE OVER 20 YEARS AGO. DO NOT HAVE ACCESS TO THE EXACT DATE WHEN PREVIOUS SURGERY WAS DONE. ALSO DIDN'T HAVE ACCESS TO ANY OF THE LOT NUMBERS OR KNOW WHAT SIZE HEAD BALL WAS USED BECAUSE THE STEM CAME OUT WITH THE 28 HEAD BALL STILL ATTACHED. SURGEON REVISED STEM BECAUSE XRAYS SHOWED THE SLEEVE MAY HAVE SUBSIDED. THE SURGEON TOOK OUR LINER FOR STRYKER CUP AND REPLACED IT WITH A NEW LINER. HE ALSO REPREPPED THE FEMUR FOR A CALCAR REPLACEMENT BOWED STEM, BIGGER SLEEVE OPTION, AND NEW 40 HEAD FOR ADDED STABILITY. DOI: 20 YEARS AGO. DOR: (B)(6) 2020; RIGHT HIP.
Patient problems: No Code Available
MAUDE report 10402774 ↗
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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