S-ROM 87-3435Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM Total Hip System POLY-DIAL LINER 28mm 0 DEGREES M SERIES Constrained With Ring · Class 2 · Implant
All models of S-ROM (92)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295218289), received between Feb 28, 2018 and Sep 18, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 Dislodged or Dislocated2
- Fracture1
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- Joint Dislocation2
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Tissue Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245847 ↗InjuryJan 6, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO THE FEMORAL HEAD DISLOCATED, ONCE HEAD WAS REMOVED, SURGEON NOTICED CONSTRAINED LINER HAD BEEN CRACKED. REPLACED CONSTRAINED LINER AND IMPLANTED A 28+12 SROM HEAD. ORIGINAL IMPLANT DATE WAS UNKNOWN. IT WAS UNKNOWN IF ANY LOOSENING OCCURRED. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 16115872 ↗InjuryMar 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATES THAT THE SURGEON'S PATIENT PRESENTED PAIN IN HER RIGHT HIP. AFTER OPENING HER RIGHT CAPSULE, HE COULD SEE A FAIR AMOUNT OF METALLOSIS IN THE FEMORAL/TRUNION AREA OF THE CONSTRUCT. DOI: UNKNOWN; DOR; (B)(6) 2018; RIGHT HIP.
Patient problems: Pain; Tissue Damage
MAUDE report 7338185 ↗InjuryFeb 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF A SROM M-SERIES 28MM 0 DEGREES CONSTRAINED LINER. IT WAS ALSO INDICATED THAT SROM M-SERIES 28MM 0 DEGREES CONSTRAINED LINER WAS INITIALLY AND UNSUCCESSFULLY IMPLANTED DUE TO DAMAGE AFTER IT WOULD NOT TURN AND LOCK INTO THE CUP. IT WAS DECIDED TO IMPLANT ANOTHER SROM M-SERIES 28MM 0 DEGREES CONSTRAINED LINER WHICH WAS SUCCESSFUL. DOI: (B)(6) 2011; DOR: (B)(6) 2018; LEFT HIP. THERE WAS A SURGICAL DELAY OF 10 MINUTES.
Patient problems: Joint Dislocation
MAUDE report 7302678 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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