S-ROM 87-3557Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM Total Hip System POLY-DIAL LINER 32mm 0 DEGREES L 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
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295218487), received between Nov 9, 2017 and Nov 30, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Dislocated6
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation6
- No Code Available3
- Joint Laxity1
- Not Applicable1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE DISLOCATED HIP WITH THE SROM CUP AND COMPETITIVE STEM. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 18235937 ↗InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. NEW LINER IMPLANTED. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 15237549 ↗InjuryMar 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9825571 ↗InjuryJun 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED SEVERAL TIMES AND LOCKING RING OFF OF LINER AS EVIDENCED BY X RAYS. SURGEON OPTED TO PULL POLY LINER OUT WITH LOCKING SCREWS AND REPLACE CONSTRAINING LINER, LOCKING SCREWS, AND HEAD. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8709103 ↗InjuryFeb 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR; (B)(6) 2019; RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8345377 ↗InjuryOct 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAD HEAD AND LINER REVISED DUE TO DISLOCATION.
Patient problems: Joint Dislocation; Not Applicable
MAUDE report 7934299 ↗InjuryJan 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2018. UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 7227293 ↗InjuryNov 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7016765 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page