S-ROM 52-1552Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM CRUCIATE HEAD PERIPHERAL SCREW 5mm x 25mm · 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 10603295170730), received between Nov 9, 2017 and Aug 6, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration3
- Pain2
- No Code Available1
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE CUP. DOI: (B)(6) 1997 ; DOR: (B)(6) 2000; (LEFT HIP).
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 12285824 ↗InjuryAug 6, 2021Osseointegration Problem; Osseointegration Problem
THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE CUP. DOI: (B)(6) 1997 ; DOR: (B)(6) 2000; (LEFT HIP).
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 12285822 ↗InjuryDec 6, 2018Loss of Osseointegration; Loss of Osseointegration
THIS REVISION HIP WAS FOR REVISION OF LOOSE ACETABULAR COMPONENT. NOT CONFIRMED BUT APPEARED TO BE A REVISION OF A PREVIOUS HIP ARTHROPLASTY. OSTEOLYSIS PRESENT IN PROXIMAL FEMUR HOWEVER FEMORAL COMPONENT REMAINED INSITU AS WELL FIXED.
Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis
MAUDE report 8137167 ↗InjuryNov 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7016783 ↗
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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