S-ROMRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 92 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 684
- Deaths reported
- 0
- Injuries reported
- 462
- Recalls
- 0
We found 92 models of S-ROM by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 684 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2013 and Sep 11, 2026 — classified as 462 injuries, 222 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (108 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported S-ROM problems
Device problems
- Adverse Event Without Identified Device or Use Problem189
- Naturally Worn108
- Device Dislodged or Dislocated83
- Break67
- Insufficient Device Problem Information53
- Illegible Information41
- Device-Device Incompatibility40
- Loss of Osseointegration29
Patient problems
- Pain208
- No Code Available201
- No Consequences Or Impact To Patient117
- Foreign Body Reaction96
- No Clinical Signs, Symptoms or Conditions84
- Joint Dislocation82
- Test Result66
- Tissue Damage57
S-ROM models
92 models, most reported first. Each model has its own page with its reports, recalls and device details.
- S-ROM 1365-31-000Prosthesis, hip, semi-constrained, metal/polymer, cemented140 reports
- S-ROM 1365-32-000Prosthesis, hip, semi-constrained, metal/polymer, cemented137 reports
- S-ROM 54-0030REAMER61 reports
- S-ROM 1365-26-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED34 reports
- S-ROM 55-6071PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED26 reports
- S-ROM 2576-36-012TEMPLATE19 reports
- S-ROM 2576-36-008TEMPLATE18 reports
- S-ROM 56-3622Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented14 reports
- S-ROM 55-6070PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED13 reports
- S-ROM 55-6072PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED13 reports
- S-ROM 55-0295Prosthesis, hip, semi-constrained, metal/polymer, cemented11 reports
- S-ROM 2576-52-100WRENCH9 reports
- S-ROM 2576-00-008REAMER8 reports
- S-ROM 2576-02-023REAMER8 reports
- S-ROM 87-3557Prosthesis, hip, constrained, cemented or uncemented, metal/polymer8 reports
- S-ROM 2576-02-025REAMER7 reports
- S-ROM 2576-36-006TEMPLATE7 reports
- S-ROM 2576-05-023TEMPLATE6 reports
- S-ROM 2576-20-130TEMPLATE6 reports
- S-ROM 2576-30-004TEMPLATE6 reports
- S-ROM 52-8323Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- S-ROM 55-6073PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- S-ROM 2576-02-017REAMER5 reports
- S-ROM 2576-16-130TEMPLATE5 reports
- S-ROM 2576-05-021TEMPLATE4 reports
- S-ROM 52-1552PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- S-ROM 53-4107ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- S-ROM 87-3435Prosthesis, hip, constrained, cemented or uncemented, metal/polymer4 reports
- S-ROM 2576-08-020INSTRUMENT, CUTTING, ORTHOPEDIC3 reports
- S-ROM 2576-18-130TEMPLATE3 reports
- S-ROM 52-1504PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- S-ROM 52-1554PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- S-ROM 53-2860CLAMP3 reports
- S-ROM 53-4106ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- S-ROM 55-0235Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- S-ROM 55-6074PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- S-ROM 56-3118NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- S-ROM 56-3120NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- S-ROM 2576-02-027REAMER2 reports
- S-ROM 2576-05-019TEMPLATE2 reports
- S-ROM 2576-11-110TEMPLATE2 reports
- S-ROM 2576-22-130TEMPLATE2 reports
- S-ROM 52-1503PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- S-ROM 52-6678Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- S-ROM 52-6682Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- S-ROM 52-8330Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- S-ROM 53-5362Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- S-ROM 53-5557REAMER2 reports
- S-ROM 56-3020NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- S-ROM 2576-00-004TEMPLATE1 report
- S-ROM 2576-02-015REAMER1 report
- S-ROM 2576-02-117REAMER1 report
- S-ROM 2576-05-029TEMPLATE1 report
- S-ROM 2576-05-117TEMPLATE1 report
- S-ROM 2576-08-018INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- S-ROM 2576-11-106TEMPLATE1 report
- S-ROM 2576-11-108TEMPLATE1 report
- S-ROM 2576-11-112TEMPLATE1 report
- S-ROM 2576-13-110TEMPLATE1 report
- S-ROM 2576-24-130TEMPLATE1 report
- S-ROM 52-1505PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- S-ROM 52-1553PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- S-ROM 52-6514NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 52-6516LProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 52-6516NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 52-6518LProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 52-6518NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 53-2504FSCREWDRIVER1 report
- S-ROM 53-4212ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- S-ROM 53-5306Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 53-5364Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 53-5366Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 53-5556REAMER1 report
- S-ROM 53-5606GAUGE, DEPTH1 report
- S-ROM 53-5612BIT, DRILL1 report
- S-ROM 53-5710IMPACTOR1 report
- S-ROM 53-6346TEMPLATE1 report
- S-ROM 53-8002TEMPLATE1 report
- S-ROM 53-8012TEMPLATE1 report
- S-ROM 54-0012INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- S-ROM 55-6075PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- S-ROM 56-3018LProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3018NProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3020RProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3120LProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3122LProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3122RProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3216LProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3624Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 56-3626Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM 87-5973Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- S-ROM 87-5987Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
Recent S-ROM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Dislodged or Dislocated
It was reported that patient was revision due to dislocation.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50734465 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had infected hip. Washout/I&D was performed. Head and poly were swapped.Affected side- Left Hip.
Patient problems: Unspecified Infection
MAUDE report 50452562 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Patient had infected hip. Washout/I&D was performed. Head and poly were swapped.Affected side-Left.
Patient problems: Unspecified Infection
MAUDE report 50452395 ↗InjuryJul 27, 2026Osseointegration Problem
Patient was revised due to loosening of the sleeve and stem at the bone to implant interface. No delay. No harm to patient. No additional information is available.DOI: ON (b)(6) 2019,DOR: ON (b)(6) 2026,Affected side: Left hip.
Patient problems: Inadequate Osseointegration
MAUDE report 50017196 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE ACETABULUM NEEDED TO BE REVISED. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 25461885 ↗InjuryMay 5, 2026Osseointegration Problem
IT WAS REPORTED ON (B)(6) 2003, THE PATIENT UNDERWENT THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAYS. THE PATIENT VISITED THE HOSPITAL DUE TO POSTOPERATIVE DISLOCATION. REVISION SURGERY WAS PLANNED BECAUSE FINDINGS INDICATING POSSIBLE CUP LOOSENING WERE OBSERVED. ON (B)(6) 2026, REVISION SURGERY WAS PERFORMED AND IMPLANTS REPLACEMENT WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 25081508 ↗InjuryMay 5, 2026Osseointegration Problem
IT WAS REPORTED ON (B)(6) 2003, THE PATIENT UNDERWENT THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAYS. THE PATIENT VISITED THE HOSPITAL DUE TO POSTOPERATIVE DISLOCATION. REVISION SURGERY WAS PLANNED BECAUSE FINDINGS INDICATING POSSIBLE CUP LOOSENING WERE OBSERVED. ON (B)(6) 2026, REVISION SURGERY WAS PERFORMED AND IMPLANTS REPLACEMENT WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 25079522 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF MOM LINER AND HEAD DUE TO PAIN AND METAL REACTION. DOI: (B)(6) 2007. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 24926890 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24790179 ↗MalfunctionMar 24, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675528 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WANTED MORE LEG LENGTH. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Physical Asymmetry
MAUDE report 24674945 ↗MalfunctionMar 23, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THIS DID NOT OCCUR INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24666797 ↗MalfunctionMar 23, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THIS DID NOT OCCUR INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665626 ↗MalfunctionMar 23, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665138 ↗MalfunctionMar 23, 2026Illegible Information
IT WAS REPORTED THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. EVENT DID NOT OCCUR INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663007 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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