S-ROMRecalls & reported problems across all models
Depuy (Ireland) · 185 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,201
- Deaths reported
- 4
- Injuries reported
- 1,261
- Recalls
- 0
We found 185 models of S-ROM by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 2,201 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2013 and Sep 24, 2026 — classified as 4 deaths, 1,261 injuries, 936 malfunctions.
The most frequently reported specific device problem is “Break” (207 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 Problem631
- Break207
- Naturally Worn195
- Device Dislodged or Dislocated182
- Device-Device Incompatibility176
- Illegible Information163
- Material Deformation120
- Scratched Material114
Patient problems
- Pain601
- No Code Available552
- No Consequences Or Impact To Patient423
- No Clinical Signs, Symptoms or Conditions408
- Test Result331
- Discomfort196
- Tissue Damage187
- Joint Dislocation181
S-ROM models
185 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- S-ROM 53-0302INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT185 reports
- S-ROM 52-3418Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented168 reports
- S-ROM 56-3517Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented129 reports
- S-ROM 56-3618Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented121 reports
- S-ROM 52-3420Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 deaths73 reports
- S-ROM 56-3620Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented60 reports
- S-ROM 52-3192Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented51 reports
- S-ROM 53-0360ORTHOPEDIC MANUAL SURGICAL INSTRUMENT49 reports
- S-ROM 52-2029Prosthesis, hip, semi-constrained, metal/polymer, cemented44 reports
- S-ROM 52-2028Prosthesis, hip, semi-constrained, metal/polymer, cemented39 reports
- S-ROM 52-3193Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented34 reports
- S-ROM 53-4400EXTRACTOR34 reports
- S-ROM 1365-43-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death32 reports
- S-ROM 1365-44-500Prosthesis, hip, semi-constrained, metal/polymer, cemented31 reports
- S-ROM 2576-16-100TEMPLATE30 reports
- S-ROM 2576-18-110TEMPLATE30 reports
- S-ROM 56-3516Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented29 reports
- S-ROM 52-2032Prosthesis, hip, semi-constrained, metal/polymer, cemented27 reports
- S-ROM 2576-13-100TEMPLATE26 reports
- S-ROM 1365-45-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death25 reports
- S-ROM 2576-16-110TEMPLATE25 reports
- S-ROM 52-2033Prosthesis, hip, semi-constrained, metal/polymer, cemented25 reports
- S-ROM 53-6450ORTHOPEDIC MANUAL SURGICAL INSTRUMENT25 reports
- S-ROM 1365-42-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED24 reports
- S-ROM 53-1500PUNCH, SURGICAL24 reports
- S-ROM 2576-18-100TEMPLATE23 reports
- S-ROM 2576-16-115TEMPLATE22 reports
- S-ROM 52-3191Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented22 reports
- S-ROM 52-3393Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented22 reports
- S-ROM 87-5953Prosthesis, hip, semi-constrained, metal/polymer, cemented22 reports
- S-ROM 1365-36-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED21 reports
- S-ROM 53-5801DRIVER, PROSTHESIS20 reports
- S-ROM 56-3518Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented20 reports
- S-ROM 87-5955Prosthesis, hip, semi-constrained, metal/polymer, cemented20 reports
- S-ROM 2576-18-105TEMPLATE19 reports
- S-ROM 52-2022Prosthesis, hip, semi-constrained, metal/polymer, cemented18 reports
- S-ROM 2576-16-105TEMPLATE17 reports
- S-ROM 2576-18-115TEMPLATE17 reports
- S-ROM 87-5956Prosthesis, hip, semi-constrained, metal/polymer, cemented17 reports
- S-ROM 1365-16-500Prosthesis, hip, semi-constrained, metal/polymer, cemented16 reports
- S-ROM 2576-36-000TEMPLATE16 reports
- S-ROM 52-2034Prosthesis, hip, semi-constrained, metal/polymer, cemented16 reports
- S-ROM 52-3194Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented16 reports
- S-ROM 2576-11-100TEMPLATE15 reports
- S-ROM 52-3422Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented15 reports
- S-ROM 1365-47-500Prosthesis, hip, semi-constrained, metal/polymer, cemented14 reports
- S-ROM 2576-18-125TEMPLATE14 reports
- S-ROM 52-3291Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented14 reports
- S-ROM 52-2030Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- S-ROM 53-1206EXTRACTOR12 reports
- S-ROM 2576-02-019REAMER11 reports
- S-ROM 2576-20-125TEMPLATE11 reports
- S-ROM 52-3292Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented11 reports
- S-ROM 56-3514Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented11 reports
- S-ROM 1365-18-500Prosthesis, hip, semi-constrained, metal/polymer, cemented10 reports
- S-ROM 2576-02-021REAMER10 reports
- S-ROM 2576-15-100TEMPLATE10 reports
- S-ROM 2576-20-110TEMPLATE10 reports
- S-ROM 2576-20-115TEMPLATE10 reports
- S-ROM 2576-16-125TEMPLATE9 reports
- S-ROM 53-2029ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- S-ROM 2365-31-500TEMPLATE8 reports
- S-ROM 2576-00-002OSTEOTOME8 reports
- S-ROM 2576-20-100TEMPLATE8 reports
- S-ROM 2576-30-000TEMPLATE8 reports
- S-ROM 2576-09-100TEMPLATE7 reports
- S-ROM 2576-20-120TEMPLATE7 reports
- S-ROM 52-3293Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- S-ROM 52-3394Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- S-ROM 53-0300INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT7 reports
- S-ROM 87-5954Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- S-ROM 1365-17-500Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented6 reports
- S-ROM 2576-18-120TEMPLATE6 reports
- S-ROM 53-4153ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- S-ROM 87-5928TEMPLATE6 reports
- S-ROM 1365-41-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- S-ROM 2576-04-020INSTRUMENT, CUTTING, ORTHOPEDIC5 reports
- S-ROM 2576-08-000TEMPLATE5 reports
- S-ROM 2576-14-100TEMPLATE5 reports
- S-ROM 2576-22-115TEMPLATE5 reports
- S-ROM 53-4318DRIVER, PROSTHESIS5 reports
- S-ROM 87-5920TEMPLATE5 reports
- S-ROM 1365-62-500Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- S-ROM 2576-00-016EXTRACTOR4 reports
- S-ROM 2576-20-105TEMPLATE4 reports
- S-ROM 52-3207Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented4 reports
- S-ROM 52-3424Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented4 reports
- S-ROM 53-6314TEMPLATE4 reports
- S-ROM 53-6318TEMPLATE4 reports
- S-ROM 53-6320TEMPLATE4 reports
- S-ROM 1365-64-500PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- S-ROM 2365-32-500TEMPLATE3 reports
- S-ROM 2576-16-120TEMPLATE3 reports
- S-ROM 2576-17-100TEMPLATE3 reports
- S-ROM 2576-22-110TEMPLATE3 reports
- S-ROM 53-4314DRIVER, PROSTHESIS3 reports
- S-ROM 53-4316DRIVER, PROSTHESIS3 reports
- S-ROM 53-4500REXTRACTOR3 reports
- S-ROM 87-5929TEMPLATE3 reports
- S-ROM 1365-63-500Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
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 24, 2026Device Dislodged or Dislocated
It was reported that the implant was removed due to dislocation of the hip. There was no patient consequence and no surgical delay.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50886870 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829985 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50823142 ↗MalfunctionSep 16, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796499 ↗MalfunctionSep 14, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763078 ↗InjurySep 14, 2026Osseointegration Problem
It was reported that patient had pain in hip. Lucency around sleeve. There was loosening of Sleeve and stem at unknown interface with unknown cement manufacturer. Stem looked tight distal. Stem, Sleeve, Head, and Poly were removed. Reclaim Monobloc Short Stem was implanted and poly was changed to a 10 degree.Affected Side: Right Hip.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 50754173 ↗MalfunctionSep 11, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740055 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721628 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that per surgeon the patient had elevated ion levels. Surgeon changed out the metal liner for polyethylene and a new head. Date of the original surgery is unknown, but believed to be in 2007 or 2008.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Right hip.
Patient problems: Metal Related Pathology
MAUDE report 50531162 ↗MalfunctionAug 31, 2026No Apparent Adverse Event
It was reported that the device had an unknown allegation. It did not happened in surgery.During manufacturer's investigation of the returned device it was identified that the SROM SLEEVE INTRODUCER SZ 14 had signs of normal and constant usage in a clinical setting over the years; such as nick marks at the distal section, scuff marks and slight deformation at the proximal section borders.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525482 ↗MalfunctionAug 31, 2026No Apparent Adverse Event
It was reported that the device had an unknown allegation. It did not happened in surgery.During manufacturer's investigation of the returned device it was identified that the S-ROM*HEAD REMOVER had both prongs severely deformed. Additionally, the device displays an overall condition consistent with a heavy and constant usage over an extended period of time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525477 ↗InjuryAug 26, 2026Device Dislodged or Dislocated
It was reported that patient had dislocation. Tried to reduce in the ER and disassociated the head.DOI- (b)(6) 2001DOR- (b)(6) 2026Affected side- Left Hip
Patient problems: Joint Dislocation
MAUDE report 50454551 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
The patient was revised due to ongoing infection washout and removal of Emphasys DM liner and head construct consisting of an s-rom head and emphasys mb head. Replacing with the same components. No more information known.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50045929 ↗MalfunctionJul 27, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034859 ↗InjuryJul 7, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT REVISING A CONSTRAINED LINER DISLOCATION. REPLACING HEAD AND LINER DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25735059 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →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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