S-ROM ZTTRecalls & reported problems across all models
Depuy (Ireland) · 36 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 404
- Deaths reported
- 2
- Injuries reported
- 394
- Recalls
- 0
We found 36 models of S-ROM ZTT by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 404 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2014 and Sep 14, 2026 — classified as 2 deaths, 394 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (89 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 ZTT problems
Device problems
- Adverse Event Without Identified Device or Use Problem192
- Loss of Osseointegration89
- Osseointegration Problem65
- Insufficient Device Problem Information34
- Migration17
- Fracture12
- Loose or Intermittent Connection10
- Malposition of Device8
Patient problems
- Pain209
- No Code Available157
- Inadequate Osseointegration129
- Unspecified Infection99
- Discomfort66
- Foreign Body Reaction60
- Hypersensitivity/Allergic reaction32
- Tissue Damage31
S-ROM ZTT models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- S-ROM ZTT 55-0524Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented52 reports
- S-ROM ZTT 55-0523Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented31 reports
- S-ROM ZTT 55-0526Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented26 reports
- S-ROM ZTT 55-0514Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented25 reports
- S-ROM ZTT 52-1465Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented23 reports
- S-ROM ZTT 52-1483Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented22 reports
- S-ROM ZTT 55-0513Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented22 reports
- S-ROM ZTT 52-1463Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented20 reports
- S-ROM ZTT 55-0501Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented16 reports
- S-ROM ZTT 52-1485Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented15 reports
- S-ROM ZTT 55-0534Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death15 reports
- S-ROM ZTT 55-0530Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented14 reports
- S-ROM ZTT 55-0536Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented13 reports
- S-ROM ZTT 55-0533Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented11 reports
- S-ROM ZTT 55-0535Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death9 reports
- S-ROM ZTT 52-1405Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented8 reports
- S-ROM ZTT 55-0502Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented8 reports
- S-ROM ZTT 55-0525Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented8 reports
- S-ROM ZTT 52-1423Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- S-ROM ZTT 55-0504Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented7 reports
- S-ROM ZTT 52-1403Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented6 reports
- S-ROM ZTT 55-0540Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented6 reports
- S-ROM ZTT 55-0543Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented6 reports
- S-ROM ZTT 55-0503Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented5 reports
- S-ROM ZTT 55-0515Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented5 reports
- S-ROM ZTT 55-0516Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented4 reports
- S-ROM ZTT 52-1425Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- S-ROM ZTT 55-0520Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- S-ROM ZTT 55-0544Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- S-ROM ZTT 55-0570Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented3 reports
- S-ROM ZTT 55-0505Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- S-ROM ZTT 55-0550Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2 reports
- S-ROM ZTT 55-0546Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM ZTT 55-0568Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM ZTT 55-0571Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- S-ROM ZTT 55-0572Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
Recent S-ROM ZTT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 50754129 ↗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- (b)(6) 2019.DOR- (b)(6) 2026.Affected side: Left hip.
Patient problems: Inadequate Osseointegration
MAUDE report 50017177 ↗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 24790116 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR FORM METAL BEARING SURFACE. REVISION NOTES REPORTED OF SEVERE EROSIVE CHANGES AND EXTENSIVE SOFT TISSUE MASS CONSISTENT WITH PSEUDOTUMOR. THE ANTERIOR CAPSULE WAS INCISED WITH RELEASE EXTENSIVE AMOUNT OF BROWN DISCOLORED FLUID. THERE WAS ALSO SIGNIFICANT TENDINOSIS VISIBLE AND BONE EROSION. CLINICAL VISITS REPORTED OF PAIN, WEAKNESS, OSTEOLYSIS, AND BONE LOSS.
Patient problems: Arthritis; Bone Notching; Fatigue; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pocket Erosion; Swelling/ Edema
MAUDE report 23582037 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE MORE 15 YEARS AGO, THE PATIENT UNDERWENT AN INITIAL THA SURGERY WITH THE PRODUCT IN QUESTION. AFTER THE SURGERY ON (B)(6) 2025, IT WAS CONFIRMED FROM THE X-RAY OF THE CASE OF POST-THA SURGERY INFECTION THAT THE STEM WAS SROM-A AND THE CUP WAS A PRODUCT OF ANOTHER COMPANY. THE PATIENT UNDERWENT SURGERY MORE THAN 15 YEARS AGO, BUT THE EXACT DATE IS UNKNOWN. THE SECOND SURGERY IS SCHEDULED ON (B)(6) 2025 TO REMOVE THE IMPLANT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.
Patient problems: Unspecified Infection
MAUDE report 23412781 ↗InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY ON (B)(6) 2025, THE BREAKAGE OF THE STEM CALCAR WAS CONFIRMED. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Limb Fracture
MAUDE report 23074226 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 22751622 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22358398 ↗InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN (B)(6) 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.
Patient problems: Unspecified Infection
MAUDE report 22084821 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT A THA SURGERY FOR OSTEOARTHRITIS OF THE HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD A FRACTURE AND VISITED ANOTHER HOSPITAL. HOWEVER, THE PATIENT REFUSED REVISION SURGERY AND UNDERWENT CONSERVATIVE TREATMENT. AFTER THAT, THE PATIENT HAD PAIN. ON (B)(6) 2025, THE PATIENT WILL UNDERGO A REVISION THA.
Patient problems: Limb Fracture; Pain
MAUDE report 22060509 ↗InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A THA SURGERY WITH S-ROM-A IMPLANTS FOR OA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, A REVISION SURGERY DUE TO SUSPECTED TRUNIONOSIS WAS SCHEDULED FOR (B)(6)2025. ACCORDING TO THE SURGEON, THE IMAGES SHOWED A TUMOR-LIKE SUBSTANCE AROUND THE HIP JOINT. INFECTION IS ALSO SUSPECTED, BUT THIS HAS NOT BEEN CONFIRMED. IN THE REVISION SURGERY, THE HEAD, STEM, AND LINER WILL BE REMOVED, AND THEN, THE TUMOR-LIKE TISSUE WILL BE REMOVED. AFTER THAT, A NEW LINER, STEM, AND HEAD WILL BE IMPLANTED. THE CUP AND LINER THAT HAD BEEN IMPLANTED IN THE THA (INITIAL SURGERY) WERE ZIMMER BIOMET¿S PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Unspecified Infection
MAUDE report 21873211 ↗InjuryFeb 18, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A PAINFUL LEFT HIP. THERE WAS A LOOSENING REPORTED AT THE STEM AND SLEEVE AT NON CEMENTED INTERFACE. DOI: (B)(6) 2019, DOR:(B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 21400012 ↗InjuryJan 15, 2025Migration; Migration
THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT PERI-STEM FRACTURE OCCURRED AFTER A PRIMARY THA SURGERY. THIS PC REPORTS THAT DISLOCATION OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A PRIMARY THA FOR THE LEFT FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, PERI-STEM FRACTURE OCCURRED. WIRING WAS PERFORMED WITH OTHER COMPANY¿S GRIP AND CABLE IN (B)(6) 2024. ON (B)(6) 2025, THE SALES REP WAS INFORMED THAT DISLOCATION OCCURRED DUE TO STEM SINKING. ON JANUARY 7, 2025, THE SALES REP CONFIRMED THE DISLOCATION. SINCE THE PATIENT HAS A DISABILITY AND UNABLE TO COMMUNICATE, THE EVENT DATE IS UNKNOWN. THE SURGEON CANNOT GET ANY INFORMATION FROM THE PATIENT, AND EXACT TIME OF OCCURRENCE COULD NOT BE TOLD.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 21159089 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT DISLOCATION OCCURRED. THIS PC REPORTS THAT PERI-STEM FRACTURE OCCURRED AFTER A PRIMARY THA SURGERY. IT WAS REPORTED THAT ON (B)(6), 2012, THE PATIENT UNDERWENT A PRIMARY THA FOR THE LEFT FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, PERI-STEM FRACTURE OCCURRED. WIRING WAS PERFORMED WITH OTHER COMPANY¿S GRIP AND CABLE IN (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Limb Fracture
MAUDE report 21159024 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITIGATION COMPLAINT RECEIVED: THE PATIENT SUFFERED PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT. SEVERE AND DEBILITATING PAIN AND WEAKNESS; SIGNIFICANT INHIBITIONS OF HIS ABILITY TO WALK OR MOVE; METALLOSIS, ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT; ANXIETY, FEAR, MENTAL ANGUISH AND OTHER EMOTIONAL AND PHYSICAL DAMAGES. AFFECTED SITE: RIGHT HIP.
Patient problems: Ambulation or Postural Difficulties; Anxiety; Distress; Emotional Changes; Fatigue; Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 21136864 ↗
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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