S-ROM ZTT 55-0523Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295175285), received between Jan 9, 2014 and Oct 14, 2024 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT THE STUDY PATIENT UNDERWENT SURGERY FOR THE LEFT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE: DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: AUGUST 20, 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 20438317 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTE AD 14 OCT 2024 WAS REVIEWED BY A CLINICIAN. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT THA DUE TO INCREASING PAIN AND DIFFICULTY WALKING. POST-OPERATIVELY THE PATIENT SUSTAINED AN ACUTE PE IN THE RIGHT LOWER LOBE. SHE WAS TREATED WITH A HEPARIN DRIP. SHE ALSO HAD A NON-OCCLUSIVE DVT IN THE LEFT LEG. THIS WAS LIKELY THE ORIGINAL CLOT FROM THE PE. SHE WENT INTO OBSTRUCTIVE SHOCK FROM THE PE REQUIRING NOREPINEPHRINE IN THE ICU. SHE WAS ALSO DIAGNOSED WITH ENCEPHALOPATHY, ACUTE HYPERCAPNIC AND HYPOXEMIC RESPIRATORY FAILURE, HYPONATREMIA, AND AN ACUTE KIDNEY INJURY. PMH INCLUDES CHF, HYPOTHYROIDISM, MORBID OBESITY, ADHD, AND OBSTRUCTIVE SLEEP APNEA. PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 WITH HOME HEALTH SERVICES.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Pulmonary Embolism; Renal Impairment; Respiratory Failure; Thrombosis/Thrombus

  MAUDE report 20325055 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: (B)(6) 2024 (RIGHT HIP) TREATMENT: OPEN REDUCTION INTERNAL FIXATION

  Patient problems: Limb Fracture

  MAUDE report 19142450 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SROM STEM WAS TAKEN OUT, THE CUP LINER WAS REPLACED WITH SAME SIZE THAT WAS PUT IN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 17650660 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT HIP. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16776805 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE PAIN, INJURY, AND ELEVATED METAL IONS. UPDATE REC'D (B)(6) 2015 PARTIAL MEDICAL RECORDS RECEIVED. PATIENT REPORTED TO HAVE LOW METAL ION LEVELS OF CO 1 AND CR 1.1. PATIENT WAS ADMITTED FOR REVISION TO ADDRESS DISCOMFORT, OSTEOLYSIS AND DISABILITY. COMPLETE REVISION PROCEDURE REPORTS WERE NOT RECEIVED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON (B)(6) 2015. UPDATED REC'D (B)(6) 2016 SUPPLEMENTAL RECEIVED. PART AND LOT INFORMATION WAS PROVIDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. COMPLAINT WAS UPDATED (B)(6) 2016 UPDATE AD (B)(6) 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO MEDICAL RECORDS AND STICKER SHEETS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO PAINFUL THA OF LEFT HIP, MECHANICAL COMPLICATION AND METAL DEBRIS INDUCED SYNOVITIS, HIP EFFUSION AND OSTEOLYSIS OF THE FEMUR. OPERATIVE NOTE REPORTED A LARGE AMOUNT OF BROWNISH COLORED FLUID, THERE IS A MILD AMOUNT OF CORROSION UNDER THE TAPER, FIBRINOUS BROWN MATERIAL IN THE JOINT WITH DEBRIS AND BROWNISH STAINED SYNOVIUM, LYSIS IN THE GREATER TROCHANTER AND MISSING BONE. OPERATIVE FINDING RE

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Discomfort; Distress; Emotional Changes; Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 15638791 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT WAS DIAGNOSED WITH DENSE FIBROUS TISSUE AND FOCAL SYNOVIUM WITH FOCI OF DEGENERATION, HEMORRHAGE, MILD CHRONIC LYMPHOHISTIOCYTIC INFLAMMATION, HEMOSIDEROSIS, METALLOSIS, RARE FOREIGN BODY GIANT CELLS, AND ABUNDANT FIBRIN OF THE RIGHT HIP BONE AND TISSUE. DOI: (B)(6) 2018, DOR: NOT REPORTED, RIGHT HIP. (B)(4) FIRST REVISION. (B)(4) SECOND REVISION. (B)(4) THIRD REVISION.

  Patient problems: Foreign Body Reaction; Impaired Healing; Necrosis; Osteolysis; Pain; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 14336241 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CAN YOU PLEASE CLARIFY IF THE FRACTURE WAS ON THE BONE OR ON THE IMPLANT? IF BONE, PLEASE CONFIRM THE LOCATION OF BONE FRACTURE, WAS IT THE ACETABULAR SIDE OR FEMORAL SIDE? ANSWER: FEMORAL BONE.

  Patient problems: Insufficient Information; Limb Fracture

  MAUDE report 11632058 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, IMPLANTED A PROSTALAC STEM. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10621908 ↗
• MalfunctionAug 6, 2020Fracture; Fracture

  CLINICAL ADVERSE EVENT RECEIVED FOR IMPLANT FRACTURE - S-ROM STEM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. (RIGHT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 10376120 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASSOCIATED STUDY: REGISTRY, DATE OF EVALUATION: (B)(6) 2020, DATE OF ONSET: (B)(6) 2020, DIAGNOSIS: LT THIGH PAIN, ADVERSE EVENT: MUSCULOSKELETAL.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); No Code Available; Pain

  MAUDE report 10346955 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT COMPLAINS OF PROGRESSIVE PAIN AND UNDERWENT A PRIOR REPORTED HEMATOMA DEBRIDEMENT FOR A SUSPECTED QUADRICEPS TEAR. THE PATIENT PRESENTED WITH A PSEUDOTUMOR AND CONCERN FOR METALOSIS FROM HIS METAL ON METAL HIP AND WAS THEN REVISED FOR LEFT TOTAL HIP METAL ON METAL WEAR WITH PSEUDOTUMOR. OPERATIVE NOTES REPORTED THAT THERE WAS A CONSIDERABLE AMOUNT OF HEMATOMA WAS IDENTIFIED. THE ABDUCTORS WERE ATTENUATED BUT NOT GROSSLY COMPROMISED. THE FEMORAL HEAD WAS REMOVED AND TRUNNIONOSIS WAS NOTED. INTRAOPERATIVE PATHOLOGY DOCUMENTED POSITIVE FROZEN SPECIMENS, WHICH WAS PRESENT IN THE TISSUE SENT AT THE BEGINNING OF THE CASE. PATHOLOGY REPORT NOT PROVIDED. DOI: (B)(6) 2007; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9865679 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED LEFT TOTAL HIP METAL ON METAL ARTHROPLASTY WITH METALLOSIS AND PSEUDOTUMOR FORMATION. INTRAOPERATIVELY, CLEAR FLUID WAS SUCTIONED FROM THE JOINT. BLACK AND GREY METALLOSIS TISSUE WAS NOTED AROUND THE FEMORAL STEM AND CUP. THERE WAS NO OBVIOUS SIGN OF INFECTION. BOTH THE STEM AND CUP HAD NO SIGNS OF LOOSENING. THERE WAS NO EVIDENCE OF TRUNNION WEAR OR METALLOSIS INSIDE THE HEAD. ESTIMATED BLOOD LOSS WAS GREATER THAN 1000CC. PATIENT WAS GIVEN 1 UNIT OF PACKED RED BLOOD CELLS. DOI: (B)(6) 2010; DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Edema; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 9776449 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) HAS INDICATED THAT AFTER THE REVISION, THE PATIENT HAS NOTED A LEG LENGTH DISCREPANCY AND PAIN. THE MEDICAL RECORDS BELIEVE THE PAIN CAN BE ATTRIBUTED TO POSSIBLE LYMPHOMA. IN ADDITION PPF ALLEGES ELEVATED METAL IONS AFTER 1ST REVISION. DOI: (B)(6) 2014; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Pain

  MAUDE report 9395656 ↗
• InjuryMay 1, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES INFECTION, LOOSENING OF STEM AND ELEVATED METAL IONS. DOI: (B)(6) 2011, DOR: (B)(6) 2015, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain; Unspecified Infection

  MAUDE report 8568539 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PFS AND MEDICAL RECORDS RECEIVED. LAB VALUES INDICATE ELEVATED METAL ION LEVELS POST REVISION. NO SECOND REVISION HAS BEEN PROVIDED. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES PULMONARY EMBOLISM AFTER THE FIRST REVISION. DOI: (B)(6) 2015 - DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8535249 ↗
• InjuryApr 17, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES LOOSENING OF THE STEM AND SLEEVE. DOI: (B)(6) 2004 (STEM AND SLEEVE). DOI: (B)(6) 2012 (HOLE ELIM, HEAD AND LINER). DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Loss of Range of Motion; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8522301 ↗
• InjuryApr 11, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR, DISLOCATION WITH OPEN AND CLOSED REDUCTION AND LOOSENING OF STEM. DOI: (B)(6) 2004; DOR: (B)(6) 2006, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Tissue Damage

  MAUDE report 8505687 ↗
• InjuryApr 9, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE 6/1/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, A PRE-OPERATIVE REVISION NOTE INDICATED PAIN AND POSSIBLE CUP LOOSENING. NO REVISION NOTE WAS PROVIDED SO THE LOOSENING WAS NEVER CONFIRMED. NO LOOSENING WAS ALLEGED FOR LITIGATION. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. UPDATE AD 25 JUL 2018 RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM AND ABDUCTOR MUSCLE REPAIR.

  Patient problems: Discomfort; No Code Available; Pain; Tissue Damage

  MAUDE report 8495040 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS CUP LOOSENING AND A BROKEN SCREW. RETRIEVING THE SCREW DELAYED SURGERY ONE HOUR. UPDATE AD 10 JUL 2018: PPF ALLEGES, LOOSENING OF THE CUP, DISLOCATION AND INFECTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8424510 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. DOI: (B)(6) 2008 - DOR: (B)(6) 2008 (LEFT HIP).

  Patient problems: Inflammation; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection

  MAUDE report 8260186 ↗
• InjuryDec 19, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, AND DIFFICULTY WALKING OR SITTING FOR EXTENDED PERIODS. PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2006 - DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8179046 ↗
• InjuryNov 16, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE AD 1 MAY 2018 IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2012 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available; Pain; Weakness

  MAUDE report 8077398 ↗
• InjuryAug 1, 2018Fracture; Fracture

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ACETABULAR AND CALCAR FRACTURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2018; (RIGHT, HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 7739023 ↗
• InjuryJun 26, 2018Fracture; Fracture

  PINNACLE INDEX PROCEDURE. UNKNOWN HIP. REASON FOR REVISION: UNKNOWN. DOI: (B)(6) 2008; DOR: NOT REVISED (UNKNOWN HIP). NOTE: REQUEST FOR SUPPLY DATES ONLY AND NO DATES OF REVISION THEREFORE, A PATIENT CONSENT FORM DOES NOT NEED TO BE SENT OUT.

  Patient problems: No Code Available

  MAUDE report 7638378 ↗