S-ROM ZTT 55-0526Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295175315), received between Nov 9, 2017 and Jan 13, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 26 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP INFECTION. THE IMPLANTS WERE EXPLANTED AND AN ANTIBIOTIC PROSTALAC SPACER WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17556190 ↗
• InjuryMay 9, 2022Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. DATE OF IMPLANT: (B)(6) 2015. DATE OF REVISION: (B)(6) 2019. (RIGHT HIP). FEMORAL STEM AND FEMORAL HEAD REVISED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14336419 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE LOCAL TISSUE REACTION - HIGH COBALT BLOOD LEVELS. EVENT IS NOT SERIOUS AND IS CONSIDERED. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005; DATE OF EVENT (ONSET): (B)(6) 2021; (LEFT HIP). TREATMENT: REVISION OF THE HEAD AND LINER.

  Patient problems: Foreign Body Reaction; Scar Tissue; Swelling/ Edema

  MAUDE report 13505155 ↗
• InjuryOct 4, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12568404 ↗
• InjuryAug 24, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2003, DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12360936 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS PROSTALAC DUE TO INFECTION. SROM AND COMPETITORS CUP CONSTRUCT REMOVED AND REPLACED WITH A PROSTALAC. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11342560 ↗
• InjuryApr 7, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD STIFFNESS, AND FULLNESS IN THE LEFT HIP REGION AS WELL AS A SMALL PSEUDOTUMOR. THE 40MM METAL ON METAL LINER AND 40MM HEAD ALONG WITH THE STEM WERE REMOVED AND REPLACED WITH 36/60 NEUTRAL LINER AND A NEW STEM AND 36MM DELTA 11/13 SROM HEAD WAS IMPLANTED. THE PATIENT REQUESTED ALL REMOVED IMPLANTS TO BE RETURNED TO HIM. DOI: (B)(6) 2008; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; Nausea; No Code Available; Pain

  MAUDE report 9933160 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, WEAKNESS, DIFFICULTY WITH DAILY LIVING ACTIVITIES AND INCREASED METAL IONS IN HIS BLOOD STREAM DUE TO THE IMPLANTED ASR HIP. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP). PT IS A RESIDENT OF THE STATE OF (B)(6). UPDATE: 3/26/13 - ASR/SUPPLEMENTAL INFORMATION RECEIVED. PART/LOT HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE AD 13 NOV 2018: WPC 620-2013 HAS BEEN RE-OPENED UNDER (B)(4) BECAUSE OF A NEW ALERT RECEIVED. IN ADDITION TO WHAT WERE PREVIOUS ALLEGED, LITIGATION ALLEGES INJURY AND EMOTIONAL DISTRESS. DOR: (B)(6) 2018.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result; Weakness

  MAUDE report 9823738 ↗
• InjuryMar 5, 2020Corroded; Degraded; Corroded; Degraded

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, PAIN, ALVAL LESION AND OSTEOLYSIS. INTRAOPERATIVELY, THERE WAS A DARK, BLACKISH FLUID, BONE LOSS, MINOR CORROSION OUTSIDE OF THE MORSE TAPER AREA AND OSTEOLYSIS. OSTEOMYELITIS WAS NOTED TO BE PRESENT ON THE PROXIMAL FEMUR. STEM AND ACETABULAR COMPONENTS WERE NOTED TO BE WELL FIXED. THERE WAS QUITE A BIT OF PROXIMAL FEMORAL OSTEOCLASIS WHICH EXPOSED MAJORITY OF THE ANTERIOR PORTION OF THE SLEEVE. DESPITE THIS, THE IMPLANT REMAINED WELL FIXED. RIGHT HIP REVISION INDICATES THAT THE PATIENT HAD UNDERGONE THE LEFT HIP REVISION DUE TO ELEVATED METAL ION LEVELS. PRIMARY SURGERY NOTES INDICATE THAT DURING THE FINAL IMPACTION OF THE FEMORAL SLEEVE, THERE WAS A SLIGHT CALCAR CRACK. A CERCLAGE WIRE WAS PLACED AROUND THE CRACK. DOI: (B)(6) 2005; DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Bone Fracture(s); Edema; Foreign Body Reaction; No Code Available; Osteolysis; Pain; Unspecified Infection

  MAUDE report 9794544 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURALOC SHELL/ LINER AND SROM STEM/ HEAD WERE REMOVED FOR INFECTION AND CHRONIC DISLOCATION. STEM AND SHELL IMPLANTATION DATE ARE UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9749959 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGED NUMBNESS IN LEGS AND FEET AFTER FIRST REVISION. ADDED CUP, APEX HOLE ELIMINATOR AND SLEEVE TO CAPTURE THE ALLEGATION. DOI: (B)(6) 2017 (LINER & HEAD); DOI: (B)(6) 2009 (CUP, APEX & SLEEVE); DOR: NONE REPORTED LEFT HIP.

  Patient problems: Hypoesthesia; No Code Available

  MAUDE report 9617736 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, STICKER SHEETS, IMPLANT RECORDS RECEIVED. PPF ALLEGES STROKE AND HEART ATTACK. DOI: (B)(6) 2013 - DOR: NONE REPORTED (RIGHT HIP). DOI: (B)(6) 2005(STEM, SLEEVE, AND APEX HOLE ELIMINATOR). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Cardiac Arrest; Infarction, Cerebral

  MAUDE report 8983360 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SMALL CALCAR FRACTURE : PERIPROSTHETIC FRACTURE - FEMORAL EVENT IS SERIOUS AND IS CONSIDERED MILD EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 8897488 ↗
• InjuryJul 2, 2019Loss of Osseointegration; Loss of Osseointegration

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT HIP REVISION TO ADDRESS ASEPTIC LOOSENING OF THE STEM. DOI: (B)(6) 2008; DOR: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8754057 ↗
• InjuryMay 20, 2019Fracture; Fracture

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FOR PERIPROSTHETIC FEMUR FRACTURE.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 8623268 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES LIMITED MOBILITY AND DIFFICULTY WALKING. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTE REPORTED THAT THE TISSUE WAS CONSISTENT WITH AN INFLAMMATORY REACTION TO THE METAL AND THERE WAS SOME MILD CORROSION ON THE FEMORAL NECK. IT WAS ALSO MENTION IN THE OPERATIVE NOTE THAT THERE WAS NO EVIDENCE OF TISSUE DAMAGE OR INFLAMMATION AND NO METAL STAINING IN THE TISSUE. CLINICAL NOTE REPORTED MRI SHOWED COBALT CHROMIUM LEVELS WERE MILDLY ELEVATED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8526966 ↗
• InjuryMar 26, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  UPDATE AD 17 JUL AND 07 AUG 2018: PPF ALLEGES LOOSENING OF STEM, METAL WEAR AND METALLOSIS. ADDED STEM AND SLEEVE DUE TO ALLEGED LOOSENING OF STEM.

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

  MAUDE report 8452247 ↗
• InjuryMar 19, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LITIGATION ALLEGES LOOSENING OF STEM, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Tissue Damage

  MAUDE report 8432819 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT WAS REVISED DUE TO PAIN AND DISCOMFORT. UPDATE JUN 27, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY LITIGATED, PATIENT ALSO ALLEGES LIMITED MOVEMENT, HIGH LEVELS OF EMOTIONAL DISTRESS AND ANXIETY. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INCREASING HIP PAIN AND FAILED RIGHT TOTAL HIP ARTHROPLASTY. ON THE OPERATIVE NOTE IT WAS REPORTED THAT THE SERUM INFECTION MARKERS INCLUDING CBC WITH DIFFERENTIAL, ESR AND C-REACTIVE PROTEIN ARE ALL WITHIN NORMAL LIMITS. MRI OF THE RIGHT HIP SHOWS A SMALL FLUID COLLECTION, WHICH REPRESENT A SMALL PSEUDOTUMOR.

  Patient problems: Anxiety; Discomfort; No Code Available; Pain; Pulmonary Embolism; Tissue Damage

  MAUDE report 8280923 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT COMPLAINED THE PAIN AFTER ABOUT 1 YEAR FROM THE PRIMARY SURGERY. THE SURGEON RECOGNIZED THAT THERE WAS VARUS TENDENCY AND SKIN THINNING TENDENCY. THE PATIENT WAS UNDER OBSERVATION, BUT IT WAS REPORTED THAT THERE WAS A POSSIBILITY OF THE REVISION SURGERY TO BE PERFORMED BY REPLACING THE CUPS, THE LINERS, THE HEADS AND THE STEMS FROM THE PATIENT¿S BOTH SIDE HIP JOINT. (DATE OF REVISION SURGERY WAS NOT FIXED YET).

  Patient problems: Pain

  MAUDE report 8270106 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8257085 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS THIGH PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8210250 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR, STROKE/HEART ATTACK, LOOSENING OF STEM, AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2007 - DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Infarction, Cerebral; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8189717 ↗
• InjuryJan 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINIAL DER STATES AE RECEIVED FOR INTRAOPERATIVE COMPLICATION OF FEMORAL BONE FRACTURE. EVENT DOES NOT MEET THE DEFINITION OF SERIOUS. EVENT HAS A REMOTE POSSIBILITY OF BEING RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. TREATMENT INCLUDES ORIF WITH WIRE FIXATION. DOE: (B)(6) 2017. THERE IS A SURGICAL DELAY. RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 7192877 ↗