S-ROM ZTT 52-1465Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295170624), received between Oct 26, 2017 and Oct 25, 2023 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS HAVING A REVISION SURGERY FOR SUSPECTED PSEUDOTUMOR RELATED TO METAL ON METAL IMPLANTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PSEUDO TUMOUR, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: REVISION SURGERY REQUIRED , IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18004708 ↗
• MalfunctionAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SLEEVE IS FRACTURED.

  Patient problems: Fall; Pain

  MAUDE report 17585553 ↗
• InjuryJan 6, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AND SLEEVE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13175607 ↗
• InjuryOct 26, 2021Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THIS PC REPORTS ABOUT THE EVENT OCCURRED IN THE SECOND REVISION SURGERY ON (B)(6) 2021. LOOSENING OF IMPLANTS OCCURRED AFTER THE PRIMARY THA SURGERY AND THE FIRST REVISION SURGERY WAS PERFORMED. AFTER THE FIRST REVISION SURGERY, INFECTION OCCURRED, AND THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. IN THE SECOND REVISION SURGERY, THE SURGEON TRIED TO DISASSEMBLE THE STEM FROM THE SLEEVE TO REMOVE THEM, BUT HE COULDN¿T. THE SURGEON UNAVOIDABLY REAMED THE BONE AROUND THE STEM WITH A CHISEL AND REMOVED THE STEM AND THE SLEEVE INTEGRATED BY USING A SLIDE HAMMER. THEN, AN IMPLANT (ZIMMER BIOMET¿S PRODUCT) ON THE ACETABULAR SIDE WAS REMOVED, AND AFTER CAREFUL CLEANING, A CEMENT SPACER CONTAINING ANTIBIOTICS WAS PLACED IN THE JOINT SPACE. THE SECOND REVISION SURGERY WAS COMPLETED WITH 60 MINUTES DELAY. BECAUSE THE STEM AND SLEEVE COULD NOT BE SEPARATED AT THE TIME OF REMOVAL, THE DAMAGE TO THE FEMUR INCREASED. IN THE FUTURE, THE THIRD REVISION WILL BE PERFORMED IF POSSIBLE WHILE MONITORING THE PATIENT'S COURSE. THE SURGEON WANTS US TO IDENTIFY THE CAUSE OF THE FAILURE TO SEPARATE THE STEM FROM THE SLEEVE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12699390 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION LITIGATION RECORDS RECEIVED. RECORDS ALLEGES PAIN, INJURY, ECONOMIC LOSS, WALKING DIFFICULTY AND EXCESSIVE COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2008, DOR: (B)(6)2019, RIGHT HIP. MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METALLOSIS. OPERATIVE NOTES INDICATED IN MRI SHOWS SOME DIFFUSE SYNOVITIS. UPON OPENING THE CAPSULE THERE WAS SOME FLUID PRESSURE THAT APPEARS MORE MILKY. THERE WAS A LOT OF STAINING OF THE TRUNNION AND A LITTLE BIT PITTING.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11847970 ↗
• InjuryMay 4, 2021Migration; Migration

  IT WAS REPORTED THAT DR PERFORMED THE PATIENTS INITIAL SURGERY ON (B)(6) 2009. PATIENT WAS COMPLAINING OF SOME THIGH PAINS. WHEN LOOKING AT THE X-RAY, DR K NOTICED THAT STEM APPEARED TO HAVE SHIFTED INTO VARUS. HE DECIDED THIS COULD BE THE CAUSE FOR HER DISCOMFORT AND FELT SHE WOULD BENEFIT FROM A REMOVAL OF THE SROM STEM. THE FEMORAL HEAD AND STEM WERE REMOVED AS WELL AS THE ACETABULAR LINER. HE IMPLANTED A COMPETITOR STEM WITH THEIR 32MM HEAD. A NEW LINER WAS IMPLANTED FOR THE PINNACLE CUP AND A TRIAL REDUCTION WAS PERFORMED. HIP WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2009; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Discomfort; Pain

  MAUDE report 11771338 ↗
• MalfunctionApr 21, 2021Difficult to Remove; Difficult to Remove

  ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED. IN THE REVISION, AFTER THE HEAD WAS REMOVED, THE SURGEON TRIED TO REMOVE THE STEM, BUT THE STEM COULDN¿T BE REMOVED, AND IT WAS LEFT IN THE PATIENT. THE NON-DEPUY IMPLANTS WERE SET, AND THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. THE SURGEON COMMENTED THAT THE COLD WELDING OCCURRED BETWEEN THE STEM AND SLEEVE AND THE WORKING SPACE WAS NARROW, AND HE GAVE UP USING THE SCHNEIDER CAGE DUE TO THIS REASON.

  Patient problems: Insufficient Information

  MAUDE report 11703897 ↗
• InjuryFeb 12, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS ADMITTED DUE TO PAIN AND WAS FOUND TO HAD DEVELOPED POST-OP INFECTION. IRRIGATION AND DEBRIDEMENT PLUS IV ANTIBIOTIC TREATMENT DONE ON (B)(6) 2008. SUBSEQUENTLY, REVISION WAS MADE ON (B)(6) 2008. REVISION NOTES REPORTED PURULENCE BETWEEN THE LINER AND SHELL. THE ACETABULUM WAS ALSO FOUND TO BE LOOSE WITHOUT OSTEAL INTEGRATION. THE RIGHT HIP AREA WAS SWOLLEN AND REDDENED. RE-REVISION DONE ON (B)(6) 2009 TO REMOVE THE NON-ARTICULATING ANTIBIOTIC SPACER AND IMPLANTATION OF DEFINITIVE IMPLANTS; NON-DEPUY DEVICES WERE USED. MOREOVER, DURING THE INITIAL HIP REPLACEMENT ON (B)(6) 2007, THE SROM STEM AND SLEEVE WERE TOO TIGHT IN THE BONE SO THE SROM STEM BACKED OUT AND FEMUR OVER REAMED TO 12MM. A CABLE WAS USED TO AVOID INSERTIONAL FRACTURE. IN THIS COURSE, IT RESULTED TO POSTERIOR AVULSION OF THE GREATER TROCHANTER. LATER ON (B)(6) 2007, AN I&D AND EVACUATION OF HEMATOMA WAS DONE AND THE AVULSION WAS REPAIRED. DOI: (B)(6) 2007 (CUP, LINER, SLEEVE, SCREWS); DOI: (B)(6) 2008 (HEAD, STEM). DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Edema; Hematoma; No Code Available; Pain; Unspecified Infection

  MAUDE report 9700093 ↗
• InjuryFeb 4, 2020Migration; Migration

  IT WAS REPORTED THAT THE CUP AND LINER WERE REMOVED DUE TO POOR POSITIONING. THE STEM, SLEEVE AND HEAD WERE REMOVED DUE TO SUBSIDENCE. DOI: (B)(6) 2016; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9664996 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INJURIES DUE TO ELEVATED METAL IONS RESULTING TO PAIN, SUFFERING AND EMOTIONAL DISTRESS. PLAINTIFF IS SEEKING COMPENSATORY DAMAGES.

  Patient problems: Distress; No Code Available; Pain

  MAUDE report 9437289 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. PFS ALLEGE PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8616866 ↗
• InjuryMay 8, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PATIENT SUFFERS FROM TOXIC COBALT-CHROMIUM METAL IONS, PAIN, DISCOMFORT, AND INFLAMMATION. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2002 - DOR: (B)(6) 2004, (LEFT HIP).

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

  MAUDE report 8590817 ↗
• InjuryApr 11, 2019Migration; Migration

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN, ADHESIVE CAPSULITIS AND POLY WEAR. IT WAS ALSO STATED THAT THAT THE ANERVERSION OF THE STEM WAS CHANGED TO SLIGHTLY ANTEVERTING. THERE IS NO SIGNS OF LOOSENING BUT IT LOOKED LIKE THE Z-CONE HAD SUBSIDED. THE POLY APPEARED TO BE WEAR. PATIENT HAD DISLOCATED OUT THE FRONT THE FIRST TIME SLIGHTLY OVER RETROVERTED HER AND SO DECIDED TO DISLODGE THE SROM STEM AND THEN RE-IMPACTED IT IN ABOUT PROBABLY 5 TO 10 DEGREES OF MORE ANTEVERSION. UPDATED PRODUCT CODES AND LOT NUMBERS.

  Patient problems: No Code Available; Pain

  MAUDE report 8505450 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND A BROKEN RING ON THE CONSTRAINED LINER. PPF ALLEGES CONSTRAINED LINER, AND DISLOCATION WITH OPEN AND CLOSED REDUCTION. DOR: (B)(6) 2009 - DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8503251 ↗
• InjuryMar 1, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2012 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8381735 ↗
• InjuryJan 29, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM INFLAMMATION, DISCOMFORT, AND LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE THE REVISION OPERATIVE NOTE INDICATED INSTABILITY, PSEUDOTUMOR, METAL DEBRIS, DISLOCATION, DISSOLUTION OF THE GREATER TROCHANTER. UPDATE THE MEDICAL RECORDS AND REVISION SURGICAL REPORT INDICATED PSEUDOTUMOR, LOSS OF ABDUCTOR MUSCLE, INSTABILITY, DISLOCATION, COMPLETE LOSS OF GREATER TROCHANTER, THE ACETABULAR COMPARTMENT QUITE VERTICAL BUT NOT REVISED, MYOSITIS OSSIFICATIONS OF LEFT GLUTEUS MEDIUS MYOTENDINOUS JUNCTION AND SERUM COBALT LEVEL OF 70. UPDATE PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, DISLOCATION WITH CLOSED REDUCTION, LOOSENING OF STEM, METAL WEAR, AND METALLOSIS. DOI: (B)(6) 2005 - DOR: (B)(6) 2010 (LEFT HIP).

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

  MAUDE report 8285592 ↗
• InjuryJan 28, 2019Loose or Intermittent Connection; Osseointegration Problem; Loose or Intermittent Connection; Osseointegration Problem

  LITIGATION ALLEGES LOOSENING. DOI: (B)(6) 2007 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8281313 ↗
• InjuryJan 18, 2019Loss of Osseointegration; Loss of Osseointegration

  IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE STEM.

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

  MAUDE report 8260266 ↗
• InjuryNov 14, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE AD 30 APR 2018: RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE STEM. ADDED PATIENT'S DOB, LAWYER, FACILITY NAME, ACCOUNT NAME, REVISION SURGEON, PATIENT HARMS AND PRODUCT DETAILS OF HEAD AND LINER. ADDED STEM DUE TO THE ALLEGED LOOSENING OF STEM.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8068739 ↗
• InjuryJul 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT HAD FEMORAL FRACTURE, 4 MTHS POST IMPLANTATION. ALL COMPONENTS WERE REMOVED AND AN IMPLANT FROM ANOTHER COMPANY USED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Not Applicable

  MAUDE report 7721814 ↗
• InjuryJun 21, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED BECAUSE OF PAIN AND LYSIS. DOI: (B)(6) 2003 DOR: (B)(6) 2010. UPDATE 07/28/2011 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. PATIENT IS A RESIDENT (B)(6). UPDATE 11/18/2012 - PATIENT'S MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THE COMPLAINT HAS BEEN REOPENED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. ADDITIONAL MEDICAL RECORDS ARE AVAILABLE ON THE EXTERNAL HARD DRIVE IF NEEDED. UPDATE AD 23 MAY 2018 (B)(4) IS REOPENED UNDER (B)(4)DUE TO RECEIPT OF PPF AND IMPLANT STICKER SHEET RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES LOOSENING OF THE CUP AND STEM, BONE AND IMPLANT FRACTURE, METAL WEAR AND METALLOSIS, AND ELEVATED METAL IONS. THE LAWYER AND FIRM HAS BEEN UPDATED. THE CUP, HEAD, STEM, AND SLEEVE HAS BEEN ADDED IN IP'S. DOI: (B)(6) 2003; DOR: (B)(6) 2010; LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Not Applicable; Osteolysis; Pain; Tissue Damage

  MAUDE report 7624568 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE PPF RECEIVED. PPF ALLEGES STROKE AND HEART ATTACK. DOI: (B)(6) 2017; DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral

  MAUDE report 7597884 ↗
• InjuryOct 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT HAD PREVIOUS SUBTROCHANTERIC FRACTURE THAT HAS NOT FULLY HEALED. IT WAS ALSO REPORTED THAT THE HIP IS PAINFUL.

  Patient problems: Pain

  MAUDE report 6979095 ↗