S-ROM ZTT 52-1463Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295170617), received between Apr 3, 2018 and Jan 10, 2022 — classified as 20 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THA SURGERY 15 YEARS AGO. FOLLOWING SURGERY, PATIENT COMPLAINED OF PAIN. UPON INVESTIGATION, IT WAS CONFIRMED A PERIPROSTHETIC JOINT INFECTION HAD DEVELOPED. REVISION WAS COMPLETED TO ADDRESS THE ISSUE. IMPLANTS WERE REMOVED AND AFFECTED AREA WAS TREATED WITH ANTIBIOTICS. IMPLANTATION OF NEW IMPLANTS WILL OCCUR ONCE INFECTION SUBSIDES.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13215727 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE TKA SURGERY WITH IMPLANTS IN QUESTION DUE TO NON-UNION AFTER THE CHS SURGERY. THE DETAILS OF CHS SURGERY ARE UNKNOWN, AND THE IMPLANTS WERE ANOTHER COMPANY'S PRODUCTS. AFTER THE THA SURGERY, INFECTION OCCURRED. THE PATIENT WAS FOLLOWED UP, BUT PUS SPURTED OUT, SO THE TKA REMOVAL SURGERY (LT-HIP) WAS PERFORMED ON (B)(6) 2021, DUE TO INFECTION. IN THE REMOVAL SURGERY, THE PATIENT UNDERWENT DEBRIDEMENT AND GIRDLESTONE OPERATION. THE SURGEON COMMENTED THAT THE RISK OF INFECTION MIGHT BE HIGH BECAUSE THA WAS PERFORMED AFTER NON-UNION. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014; DOR: (B)(6) 2021; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13017676 ↗
• InjurySep 23, 2021Degraded; Degraded

  (B)(4). LITIGATION PAPERS ALLEGE PAIN AND DISCOMFORT IN HER LEFT HIP CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES, DIMINUTION IN EARNING CAPACITY, LOST WAGES, MEDICAL MONITORING EXPENSES, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, METALLOSIS EXPOSURE AND OTHER INJURIES PRESENTLY UNDIAGNOSED. FURTHER ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP) PATIENT IS RESIDENT OF (B)(6). UPDATE: 12/6/2011 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(6) 2011. THERE WAS NO NEW INFORMATION RECEIVED THAT WOULD IMPACT THE OUTCOME OF THE INVESTIGATION. UPDATE AD 19 JUN 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE ASR PLAINTIFF DISCLOSURE FORM RECORDS RECEIVED. PDF INDICATED THAT THE PATIENT HAD UNDERWENT REVISION SURGERY. REPORTED REVISION DATE. DOI: (B)(6) 2008. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Limb Fracture; Loss of Range of Motion; Muscular Rigidity; Pain; Physical Asymmetry

  MAUDE report 12518571 ↗
• InjuryApr 14, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR LEFT WITH THE IMPLANTS. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. IT SEEMED THAT THERE WAS A PSEUDOTUMOR. IN THE REVISION, THE IMPLANTS WERE REPLACED WITH NEW IMPLANTS. THE DETAILS OF THE IMPLANTS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration

  MAUDE report 11664450 ↗
• InjuryApr 1, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. AFTER LOOKING AT X-RAY AND MRI, THE SURGEON SAW THAT THE STEM MAY BE LOOSE. ONCE WE GOT IN THE OR, THE STEM WAS VERY DIFFICULT TO SEPARATE THE STEM FROM THE SLEEVE, THE SURGEON HAD TO USE A METAL CUTTING BURR TO GET IT TO SEPARATE. AFTER STEM AND SLEEVE WERE REMOVED, HE REPLACED WITH A RECLAIM MODULAR STEM. DOI: (B)(6) 2018. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11601828 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: ON (B)(6) 2013. PATIENT RECEIVED A RIGHT PRIMARY DEPUY TOTAL HIP TO TREAT CHRONIC PAIN AND IMMOBILITY SECONDARY TO SEVERE END-STAGE OSTEOARTHRITIS AND CHRONIC ALCOHOLISM. UPON ENTERING THE JOINT, THE SURGEON NOTES THE PATIENT HAD COMPLETE EROSION OF THE FEMORAL HEAD AND SUPERIOR ACETABULAR WALL REQUIRING A COMPLETE RECONSTRUCTION OF THE JOINT UTILIZING AN ACETABULAR RECONSTRUCTION CAGE AND CEMENTED STEM/SLEEVE COMBINATION UTILIZING DEPUY CEMENT X 2. THE PATIENT ALSO REQUIRED BONE GRAFTING WITH COMPETITOR CORTICOCANCELLOUS BONE. THE SURGEON NOTES THE PATIENT HAS GRADE IV DYSPLASTIC DISLOCATION. THE THA RECONSTRUCTION WAS NOTED TO BE VERY COMPLEX DUE TO THE SEVERITY OF THE NATURAL BONE LOSS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. OF NOTE, THE PATIENT WAS SEVERELY DISABLED, AND WHEELCHAIR BOUND BEFORE THE PROCEDURE. FOLLOWING THE HIP RECONSTRUCTION, THE PATIENT WAS ABLE TO RESUME LIMITED ADLS AND MOBILITY WITH THE USE OF A WALKER. CLINIC NOTE DATED ON (B)(6) 2020. PATIENT PRESENTS WITH INTERMITTENT RIGHT HIP SWELLING AND HEMATOMA SECONDARY TO A TROCHANTER FRACTURE. X-RAYS REVEAL A NEW GREATER TROCHANTER FRACTURE ASSOCIATED WITH THE HEMATOMA. THE PATIENT REPORTS NO REC

  Patient problems: Bone Fracture(s); Fall; Hematoma; No Code Available; Swelling

  MAUDE report 10410827 ↗
• InjuryMar 16, 2020Naturally Worn; Naturally Worn

  LITIGATION ALLEGES PAIN AND INJURY. DOI: (B)(6) 2007; DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Edema; Injury; No Code Available; Osteolysis; Pain

  MAUDE report 9834967 ↗
• InjuryFeb 19, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT FAILURE. IT WAS NOTED THAT HER SUBTROCH OSTEOTOMY FAILED AND FEMORAL COMPONENT SUBSIDED. THERE WAS NOTABLE PAIN AND LEG LENGTH INEQUALITY. REVISION NOTES REPORTED SIGNIFICANT AMOUNT OF BONE LOSS IN THE GREATER TROCHANTER INCONTINUITY, A NON-DEPUY PLATE WAS NOTED TO HAVE FAILED, AND THE STEM WAS GROSSLY LOOSE. DOI: (B)(6) 2006; DOR: (B)(6) 2006; LEFT HIP.

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

  MAUDE report 9729277 ↗
• InjuryOct 21, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR, LOOSENING OF CUP, AND LOOSENING OF STEM. LINER AND CUP ARE NON DEPUY PRODUCTS. DOI: (B)(6) 2010 (HEAD); DOR: (B)(6) 2013 (RIGHT HIP); DOI: (B)(6) 2006 (STEM). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

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

  MAUDE report 9215693 ↗
• InjuryJul 19, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED VIA CD SHIPMENT LAST 04 APR 2019. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A PAINFUL AND LOOSE FEMORAL COMPONENT. THERE WAS A LOT OF SCAR TISSUE WHICH MADE REMOVAL OF THE STEM DIFFICULT. THE STEM WAS FOUND OUT TO BE ONLY FIXED ON THE PROXIMAL END. THE FEMUR CRACKED AND WAS BROKEN RIGHT WHEN THE SURGEON WAS ATTEMPTING TO DETERMINE THE FINAL LENGTH ON THE FEMORAL CUP AFTER ADDING THE NON-DEPUY REVISION STEM. THE FRACTURE WAS NOTED TO BE SHORT. CABLES WERE PLACED AROUND THE FEMUR. DOI: (B)(6) 2010 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Scar Tissue

  MAUDE report 8808833 ↗
• InjuryJun 21, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECORD REVEIVED. PPF ALLEGES INFECTION AND LOOSENING OF THE STEM. DOI: (B)(6) 2006 - DOR: (B)(6) 2007, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8723935 ↗
• InjuryMay 16, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED IN 2005 VIA THA. DURING THE SURGERY, A FRACTURE OF THE GREATER TROCHANTER OCCURRED AND THE SURGEON FIXED THE BONE BY WINDING A WIRE (REPORTED IN (B)(4)). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, BY REPLACING THE HEAD (P/N: 152190057), THE SLEEVE (P/N: 521463) AND THE S-ROM (P/N: 900529210) WITH MODULUS STEM MADE BY(B)(4). BONE GROWTH TO THE IMPLANT WAS NOT ACHIEVED. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8616634 ↗
• InjuryApr 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM. (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8504032 ↗
• InjuryMar 1, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT. PATIENT ALSO TESTED FOR METAL IONS WELL ABOVE AN ACCEPTABLE RANGE. DOI: (B)(6) 2011 : DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 8382326 ↗
• InjuryJan 28, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN. UPDATE REC'D 11/7/2014 - LITIGATION PAPERS RECEIVED. 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 1/23/2015 - THE REVISION OPERATIVE NOTE INDICATED PAIN AND PSEUDOTUMOR. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. UPDATE 11/25/2015- PFS AND MEDICAL RECORDS RECEIVED. THE MEDICAL RECORDS REPORTED PSEUDOTUMOR, SUBLUXATION, AND OSTEOLYSIS AT TIP OF GREATER TROCHANTER. SERUM COBALT LAB LEVEL OF 70 (REF 0.9) DATED (B)(6) 2010 WITHIN MEDICAL RECORDS. UPDATE AD 4 MAY 2018: THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, DISLOCATION WITH CLOSED REDUCTION, LOOSENING OF THE STEM, METAL WEAR, AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, NO OPERATIVE NOTES PROVIDED. ADDED S-ROM SLEEVE DUE TO LOOSENING OF STEM.

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

  MAUDE report 8281248 ↗
• InjuryJan 15, 2019Loss of Osseointegration; Loss of Osseointegration

  ALTHOUGH THERE ARE NO PATIENT SPECIFIC ALLEGATIONS, GENERAL LITIGATION ALLEGES METAL ON METAL, THEREFORE WE ARE REPORTING THE LINER AND HEAD. UPDATE 04 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. ADDED STEM DUE TO ALLEGATION.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8247505 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AFTER FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8047840 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION. DOI: (B)(6) 2015 - DOR: NOT REPORTED (LEFT HIP). (B)(4) FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 7620212 ↗
• InjuryJun 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION FOR PAIN.

  Patient problems: Pain

  MAUDE report 7582045 ↗
• InjuryApr 3, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE PATIENT HAD AN SROM THAT SUBSIDED. THE SURGEON REVISED HER STEM TO A RECLAIM AND SWAPPED OUT THE POLY LINER. DOI: (B)(6) 2011; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7393843 ↗