S-ROM ZTT 55-0525Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295175308), received between Nov 4, 2017 and Jan 2, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  ON (B)(6) 2023, THE PATIENT UNDERWENT A TOTAL LEFT HIP REVISION ARTHROPLASTY. INTRAOPERATIVE FINDINGS INCLUDED THAT THE SROM SLEEVE AND STEM WERE GROSSLY LOOSE AT THE BONE-TO-IMPLANT INTERFACE. OSTEOTOMES AND AN OSCILLATING SAW WERE CREATED TO CLEAR AWAY EXTRA BONE TO RELEASE THE STEM AND SLEEVE. SUBSIDENCE WAS ALSO IDENTIFIED WHICH ALSO CAUSED A LOSS OF LEG LENGTH. THE PATIENT WAS CONVERTED TO A DUAL MOBILITY SYSTEM BUT NO ALLEGATIONS WERE NOTED AGAINST THE ORIGINAL LINER/HEAD. USFDA DETERMINATION: THE PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AND SLEEVE IN THE FEMORAL BONE. THE STEM/SLEEVE ARE BEING REPORTED AS THEY ARE WHAT WAS NOTED TO BE GROSSLY LOOSE. THE REVISION OF THE LOOSE STEM/SLEEVE LED TO SUBSIDENCE, WHICH THEN LED TO THE LEG LENGTH DISCREPANCY, WHICH CAUSED THE SURGEON TO CONVERT TO A DUAL MOBILITY SYSTEM THE EVENT DESCRIPTION NOTED "NO ALLEGATIONS WERE NOTED AGAINST THE ORIGINAL LINER/HEAD.". THERE WAS ALSO NOT ALLEGATIONS OF DEFICIENCY NOTED FOR THE CUP AND SCREWS. DOI: (B)(6) 2016. DOR: (B)(6) 2023. LEFT HIP. PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Inadequate Osseointegration; Physical Asymmetry

  MAUDE report 18426390 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO ADDITIONAL DETAILS. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 15445487 ↗
• InjuryApr 1, 2020Loss of Osseointegration; Loss of Osseointegration

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY. PATIENT HAD LEFT HIP PAIN. REVISION NOTES STATED. SCHLEROTIC BONE IN THE TROCHANTERIC BED AND THE PROXIMAL SLEEVE WAS REMOVED AS IT WAS NOT INGROWN AND WAS GROSSLY LOOSE. DOI: (B)(6) 2005; DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9912442 ↗
• InjuryMar 13, 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, DURING THE REVISION SURGERY, WHEN THE SURGEON PLACED THE ZTT, THE PAPER THIN BONE STARTED TO HAVE A SMALL DIASTASIS. THREE COMPETITOR CABLES WERE PLACED TO KEEP IT STABLE AND SO THAT THE FEMUR WOULD NOT SHATTER. DOE: (B)(6) 2011.

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

  MAUDE report 9828867 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT PATIENT HAD A FALL ON (B)(6) 2018 AND HAD DISLOCATION. CLOSE REDUCTION WAS NOT SUCCESSFUL. THE PATIENT WAS THEN REVISED WITH DIAGNOSIS OF DISLOCATION OF THE LEFT HIP REPLACEMENT, HISTORY OF ACUTE PERIPROSTHETIC INFECTION OF THE LEFT HIP REPLACEMENT AND FRACTURE OF THE GREATER TROCHANTERIC FRAGMENT, LEFT HIP. OPERATIVE NOTES INDICATED THAT AFTER DISSECTING THROUGH THE SUBCUTANEOUS LAYER, WE NOTICED IMMEDIATELY A LARGE SEROMA-HEMATOMA. THERE WAS PARTIAL DEHISCENCE OF THE FASCIAL CLOSURE. MIGRATION OF THE TROCHANTERIC FRAGMENT THAT WAS PREVIOUSLY REPAIRED USING NON-ABSORBABLE SUTURES. LINER IS A COMPETITOR. DOI: (B)(6) 2005 (STEM); DOI: (B)(6) 2018 (HEAD); DOR: (B)(6) 2018 (HEAD); LEFT HIP. 1ST REVISION WAS CAPTURED ON (B)(4).

  Patient problems: Bone Fracture(s); No Code Available; Seroma

  MAUDE report 9670784 ↗
• MalfunctionOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REVIEW OF THE MEDICAL RECORDS FROM THE (B)(6) 2010 REVISION, THE SURGEON STATES "THE FEMORAL SLEEVE WAS SECURE AND THE STEM WAS SECURE WITHIN THE SLEEVE BUT UPON SIMPLE REMOVAL ATTEMPTS ON THE FEMUR, IT WAS NOTED THAT THE FEMORAL STEM WAS FAIRLY LOOSE AND EASILY REMOVED" THEREFORE, THE SLEEVE IS NOT REPORTABLE AT THIS TIME AS NO PATIENT HARM OCCURRED FROM THIS PRODUCT.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9144867 ↗
• InjuryApr 24, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES BONE FRACTURE AND LOOSENING OF STEM. UNKNOWN HIP IMPLANT IS ADDED TO CAPTURE THE ALLEGATION OF FRACTURE AS IT IS UNKNOWN WHERE THE FRACTURE WAS.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8544678 ↗
• InjuryNov 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRICTION AND WEAR CAUSING TOXIC METAL IONS AND PARTICLES, PAIN, POPPING SENSATION, METALLOSIS, AND TROCHANTERIC OSTEOLYSIS. THERE ARE NO MEDICAL RECORDS PROVIDED. PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PFS ALSO ALLEGES DISCOMFORT, LIMITED MOBILITY, LIMPING, AND INABILITY TO EFFECTIVELY PERFORM ACTIVITIES OF DAILY LIVING. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, PAIN, TROCHANCENTRIC OSTEOLYSIS, AND PATHOLOGIC FRACTURE OF THE GREATER TROCHANTER. REVISION NOTES REPORTED DARKENED BURSA AND SCARRING. MRI REPORT SUGGESTS SOFT TISSUE SWELLING, SMALL HEMATOMA, AND FATTY ATROPHY.

  Patient problems: Bone Fracture(s); Claudication; Discomfort; Foreign Body Reaction; Hematoma; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Scarring; Swelling; Tissue Damage

  MAUDE report 7002164 ↗