S-ROM ZTT 55-0533Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295175339), received between Jul 31, 2017 and Apr 6, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24790116 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE FULLY REMOVED DUE TO INFECTION. SURGEON PUT IN AN ANTIBIOTIC SPACER TO ALLOW THE INFECTION TO HEAL AND THE SITE WAS CLEANED THOROUGHLY BEFORE PUTTING IN THE ANTIBIOTIC SPACER. DOI: (B)(6) 2020 DOR: JAN 5, 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18493395 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL NOTIFICATION UPDATE INDICATES A REVISION WAS COMPLETED ON (B)(6) 2024 TO ADDRESS INFECTION. THE STEM, HEAD, LINER, AND CUP WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 16817078 ↗
• InjuryFeb 6, 2020Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND FEMORAL COMPONENT LOOSENING. REVISION NOTES REPORTED GROSS LOOSENING OF FEMORAL COMPONENT AND SMALL AMOUNT OF CORROSION AT THE TAPER. THERE WAS NO NOTED METALLOSIS. DOI: (B)(6), 2010: DOR: (B)(6), 2013; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9677835 ↗
• 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 RIGHT HIP. PLEASE SEE (B)(4) RIGHT HIP 1ST REVISION.

  Patient problems: Hypoesthesia; No Code Available

  MAUDE report 9617626 ↗
• InjurySep 23, 2019Adverse 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 INFECTION OF THE RIGHT HIP. THERE WAS AN OPEN WOUND, SWELLING, PAIN AND PUS. OPERATIVE NOTE REPORTED PUS ENCOUNTERED, CUP WAS LOOSED, BONE STOCK EXTREMELY DEFICIENT AND PATIENT HAD A MULTIPLE ALLERGIES. SURGICAL PATHOLOGY REPORTED ACUTE INFLAMMATION AND NECROSIS CONSISTENT WITH ACUTE OSTEOMYELITIS OF THE IMPLANTS PORTIONS OF BONE ARE IRREGULARLY SHAPED AND MARKEDLY DISRUPTED WITH ATTACHED TAN-PINK TO RED BROWN SOFT TISSUES AND BLOOD CLOT. DOI: (B)(6) 2008; DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Inflammation; Injury; Necrosis; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 9107734 ↗
• InjuryJul 1, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT ALLEGES HE SUFFERS FROM PAIN, AS WELL AS HIS DOCTORS "CONCLUDING THAT HIS HIP IS MOVING IN PLACES IT'S NOT SUPPOSED TO MOVE." LEGAL CLAIM ALLEGES LOOSENING, BUT DOESN¿T INDICATE WHAT PRODUCTS ARE LOOSE. AFTER REVIEWING, THE MEDICAL RECORDS THE SURGEON INDICATED THE PATIENT'S STEM AND SLEEVE NEED BE REVISED. HE ALSO STATES THE PATIENT HAS HIGH METAL IONS. THE PATIENT HAS NOT BEEN REVISED YET. AFTER READING THE PRIMARY OPERATIVE NOTE, IT INDICATED AN ANTERIOR SPLIT OCCURRED WHILE INSERTED THE TRIAL SLEEVE. THE TRIAL HEAD WAS THEN PLACED AND ANOTHER FRACTURE OCCURRED ANTERIOR AND ANTEROMEDIALLY OCCURRED THROUGH THE CALCHAR AREA. THE UNKNOWN DEPUY HIP IS BEING CHANGED TO AN UNKNOWN TRIAL SLEEVE. A UNKNOWN STEM AND SLEEVE ARE BEING ADDED FOR THE ALLEGED LOOSENING, BUT NOT REPORTED AS THERE HASN¿T BEEN A REVISION OR SERIOUS INJURY. THE UNKNOWN HEAD AND LINER ARE BEING ADDED FOR THE ALLEGED HIGH METAL IONS, BUT NOT REPORTED AS THERE HASN¿T BEEN A REVISION OR SERIOUS INJURY. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT. A DOI AND DOR WERE PROVIDED. WE ARE NOW REPORTING THE HEAD AND LINER DUE TO GENERAL METAL ON METAL ALLEGATION

  Patient problems: Discomfort; Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8747939 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION. DOI: (B)(6) 2011, DOR: NONE REPORTED (LEFT HIP). PLEASE SEE PC-000401279 LEFT HIP 1ST REVISION.

  Patient problems: Pulmonary Embolism

  MAUDE report 8428759 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE CALCAR FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8129535 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  REVISION WAS DONE DUE TO PAIN AND HIGH ION LEVELS.

  Patient problems: Fever; Inflammation; Pain

  MAUDE report 7984495 ↗
• InjuryJul 31, 2017Loose or Intermittent Connection; Loss of Osseointegration; Osseointegration Problem; Loose or Intermittent Connection; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN. UPDATE JUL 05, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES SWELLING, LIMPING, IMPROPER FOOT ALIGNMENT, TISSUE NECROSIS. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND FAILED METAL/METAL ARTICULATION. REVISION NOTE STATED THAT THE STEM WAS FOUND TO BE GROSSLY LOOSE, SIGNIFICANT OVERGROWTH OF HETEROTOPIC BONE AND OVERGROWTH OF THE TROCHANTER. ADDED STEM AND SLEEVE DUE TO THE REPORTED LOOSENING. PART AND LOT INFORMATION WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON: JUL 19, 2017.

  Patient problems: Inadequate Osseointegration; Joint Swelling; Necrosis; Pain

  MAUDE report 6754109 ↗