S-ROM ZTT 52-1423Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295170594), received between Sep 22, 2017 and Sep 16, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT ALL IMPLANTS WERE LOOSE AND THERE WERE NO INSTRUMENTS THAT BROKE DURING THE CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 12483217 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD AND STICKER SHEETS RECEIVED. DURING IMPLANTATION THE CALCAR WAS CRACKED WHILE INSERTING THE SLEEVE. DOI: (B)(6) 2006. DOE: (B)(6) 2006. (LEFT HIP).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8807322 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGE INFECTION REQUIRING IV ANTIBIOTICS. DOI: (B)(6) 2013 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8529175 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES THAT THE PATIENT SUFFERS FROM DISLOCATION, PAIN, PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2005 - DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: Discomfort; Pain

  MAUDE report 8230720 ↗
• InjuryJul 16, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM. IT WAS ALSO INDICATED IN STICKERS SHEETS THAT PINNACLE SECTOR II ACETABULAR CUP, PINNACLE CANCELLOUS BONE SCREW, S-ROM TOTAL HIP SYSTEM FEMORAL STEM STANDARD, AND S-ROM TOTAL HIP SYSTEM ZTT PROXIMAL SLEEVE WERE IMPLANTED ON (B)(6) 2006. DOI: (B)(6) 2006 - DOR: (B)(6) 2010 ;(RIGHT HIP).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7689496 ↗
• InjuryMar 21, 2018Loss of Osseointegration; Loss of Osseointegration

  CLINICAL ADVERSE EVENT RECEIVED FOR CELLULITIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT NOT RELATED TO DEVICE. EVENT IS RELATED TO PROCEDURE. DOI: (B)(6) 2014. DOE: (B)(6) 2014. (RIGHT KNEE). ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE COMPONENTS LISTED ON (B)(4) CORRECTLY REFLECT THE OPERATIVE NOTES. ON (B)(6) 2014, THE PATIENT EXPERIENCED A WITNESSED FALL AND LEFT THE FACILITY AGAINST MEDICAL ADVICE AND RETURNED TO THE FACILITY ON THE SAME DAY DUE TO A PERIPROSTHETIC FEMUR FRACTURE. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION OF A RIGHT TOTAL HIP ARTHROPLASTY DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO LOOSENING AND PERIPROSTHETIC FRACTURE. THE LOOSENING IS INDICATED TO BE THE FEMORAL COMPONENT. THE SURGEON NOTED THE PROXIMAL CALCAR FRACTURE AREA WAS REPAIRED WITH SEVERAL 16-GAUGE STAINLESS STEEL WIRES.

  Patient problems: Bone Fracture(s); Cellulitis; Inadequate Osseointegration

  MAUDE report 7356771 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT DURING A ZIMMER KNEE REVISION SURGEON ELECTED TO PLACE AN SROM SLEEVE INTO THE TIBIA AS A TIBIAL CONE INPLANT.

  Patient problems: No Code Available

  MAUDE report 6886881 ↗