S-ROM ZTT 55-0504Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295175209), received between Nov 9, 2017 and May 2, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, DUE TO THE SUSPICION OF TRANIONOSIS. THE DETAILED INFORMATION WILL BE UPDATED AT A LATER DATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 16853792 ↗
• InjuryJan 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR RIGHT OA WITH S-ROM-A STEM IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED ON (B)(6) 2022, THAT THE STEM BROKE ON BODY PART AND SLIT ROOT PART. IT CAN SEE THE BROKEN PARTS IN THE ATTACHED PHOTO. A REVISION SURGERY IS PLANNED ON (B)(6) 2023. THE SURGEON WANTS TO KNOW THE OCCURRENCE SITUATION OF THE EVENT WHERE THE STEM IS BROKEN IN TWO PLACES (STEM BODY PART AND SLIT BASE PART) LIKE THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16137617 ↗
• InjuryDec 20, 2019Fracture; Use of Device Problem; Malposition of Device; Fracture; Use of Device Problem; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016 VIA THA. IT WAS REPORTED THAT IT WAS CONFIRMED THE STEM (P/N: 900525210) AND THE SLEEVE (P/N: 550504) FRACTURE BY X-RAY WHEN THE PATIENT VISITED TO THE HOSPITAL ON (B)(6) 2019, AND THE PATIENT¿S CONDITION WAS UNWALKABLE. THUS, THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED IN THE NEAR FUTURE (DATE OF SURGERY WAS NOT FIXED YET). POSSIBLE CAUSE: THE IMPLANTS IN QUESTION HAD BEEN PLACED IN A LITTLE BIT VARUS AT THE PRIMARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9505566 ↗
• InjuryDec 7, 2018Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 8142212 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENDING PRODUCT LIABILITY, PFS ALLEGES PAIN, NEUROPATHY ON THE RIGHT FOOT, MUSCLE SPASM, AND MUSCLE ATROPHY. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED PAINFUL RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED THAT A FAIR AMOUNT OF BLOODY FIBROUS DEBRIS WAS CULTURED AND DEBRIDED. THE STEM WAS FOUND TO BE LOOSE AND BROKEN. INTRAOPERATIVE RADIOGRAPH SHOWED THAT PERFORATION HAD OCCURRED AT THE LATERAL CORTEX, SO AN ETO WAS PERFORMED. A CRACK WAS THEN NOTED AT THE DISTAL PART OF THE FEMUR, AND TWO CABLES WERE PASSED DISTALLY, AND ALSO TWO PROXIMALLY, TO REPAIR THE ETO.

  Patient problems: Fibrosis; Muscle Spasm(s); Neuropathy; No Code Available; Pain; Tissue Damage

  MAUDE report 7966422 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED (DATE OF THE PRIMARY SURGERY AND THE REMOVAL SURGERY WERE UNKNOWN) DUE TO THE INFECTION. THE SURGEON IMPLANTED CEMENT SPACER INTO THE PATIENT¿S BONE. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7596069 ↗
• InjuryNov 9, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF FEMORAL PART AT UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 7012905 ↗