S-ROM ZTT 55-0502Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295175186), received between Dec 19, 2017 and Jan 15, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (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 15, 2025Migration; Migration

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT PERI-STEM FRACTURE OCCURRED AFTER A PRIMARY THA SURGERY. THIS PC REPORTS THAT DISLOCATION OCCURRED. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A PRIMARY THA FOR THE LEFT FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, PERI-STEM FRACTURE OCCURRED. WIRING WAS PERFORMED WITH OTHER COMPANY¿S GRIP AND CABLE IN (B)(6) 2024. ON (B)(6) 2025, THE SALES REP WAS INFORMED THAT DISLOCATION OCCURRED DUE TO STEM SINKING. ON JANUARY 7, 2025, THE SALES REP CONFIRMED THE DISLOCATION. SINCE THE PATIENT HAS A DISABILITY AND UNABLE TO COMMUNICATE, THE EVENT DATE IS UNKNOWN. THE SURGEON CANNOT GET ANY INFORMATION FROM THE PATIENT, AND EXACT TIME OF OCCURRENCE COULD NOT BE TOLD.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 21159089 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT DISLOCATION OCCURRED. THIS PC REPORTS THAT PERI-STEM FRACTURE OCCURRED AFTER A PRIMARY THA SURGERY. IT WAS REPORTED THAT ON (B)(6), 2012, THE PATIENT UNDERWENT A PRIMARY THA FOR THE LEFT FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, PERI-STEM FRACTURE OCCURRED. WIRING WAS PERFORMED WITH OTHER COMPANY¿S GRIP AND CABLE IN (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 21159024 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA THA. IMPLANTS WERE IMPLANTED IN MOM STATE. AFTER THE SURGERY, THE CUP LOOSENED DUE TO ARMD, AND THE REVISION SURGERY WAS PERFORMED OR WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20371534 ↗
• InjuryMay 10, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR THE RIGHT KNEE JOINT WITH THE IMPLANTS IN QUESTION. AFTER SURGERY, ON (B)(6) 2024, THE PATIENT FELL DOWN IN THE HOSPITAL. AS A RESULT, THE ENTIRE SLEEVE POST-TWISTED ON THE STEM AND SETTLED FURTHER. AFTER THAT, THE PATIENT ALSO HAD A DISLOCATION. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. A SLIGHT CERVICAL FRACTURE WAS CONFIRMED BUT WAS HANDLED BY INCREASING THE SIZE OF THE IMPLANT BY ONE SIZE AND WRAPPING IT WITH ETHIBOND PRIOR TO INSERTION OF THE IMPLANT. X-RAYS SHOWED NO PROBLEMS, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 19286762 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005 PATIENT DEVELOPED A DEEP VEIN THROMBOSIS POSTOPERATIVELY. DOI: (B)(6) 2005; DOE: (B)(6) 2005; RIGHT HIP. THIS (B)(4) IS A LINK OF (B)(4).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17070113 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS ALLEGES INJURY, WALKING DIFFICULTY, MENTAL AND PHYSICAL ANGUISH, SEVERAL EMOTIONAL DISTRESS AND DEPRESSION RELATING TO TRAUMA OF THE INJURIES. DOI: (B)(6) 2005, DOR: (B)(6) 2018, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Distress; No Code Available; Pain

  MAUDE report 8089562 ↗
• InjuryOct 18, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IMPLANTS WERE LOOSENED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7978666 ↗
• InjuryDec 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS INVERSION OF THE SLEEVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128587 ↗