S-ROM ZTT 55-0535Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295175353), received between Oct 22, 2018 and Feb 1, 2024 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Migration” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, POPPING/SNAPPING, DIFFICULTY AMBULATING, AND ELEVATED METAL ION LEVELS. UPDATE: 7/3/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED ON THE LEFT SIDE BECAUSE OF METALLOSIS, VERTICAL CUP, AND SLIGHT CORROSION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 30 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METALLOSIS AND METAL WEAR. ADDED LAW FIRM, LAWYER, EXPIRY DATE OF THE HEAD, PATIENT HARM AND PEC. DOI: ON (B)(6) 2004 - DOR: NONE REPORTED (RIGHT HIP) PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 18623318 ↗
• DeathNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEATH, SECONDARY TO POSSIBLE GASTROINTESTINAL BLEED EVENT SERIOUS AND IS CONSIDERED SEVERE/FATAL. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION (NON-STUDY HIP): (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020 (DAY UNKNOWN) (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10838471 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SOFT TISSUE INFECTION WITH POSSIBLE DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT HIP). TREATMENT: NONE (AWAITING SURGICAL I&D WITH POSSIBLE REVISION).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10559980 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON (B)(6) 2009. PATIENT EXPERIENCED PAIN, INHIBITION OF THE ABILITY TO WALK, UNNECESSARY AND ADDITIONAL SURGERY, AND OTHER INJURIES PRESENTLY UNDIAGNOSED. PATIENT HAS BEEN AND/OR WILL BE FORCED TO UNDERGO A REVISION SURGERY. DOI: (B)(6) 2009 - DOR: N/I. PATIENT IS A RESIDENT OF (B)(6). UPDATE (B)(6) 2012 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED (PART/LOT) INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE (B)(6) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED WITH MEDICAL DOCUMENTS, WHICH IDENTIFIED DOB, DOI, DOR, SIDE INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOI: (B)(6) 2009 - DOR: (B)(6) 2012 (LEFT HIP). UPDATE AD (B)(6) 2019. (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PFS AND MED

  Patient problems: Discomfort; Edema; Fever; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Hypoesthesia; Inflammation; Limited Mobility Of The Implanted Joint; Necrosis; Osteolysis; Pain; Seroma; Test Result; Tissue Damage; Unspecified Infection; Wound Dehiscence

  MAUDE report 9928086 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION. DOI: (B)(6) 2011 (HEAD AND LINER) - DOR: (B)(6) 2012 (LEFT HIP); DOI: (B)(6) 2008 (CUP, SCREWS, STEM, AND SLEEVE). THIS PC IS FOR THE SECOND REVISION OF THE LEFT HIP. PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9163210 ↗
• InjurySep 25, 2019Migration; Migration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION, SLEEVE SUBSIDED LEADING TO SHORTENING OF THE LIMB, LED TO SLACKENING OF THE SOFT TISSUES. CLINICAL VISIT REPORTED PAIN, FALL, WOUND, SWELLING, DISCOMFORT AND MULTIPLE DISLOCATION. OPERATIVE FINDING REPORTED SUBLUXATED HIP AND ANTERIOR SCAR. DOI: (B)(6) 2006. DOR: (B)(6) 2014; RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Pain; Scar Tissue; Swelling

  MAUDE report 9120456 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, INFLAMMATION, DISCOMFORT, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 30 OCT 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEET RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION. ADDED DOR, LAW FIRM, SURGEON, HOSPITAL, EXPIRATION DATE, PATIENT HARM AND IP'S. DOI: (B)(6) 2008- DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 9071774 ↗
• InjuryApr 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT WAS REVISED TO ADDRESS INFECTED HIP. SURGEON EXPLANTED COMPONENTS REVISING WITH PROSTALAC SPACER. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8518178 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS. DOI: (B)(6) 2005 - DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Unspecified Infection

  MAUDE report 7991638 ↗