S-ROM ZTT 55-0534Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295175346), received between Jun 22, 2017 and Jun 11, 2021 — classified as 1 death, 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION, AND REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENTS MAY ALSO HAVE ARMD. INTRAOPERATIVELY, THE SURGEON IDENTIFIED EXTENSIVE FEMORAL AND ACETABULAR BONE LOSS. A NEW IMPLANT WILL BE REPLACED AFTER CEMENT BEADS ARE PLACED AND CRP IS LOWERED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI:UN K; DOR: (B)(6) 2011 ((B)(4)); DOR: 6/1/2021; UNK HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11984717 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT SURGEON PERFORMED THE ORIGINAL SURGERY ON (B)(6) 2012. THE PATIENT ENDED UP DEVELOPING A HIP INFECTION AND NEEDING AN ANTIBIOTIC SPACER. THE SURGEON REMOVED THE SROM STEM AND PINNACLE ACETABULAR COMPONENTS. THE PATIENT WAS THEN PREPPED FOR A SIZE 1 HI OFFSET (SIZE 3 PROSTALAC MOLD). ONCE THE PROSTALAC STEM AND CUP WERE IMPLANTED, A FINAL TRIAL REDUCTION WAS PERFORMED. A SIZE 32MM +5 WAS DEEMED APPROPRIATE AND IMPLANTED. PATIENT LEG LENGTH AND STABILITY WAS CHECKED, FOUND TO BE SATISFACTORY, AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2012. DOR: (B)(6) 2021. (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11158146 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING ABOUT SOME DISTAL THIGH PAIN SO THE SURGEON REMOVED THE HEAD AND STEM AND REPLACED THEM WITH NEW COMPONENTS. DOI: (B)(6) 2018. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10528118 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BURSITIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT HIP). TREATMENT: NONE (AWAITING SURGICAL BURSECTOMY).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10298746 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP ARTHROPLASTY. THERE WERE NO OTHER EVENT OR FINDINGS DURING THE REVISION SURGERY. DOI: (B)(6) 2006, DOR: (B)(6) 2007, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9891792 ↗
• InjuryOct 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE 9/30/2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, A CORRECT DOR WAS PROVIDED. THE PATIENT WAS REVISED ON (B)(6) 2013 FOR INFECTION. ALL IMPLANTS WERE REMOVED AND SPACERS WERE PLACED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2013 WITH COMPETITOR PRODUCTS. THE (B)(6) 2013 REVISION OPERATIVE NOTE INDICATED LOOSENING, BUT DIDN'T INDICATE WHICH PRODUCTS WERE LOOSE. LAB RESULTS WITHIN THE PFS INDICATED THE METAL ION LEVELS WERE LESS THAN 7PPB. AT THIS TIME INFECTION ISN'T ALLEGED PER THE LITIGATION. ALL OTHER PRODUCTS ARE BEING ADDED TO THE COMPLAINT, BUT PUT IN AS MDR NOS. PART / LOT IS BEING UPDATED FOR THE HEAD / LINER. UPDATE AD 13 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP AND STEM. AFTER RE-REVIEW OF MEDICAL RECORDS ATTACHED IN ETQ, REVISION NOTES DID NOT MENTION ANY LOOSENING. DOI: (B)(6) 2007. DOR: (B)(6) 2013, (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain; Unspecified Infection

  MAUDE report 9185445 ↗
• DeathAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PINNACLE METAL LINER AND SROM METAL HEAD WERE REMOVED BECAUSE OF METALLOSIS. DOI: UNKNOWN; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Death; Foreign Body Reaction; Injury; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8879903 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PULMONARY EMBOLISM. LEFT HIP.

  Patient problems: Pulmonary Embolism

  MAUDE report 8539729 ↗
• InjuryApr 9, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE REC'D 1/25/2016: DER RECEIVED. PATIENT WAS REVISED PER PATIENT REQUEST. SLEEVE, STEM, LINER, AND FEMORAL HEAD WAS REVISED. UPDATE AD 12 NOV 2014: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Discomfort; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8495141 ↗
• InjuryOct 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8005937 ↗
• InjuryOct 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8005785 ↗
• InjuryOct 11, 2018Loose or Intermittent Connection; Inadequacy of Device Shape and/or Size; Loose or Intermittent Connection; Inadequacy of Device Shape and/or Size

  STEM AND SLEEVE LOOSE AND SUBSIDED. SURGEON FELT THEY WERE SLIGHTLY UNDERSIZED. INFECTION HAS BEEN PRESENT AT SOME STAGE.

  Patient problems: Unspecified Infection

  MAUDE report 7956900 ↗
• InjurySep 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES PAIN AND WEAKNESS. DOI: (B)(6) 2003- DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Not Applicable; Pain; Weakness

  MAUDE report 7869935 ↗
• InjuryJul 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  JUNE 13, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN AND SUFFERING ASSOCIATED WITH HIP REVISION WITH SURGICAL SCARRING AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT UNDERWENT SURGICAL IRRIGATION AND DEBRIDEMENT DUE TO METAL-ON-METAL COMPLICATION AND INFECTED RIGHT THA. OPERATIVE NOTES NOTED A SIGNIFICANT METALLOSIS TYPE DEBRIS AND SOME MILKY WHITE FLUID CONSISTENT WITH EITHER INFECTION OR METALLOSIS. THERE WAS ALSO NOTED TO BE SOME METALLOSIS AND NECROSIS OF THE ANTERIOR SOFT TISSUES AT THE INTERIOR AND INFERIOR BORDER OF THE ABDUCTORS. THE SIGNIFICANT PORTION OF THE TROCHANTER WAS LOADED IN FULL METAL DEBRIS. IT WAS ALSO REPORTED THAT DURING THE COMPLETING OF THE DEBRIDEMENT OF THE TROCHANTER, THEY DID NOTICE THAT PATIENT'S MEAN ARTERIAL BLOOD PRESSURE HAD SIGNIFICANTLY DECREASED. THE ANESTHESIA TEAM WAS HAVING DIFFICULTY KEEPING THIS IN APPROPRIATE RANGE WITH THE PRESSORS, SO THE MEDICAL TEAM DECIDED TO QUICKLY CLOSE THE WOUND TO ALLOW THE PATIENT RETURN TO A SUPINE POSITION AND LIKELY TRANSFER THE PATIENT BACK TO THE ICU. ON (B)(6) 2015, WHEN PATIENT WAS STABILIZED, HE UNDERWENT SURGICAL EXPLANT OF THE RIGHT

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 6707164 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE OF THE FEMUR AROUND THE STEM AFTER A FALL. THE FRACTURE WAS REDUCED AND SECURED USING CABLES AND WIRES.

  Patient problems: Bone Fracture(s)

  MAUDE report 6662593 ↗