S-ROM ZTT 55-0530Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295175322), received between Jun 29, 2017 and Jul 27, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Osseointegration Problem

  Patient was revised due to loosening of the sleeve and stem at the bone to implant interface. No delay. No harm to patient. No additional information is available.DOI- (b)(6) 2019.DOR- (b)(6) 2026.Affected side: Left hip.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50017177 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN (B)(6) 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.

  Patient problems: Unspecified Infection

  MAUDE report 22084821 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CARDIOVASCULAR COMPLICATIONS (E.G. MI). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005; DATE OF EVENT: 14 MAR 2024 (LEFT HIP). TREATMENT: NONE.

  Patient problems: Myocardial Infarction

  MAUDE report 19019605 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE THE LEFT FEMUR. FEMORAL STEM, SLEEVE AND HEAD WERE REMOVED TO FIX FRACTURE. NEW STEM, SLEEVE AND HEAD WERE REPLACED. DOI: (B)(6) 2023. DOR: OCT 27, 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18074570 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS REPORTED THAT PATIENT POST 1ST REVISION PATIENT STILL COMPLAINTS OF PAIN, ACHES, LIMITATIONS WITH ACTIVITY, HIGH COBALT AND CHROMIUM LEVELS CONTINUED UNTIL DEATH. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT PATENT SUFFERED POST OPERATIVE ACUTE BLOOD LOSS ANEMIA. DOI: (B)(6) 2005 (STEM,SLEEVE), DOI: (B)(6) 2013 (CUP,SCREWS,APEX,LINER,HEAD), DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Pain

  MAUDE report 12333839 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM LETTER RECEIVED. PATIENT ALLEGES CONSTANT PAIN, WALKING DIFFICULTY AND ABSCESS WHICH RESULTED IN A REVISION OF THE RIGHT HIP. DOI: (B)(6) 2009 - DOR: (B)(6) 2020 (RIGHT HIP).

  Patient problems: Abscess; Foreign Body Reaction; Metal Related Pathology; No Code Available; Pain

  MAUDE report 10788289 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT THE SURGEON HAD DISCOVERED THAT THERE WAS A STRONG FORMATION BETWEEN A DEFECTIVE HIP JOINT AND IT'S GOING BAD. PATIENT HAS BEEN EXPERIENCING IT SINCE 2017. PATIENT'S HUSBAND STATED THEY ARE TRYING TO GET IT REMOVED AND REPLACED. DOI: (B)(6) 2005. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Heart Failure; No Code Available; Pain; Test Result

  MAUDE report 10049193 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. PAIN AND SWELLING WERE ALSO NOTED. REVISION NOTES REPORTED GROSS PURULENCE; NO METALLOSIS, SIGNIFICANT WEAR NOR METAL DEBRIS WERE FOUND. IT WAS STATED THAT THE PATIENT HAD A SUPERFICIAL INFECTION IN HIS ARM THAT SUBSEQUENTLY SPREAD TO HIS HIP. IT WAS ALSO NOTED THAT POST INITIAL HIP REPLACEMENT, THE PATIENT WAS ADMITTED DUE TO POST OP INFECTION DUE TO A SUPERFICIAL WOUND INFECTION THEN WAS TREATED WITH I&D AND 3 WEEKS OF IV ANTIBIOTICS. DOI: (B)(6) 2009; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9627662 ↗
• InjuryAug 12, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE STEM AND SLEEVE AT THE BONE TO IMPLANT INTERFACE IN THE LEFT HIP 23 YEARS FOLLOWING THR. SURGEON REMOVED LOCKING PINS, CUP, LINER, DOME SCREWS, SLEEVE, STEM AND HEAD. THE ZTT CUP REMAINED IMPLANTED. THE SURGEON PLACED A NEW POLY DIAL LINER LOCKING PINS. DOI: (B)(6) 1996. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8884515 ↗
• InjuryJan 29, 2019Adverse 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, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 14 JAN 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS.

  Patient problems: Discomfort; Inflammation; Pain; Unspecified Infection

  MAUDE report 8284912 ↗
• InjuryOct 31, 2018Loose or Intermittent Connection; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS MECHANICAL LOOSENING.

  Patient problems: Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8024534 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS THIGH PAIN. THE PATIENT WAS EXPERIENCING THIGH PAIN, POTENTIALLY DUE TO THE STEM BEING LOOSE AS THE IMPLANTS WERE EASILY REMOVED.

  Patient problems: Pain

  MAUDE report 6853030 ↗
• MalfunctionJun 29, 2017Break; Loss of Osseointegration; Break; Loss of Osseointegration

  IT WAS REPORTED THAT SIDES OF T HANDLE HOLDER BROKE.

  Patient problems: Bone Fracture(s); No Information; Pain

  MAUDE report 6677581 ↗
• InjuryJun 29, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  JUN 01, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED ON THE REVISION OPERATIVE NOTE THAT THERE WAS EVIDENCE OF A LONGITUDINAL FRACTURE IN THE BONE AS WELL AS LOOSENING OF THE FEMORAL COMPONENT POSTEROLATERALLY WITH SOME MISSING BONE IN THE GREATER TROCHANTER. PART AND LOT INFORMATION WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON: JUN 09, 2017. UPDATE 6/1/2017 AFTER FURTHER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS NOTED THAT THE S-ROM PROXIMAL SLEEVE WAS INDICATED LOOSE BY THE REVISING SURGEON, AND THE DISTAL STEM WAS WELL-FIXED. THEREFORE, THE PROXIMAL SLEEVE HAS BEEN ADDED TO THE COMPLAINT FOR IMPLANT LOOSENING, AND THE IMPLANT LOOSENING HARM IS REMOVED FROM THE STEM PRODUCT. THIS COMPLAINT WAS UPDATED ON: JUN 28, 2017.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 6677545 ↗