S-ROM ZTT 55-0536Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295175360), received between Jul 21, 2017 and Jul 15, 2022 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. LEFT HIP TREATMENT: REMOVAL OF ALL COMPONENTS WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Unspecified Infection

  MAUDE report 15033935 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION AND DRAINAGE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANTATION: (B)(6) 2013. DATE OF REVISION #1: (B)(6) 2013. DATE OF REVISION #2: (B)(6) 2015. DATE OF REVISION #3: (B)(6) 2021. DATE OF REVISION #4: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (LEFT HIP). TREATMENT: AWAITING REVISION.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 14699965 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14565162 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTION: 1. FOLLOW-UP FOR WHICH APEX HOLE ELIMINATOR(PRODUCT DETAILS). A. ''YOU HAVE PROVIDED US TWO DIFFERING APEX HOLE ELIMINATORS. AS IT IS NOT POSSIBLE FOR THE PATIENT TO HAVE HAD TWO OF THEM IMPLANTED, WHICH ONE WAS IN PLACE AT THE TIME OF THIS REVISION? ANSWER: THE ORIGINAL APEX HOLE ELIMATOR WAS PROBABLY DAMAGED OR STRIPPED SO A NEW ONE WAS REQUIRED ON (B)(6) 2013.

  Patient problems: Hematoma; Impaired Healing

  MAUDE report 12062905 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS WOUND BREAKDOWN WITH HEMATOMA AND DRAINAGE, RECURRENT INSTABILITY WITH DISLOCATION, AND COAGULOPATHY. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A REVISION 6 WEEKS PRIOR (CAPTURED IN (B)(4)) TO ADDRESS A FAILED CONSTRAINED LINER AND MEDICAL RECORDS INDICATED THE PATIENT WAS HAVING PAIN.. THE PATIENT DISLOCATED AFTER THAT SURGERY AND NEEDED A REDUCTION. DURING THIS CURRENT PROCEDURE THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE SURGEON REPORTED FINDING A COMPLETE FAILURE OF THE POSTERIOR SOFT TISSUE, AND REALLY NO LONGER ANY SOFT TISSUES PRESENT TO REPAIR. THERE WAS A SMALL AMOUNT OF HEMATOMA. HE WAS COAGULOPATHIC DURING THE CASE.

  Patient problems: Fluid Discharge; Hematoma; Joint Laxity; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11871938 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RIGHT HIP PROSTHETIC INFECTION, METALLOSIS, PSEUDOTUMOR. REVISION NOTE STATED THAT COPIOUS PURULENCE WAS NOTED IN ADDITION TO METALLOSIS DEBRIS. ALL COMPONENTS WERE REMOVED. THE ACETABULAR COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. DOI: (B)(6) 2008; DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 11055166 ↗
• InjuryApr 17, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT IS NOW ALSO EXPERIENCING PAIN AND DISCOMFORT ON HIS LEFT SIDE, WHICH WILL ALSO REQUIRE A REVISION SURGERY IN THE NEAR FUTURE. UPDATE REC'D 1/15/14 AND 2/7/2014- PFS AND MEDICAL RECORDS RECEIVED. OPERATIVE NOTES REVIEWED THE HEAD AND LINER ARE NOW BEING ADDED FOR THE LEFT AND RIGHT PRIMARY IMPLANTS. THE REVISION OPERATIVE NOTE FOR THE RIGHT IMPLANT NOTED FEMORAL LOOSING SO THE STEM AND SLEEVE ARE NOW BEING REPORTED. UPDATE AD 30 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE STEM. THE STEM AND SLEEVE HAS BEEN ADDED DUE TO A NEW ALLEGATION OF LOOSENING.

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 8522537 ↗
• InjuryMar 26, 2019Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGED PSEUDOTUMOR.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; Osteolysis; Pain; Swelling; Tissue Damage

  MAUDE report 8451114 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8264003 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. UPDATE 11/23/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO INFECTION, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT, SWELLING IN THE LEG, AND DIFFICULTY SLEEPING. UPDATE AD 11 MAY 2018: THE RECEIPT OF PPF AND MEDICAL RECORDS RECEIVED. PPF HAS NO NEW ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS GROSS INFECTION AND HYPERTROPHIC SCAR. REVISION NOTES REPORTED THAT THERE WAS A FULL BLOWN OUTWARD FLOW OF PUS AFTER EXCISION OF THE FASCIA AND REMOVING THE CALCAR COMPONENT MADE FRACTURES AND CRACKS AND QUARTER SIZE BONE LOSS IN THE DIRECT LATERAL PART OF THE FEMUR.

  Patient problems: Bone Fracture(s); Discomfort; Injury; Pain; Swelling; Unspecified Infection

  MAUDE report 8088697 ↗
• InjuryMay 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES PATIENT HAD SROM METAL ON METAL (B)(6) 2008. HE WAS REVISED BILATERALLY ON (B)(6) 2014 WITH A BIOLOX DELTA 36+0 HEAD AND A 54+41 ALTRX LINER. THE BIOLOX ON THE RIGHT HIP SHATTERED CAUSING THE TRUNION TO PENETRATE THE LINER WHICH IT DID PORTRUDE AND ARTICULATE ON THE INSIDE OF THE METAL SHELL. THE TRUNION WAS DEFORMED FORCING A WELL FIXED STEM TO BE REMOVED. THE FEMUR WAS SHATTERED IN THE PROCESS. IT WAS ALSO STATED THAT THE LINER WAS WORN DUE TO TRUNION. DOI: (B)(6) 2008 FOR STEM AND SLEEVE; DOI- (B)(6) 2014 HEAD AND LINER; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Bone Fracture(s); No Code Available; Not Applicable

  MAUDE report 7540815 ↗
• InjuryApr 17, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LATERAL SUBSIDENCE OF THE STEM. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7436082 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT REPORT STATED THAT PATIENT REPORTED SYMPTOMS OF EXTREME PAIN AND AMBULATION DIFFICULTIES. PATIENT HAS AN ALLERGY TO NICKEL AND VANADIUM.

  Patient problems: Pain

  MAUDE report 6732386 ↗