S-ROM 1365-42-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295033752), received between Jan 3, 2014 and May 5, 2025 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION OF HEAD, LINER, AND STEM WAS DONE FOR STABILITY ISSUES (RELATED TO POLYETHYLENE WEAR). NEEDED TO CHANGE THE STEM VERSION TO MAKE PATIENT MORE STABLE AND TO STOP IMPINGEMENT. IT WAS MENTIONED THAT THE CUP COULD HAVE BEEN MALPOSITIONED. PROCEDURE WAS NOT EXTENDED DUE TO THIS EVENT. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21962450 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. SURGEON WASHOUT THE HIP AND EXPLANTED THE METAL LINER AND SROM HEAD. IMPLANTED A NEW ALTRX 56MM NEUTRAL LINER AND AN 36+3 SROM HEAD. NO DELAY IN SURGERY, NO INJURY TO PATIENT, PATIENT'S LEFT HIP. ORIGINAL DOS IS UNKNOWN - SURGEON COMMENTED IT WAS 17 YRS AGO. PATIENT STATUS/ OUTCOME / CONSEQUENCES ? YES. PATIENT CONSEQUENCE DESCRIPTION? WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. OTHER INFORMATION ? LEFT HIP. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF? PATIENT. DEVICE IN POSSESSION OF? HOSPITAL. (B)(4). DEVICE PROPERTY OF? PATIENT. DEVICE IN POSSESSION OF? HOSPITAL. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST? TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 16984892 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. PATIENT WAS REVISED DUE TO METALLOSIS. AS THE SURGEON DISSECTED SHARPLY DOWN TO THE FASCIA, MADE A STANDARD POSTEROLATERAL APPROACH IN THE HIP IN WHICH A BIT OF BRACKISH FLUID IS ENCOUNTERED. THERE WAS AN EXTENSIVE SYNOVITIS IN THE POSTEROLATERAL ASPECT OF THE HIP. AS THE HEAD BALL WAS DISLOCATED, A LITTLE BIT OF TRUNNIONOSIS WAS CLEANED OFF. CUP APPEARED TO BE OSSEOINTEGRATED.

  Patient problems: Foreign Body Reaction; Inflammation; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 16885246 ↗
• InjuryOct 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 15571525 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HIP AND LEG PAIN. STEM AND HEAD REMOVED AND REVISED WITH COMPETITORS COMPONENT. COMPETITOR CUP WAS NOT REVISED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11378143 ↗
• InjuryDec 22, 2020Naturally Worn; Naturally Worn

  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 ACECTABULAR COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. DOI: (B)(6) 2008 - DOR: (B)(6) 2020, (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 11055125 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP REPLACEMENT, ASEPTIC LOOSENING OF LEFT TOTAL HIP REPLACEMENT, AND FAILED METAL-ON-METAL TOTAL HIP ARTHROPLASTY. PATIENT WAS WITH A PAINFUL LEFT TOTAL HIP, WAS FOUND TO HAVE ASEPTIC LOOSENING OF HER LEFT FEMORAL STEM, AND WAS ALSO FOUND TO HAVE A METAL-ON-METAL TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES STATED THAT THE SHORT EXTERNAL ROTATORS WERE IDENTIFIED AND TAGGED FOR LATER REPAIR. THE FEMORAL STEM WAS GROSSLY LOOSE AND WAS ABLE TO MOVE IT BY HAND. THE S-ROM ZTT PROXIMAL SLEEVE AND STEM WERE WELL CONNECTED. THE HOOP EXTRACTOR WAS USED AND FOLLOWING REMOVAL OF LATERAL BONE WITH A HIGH-SPEED BUR, THE STEM WAS REMOVED WITHOUT ANY BONE LOSS. IT WAS GROSSLY LOOSE. REVERSE CURETTES WERE USED TO CLEAN THE PSEUDOMEMBRANE OUT THE FEMORAL CANAL. SCAR AND PSEUDOCAPSULE WAS DEBULKED. THE LEG LENGTHS WITH DISARTICULATION WERE RECREATED. THE PATIENT WAS SHORT PRIOR TO SURGERY FROM THE LOOSE SUBSIDED STEM. DOI: (B)(6) 2011 - DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Adhesion(s); No Code Available; Pain; Tissue Damage

  MAUDE report 10058895 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT ALLEGED PAIN. NO REVISION REPORTED. DOI: (B)(6) 2009. DOR: NONE REPORTED; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10014110 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, PAIN, ELEVATED METAL ION LEVELS AND OSTEOLYSIS. INTRAOPERATIVELY, TAN APPEARING SYNOVIAL FLUID CONSISTENT WITH METALLOSIS WAS OBTAINED. DISCHARGE SUMMARY NOTES HISTORY OF SWELLING AND MARKED LOSS OF FUNCTION. DOI: (B)(6) 2009; DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9794635 ↗
• InjuryFeb 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A DISLOCATING HIP. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9688535 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STIFFNESS, AND FULLNESS IN THE LEFT HIP REGION AS WELL AS A SMALL PSEUDOTUMOR. THE 40MM METAL ON METAL LINER AND 40MM HEAD ALONG WITH THE STEM WERE REMOVED AND REPLACED WITH 36/60 NEUTRAL LINER AND A NEW STEM AND 36MM DELTA 11/13 SROM HEAD WAS IMPLANTED. THE PATIENT REQUESTED ALL REMOVED IMPLANTS TO BE RETURNED TO HIM. DOI: (B)(6) 2008; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Edema; Foreign Body Reaction; Host-Tissue Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; Muscular Rigidity; Nausea; No Code Available; Pain

  MAUDE report 9246471 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN SROM MOM CONSTRUCT. PATIENT WAS REVISED DUE TO AN INFECTION. HEAD AND LINER WERE EXCHANGED FOR A POLY/METAL HEAD. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8745398 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. PINNACLE CLAIM HAS NO ALLEGATION PROVIDED. AFTER REVIEW OF MEDICAL RECORDS THERE WAS NO REVISION REPORTED. SHALL THERE BE NEW INFORMATION THIS COMPLAINT WILL BE UPDATED. DOI: (B)(6) 2008; DOR: UNKNOWN; LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705353 ↗
• MalfunctionJun 14, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS BILATERAL. PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Tissue Damage

  MAUDE report 8700140 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METAL TOXICITY AND PROGRESSIVE PAIN. X-RAYS WERE TAKEN PRIOR TO THE REVISION REVEALING WHAT LOOKED LIKE A LARGE BUBBLE OF OSTEOLYSIS OVER THE LATERAL SHOULDER OF THE IMPLANT AS WELL AS SOME FLATTENING OF THE CALCAR. OPERATIVE FINDINGS INCLUDE A LARGE POCKET OF BURSAL FLUID CONTAINING ABOUT 10 CC OF CLEAR, STRAW COLORED FLUID. THERE WAS A SIGNIFICANT AMOUNT OF SANDY-TYPE MATERIAL OVER THE AREAS CORRELATING WITH THE OSTEOLYTIC AREA ON THE X-RAY. FINALLY, THERE WERE SOME SCAR TISSUE AND A SMALL AMOUNT OF GRANULATION TISSUE BETWEEN THE CUP AND LINER. DOI: (B)(6) 2009 - DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: No Code Available; Osteolysis; Pain; Scar Tissue; Test Result

  MAUDE report 8674580 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL THR 2010 - PAIN GRADUALLY GETTING WORSE OVER THE YEARS - INVESTIGATED FOR HERNIAS/BACK PAIN - HIP BEING DIAGNOSED AS REASON FOR PAIN - METALLOSIS FROM MOM BEING DISCOVERED - REVISION THR COMPLETED AND MOM LINER/HEAD REMOVED AS WELL AS CUP AS LINER WOULD NOT COME OUT. REVISION PROSTHESIS INSERTED.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8487300 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION. DOI: (B)(6) 2011, DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8428758 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S METAL ON METAL CONSTRUCT WAS REVISED DUE TO PAIN ON LEFT HIP. A HEAD AND LINER EXCHANGED WAS PERFORMED WHERE A POLYETHYLENE LINER AND DELTA CERAMIC HEAD WERE IMPLANTED.

  Patient problems: Distress; Injury; No Code Available; Pain; Scar Tissue; Weakness

  MAUDE report 8292528 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR, ELEVATED METAL IONS, LOOSENING OF THE CUP AND STEM. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED THAT THE GLUTEUS MEDIUS ANTERIOR PORTION WAS AVULSED FROM THE BONE AND THERE WAS A MINIMAL AMOUNT OF BONE LOSS WHEN THE SOCKET WAS REMOVED. ON (B)(6) 2011, IT WAS STATED THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN IN THE GROIN AND THIGH. DOI: (B)(6) 2009; DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Injury; Pain; Test Result

  MAUDE report 8211814 ↗
• InjuryNov 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8115906 ↗
• InjuryJan 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT CHIEF COMPLAINT IS PAIN. THE SURGEON WENT IN AND REMOVED A METAL INSERT AND REPLACED IT WITH POLY INSERT. AT THIS TIME HE ALSO CHANGED THE HEAD TO ANOTHER METAL HEAD. THE STEM AND CUP WERE WELL FIXED AND RETAINED. ONE OTHER FACT IS THE FROZEN SECTION CAME BACK ACUTE INFLAMMATION. DOI: (B)(6) 2011; DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: Inflammation; Pain

  MAUDE report 7214967 ↗
• InjuryNov 13, 2017Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES METALLOSIS.

  Patient problems: Host-Tissue Reaction; Osteolysis

  MAUDE report 7024542 ↗
• InjuryAug 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6778480 ↗
• InjuryJan 3, 2014Insufficient Device Problem Information

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND EXTREME WEAKNESS IN THEIR HIP AND QUADRICEP.

  Patient problems: No Code Available; Pain

  MAUDE report 3550447 ↗