S-ROM 87-5953Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295218838), received between Jul 26, 2017 and Apr 9, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. PATIENT WAS DONE 17 YEARS AGO. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24828319 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED APPROXIMATELY 15 YEARS AGO AND DID WELL UNTIL RECENTLY THE PATIENT BEGAN TO FEEL UNSTABLE. THE ORIGINAL DOS, SURGEON, AND PLACE OF SURGERY IS UNKNOWN. THE PATIENT CAME IN AND SEEN THE SURGEON WHERE THE SURGEON DETERMINED THAT POLYETHYLENE WEAR WAS THE CAUSE OF THE INSTABILITY SENSATION THE PATIENT WAS FEELING. A REVISION SURGERY WAS DONE WHERE THE SURGEON REPLACED THE HIP BALL AND LINER. THE LOT NUMBER INFORMATION WAS UNABLE TO RETRIEVED BECAUSE OF THE WEAR ON THE IMPLANTS. THE SROM STEM AND PINNACLE CUP WERE LEFT IN VITRO AND WERE WELL FIXED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24279853 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT, MODULAR COMPONENTS EXCHANGED WHILE IN CAPSULE. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22650348 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF HIP. HEAD AND LINER EXCHANGED WHILE IN JOINT. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22542646 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUP, LINER AND HEAD WERE REMOVED FOR INSTABILITY. CUP AND LINER UNKNOWN MANUFACTURER. DOI: (B)(6) 2001, DOR: (B)(6) 2023, AFFECTED SIDE : LEFT HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 17875283 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 14381401 ↗
• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RECURRENT DISLOCATION. NO ADDUCTOR ATTACHMENT. THERE WAS NO SUGGESTION THAT THE PRODUCT DID NOT WORK AS INTENDED. THERE WERE NO PRIOR REVISION SURGERIES. THE LOT NUMBER IS FROM THE POLY ITSELF, POSSIBLY THE NUMBERS WERE WORN. PATENT HAD THREE CLOSED REDUCTIONS IN THE WEEKS LEADING UP TO THE REVISION. PATIENT THOUGHT THE INDEX PROCEDURE WAS 18-20 YEARS AGO. DOI: (B)(6) 2003; DOR: (B)(6) 2021: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11553883 ↗
• InjurySep 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED AS THAT PATIENT DISLOCATED. SURGEON REMOVED COMPETITOR CUP AND LINER. REMOVED 28 + 3 SROM METAL HEAD. SURGEON REVISED CUP AND LINER ONLY. SROM CALCAR STEM AND SROM SLEEVE REMAINED IMPLANTED. AN SROM 40 MM + 6 HEAD IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10504472 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND PAIN. REVISION NOTES REPORTED SMALL AMOUNT OF CLOUDY SEROUS FLUID WITHIN THE BURSA AND DEEP TISSUES OF HIP CONSISTENT WITH SEROMA AND INFECTED SEROMA. PRIOR TO REVISION, THERE WAS NOTED SIGNIFICANT LOWER EXTREMITY EDEMA, SWELLING AND INABILITY TO AMBULATE. DOI: (B)(6) 2017 (HEAD & LINER); DOI: (B)(6) 2001 (CUP, STEM & SLEEVE); DOR: (B)(6) 2017 RIGHT HIP.

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

  MAUDE report 9564513 ↗
• InjuryDec 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD WAS REVISED TODAY AS THE COMPETITORS DUAL MOBILITY CONSTRUCT CONTINUOUSLY DISLOCATED. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9417734 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. UNKNOWN ORIGINAL SURGERY DATE. DOI: UNKNOWN; DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8741115 ↗
• InjuryApr 25, 2019Material Deformation; Material Deformation

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES LOOSENING OF CUP, METAL WEAR, AND METALLOSIS.

  Patient problems: Tissue Damage

  MAUDE report 8549992 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR, DISLOCATION WITH OPEN AND CLOSED REDUCTION AND LOOSENING OF STEM. DOI: (B)(6) 2004; DOR: (B)(6) 2006; (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 8505677 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN, ADHESIVE CAPSULITIS AND POLY WEAR. IT WAS ALSO STATED THAT THE ANERVERSION OF THE STEM WAS CHANGED TO SLIGHTLY ANTEVERTING. THERE IS NO SIGNS OF LOOSENING BUT IT LOOKED LIKE THE Z-CONE HAD SUBSIDED. THE POLY APPEARED TO BE WEAR. PATIENT HAD DISLOCATED OUT THE FRONT THE FIRST TIME SLIGHTLY OVER RETROVERTED HER AND SO DECIDED TO DISLODGE THE SROM STEM AND THEN RE-IMPACTED IT IN ABOUT PROBABLY 5 TO 10 DEGREES OF MORE ANTEVERSION. UPDATED PRODUCT CODES AND LOT NUMBERS.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8505418 ↗
• InjuryNov 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION RELATED TO PAIN.

  Patient problems: Pain

  MAUDE report 8045774 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, PAIN, AND POLY WEAR. DOI: 2000; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Osteolysis; Pain

  MAUDE report 7905737 ↗
• InjuryJul 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7713985 ↗
• InjuryMay 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES HIP DISLOCATED AND FEMORAL HEAD WAS REPLACED. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7525687 ↗
• InjuryMar 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE SURGEON'S PATIENT PRESENTED PAIN IN HER RIGHT HIP. AFTER OPENING HER RIGHT CAPSULE, HE COULD SEE A FAIR AMOUNT OF METALLOSIS IN THE FEMORAL/TRUNION AREA OF THE CONSTRUCT. DOI: UNKNOWN; DOR; (B)(6) 2018; RIGHT HIP.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7338174 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS PAIN, IT WAS ALSO INDICATED THAT LINER WAS VERY WORN.

  Patient problems: Pain

  MAUDE report 7006890 ↗
• InjuryJul 26, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6743557 ↗
• InjuryJul 26, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6743536 ↗