S-ROM 52-2022Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295170778), received between Oct 11, 2018 and Feb 25, 2026 — classified as 17 injuries, 1 malfunction.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED HIP. THERE WAS NO DELAY, AND NO HARM TO PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24442642 ↗
• InjuryDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT THA SURGERY ON HIP JOINT WITH SROM AND DURALOC IN QUESTION. THE PRODUCTS DETAILS ARE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, DISLOCATION WAS CONFIRMED. THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Joint Dislocation

  MAUDE report 23703691 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD SEVERE HIP DYSPLASIA AND HAD BOTH OF HER HIPS REPLACED BY SURGEON. BECAUSE OF HER HIP DYSPLASIA THE PATIENT OVER THE LAST 2 YEARS BECAME LAX AND HAD A LEG LENGTH DESCREPENCY. SURGEON REVISED HER SHORT SIDE AND EXPLANTED A 16X11 30STD NECK SROM AND IMPLANTED A 16X11 36+6 SROM STEM WHICH PROVIDED THE PATIENT WITH ADDITIONAL LEG LENGTH AND OFFSET. THE SROM SLEEVE, ACETABULAR CUP AND LINER WERE LEFT IN SITU. NO ADVERSE EVENTS AS THE RESULT OF OUR PRODUCTS. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 21997427 ↗
• InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR THE LEFT HIP JOINT WITH THE HEAD AND LINER IN QUESTION. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED TO REPLACE THE HEAD AND LINER IN QUESTION DUE TO DISLOCATION. THE SURGEON MENTIONED THAT DISLOCATION IS LIKELY TO OCCUR DUE TO LINER WEAR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19760604 ↗
• InjurySep 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6), 2000, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT REPEATEDLY DISLOCATED. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY WAS PERFORMED ON (B)(6), 2023, TO REMOVE THE STEM, THE LINER AND THE SCREWS OF THE CUP. AFTER THE TRIAL, THE LINER, THE STEM AND THE HEAD WAS REPLACED. THE REASON FOR THE REVISION IS DISLOCATION DUE TO IMPINGEMENT. DOI: MAY 31, 2000. DOR: (B)(6), 2023. UNKNOWN HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17689356 ↗
• InjurySep 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE COMPETITOR CUP, S-ROM. COMPETITOR CONSTRAINED DISLOCATED. REV NECESSARY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 15426770 ↗
• InjuryAug 24, 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: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15283655 ↗
• InjurySep 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT THE THA SURGERY FOR LEFT HIP AT ANOTHER HOSPITAL. ALTHOUGH THERE WAS NO PARTICULAR PROBLEM AFTER THE SURGERY, THE PATIENT VISITED THE HOSPITAL ((B)(6) HOSPITAL) BECAUSE OF REPEATED DISLOCATION THIS YEAR. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY. IN THE REVISION SURGERY, A CUP AND A STEM WERE REPLACED WITH NEW ONES. BECAUSE THE HOSPITAL DIDN¿T HAVE THE SAME PRODUCT AS THE LINER WHICH HAD BEEN IMPLANTED IN STOCK, THE LINER WAS KEPT USING AS IT WAS. WHEN THE SURGEON CHECKED THE LINER, THE LINER IN THE DISLOCATED DIRECTION WAS BROKEN. THE SURGEON COMMENTED THAT THE BREAKAGE OF THE LINER MIGHT BE ONE OF THE CAUSES OF FREQUENT DISLOCATION. THE REVISION SURGERY WAS COMPLETED WITH NO PROBLEM. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12519415 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Pain

  MAUDE report 12318409 ↗
• InjuryJan 20, 2021Off-Label Use; Off-Label Use

  DR HAS UNFORTUNATELY HAD TO PERFORM SEVERAL REVISIONS WITH THIS PATIENT. THE ONLY ONE I WAS ABLE TO PULL UP RECORDS FOR WAS THE MOST PREVIOUS REVISION DONE IN (B)(6) 2020. THIS PATIENT SUFFERS FROM EHLERS DANLOS SYNDROME. DR HAD AN SROM STEM AND 22MM HEAD IN, WITH A COMPETITOR ACETABULAR COMPONENT. THE PATIENT WAS FEELING SOME IMPINGING OF THEIR HIP, SO DR (B)(6) OPTED TO CHANGE OUT THE COMPETITOR LINER, AS WELL AS THE SROM STEM AND HEAD. A 16 X 11 X 150 30+4 STEM WAS REMOVED AND A 16 X 11 X 150 36 +6 WAS IMPLANTED. THE SROM SLEEVE WAS LEFT ALONE. A TRIAL REDUCTION WAS PERFORMED WITH A 36MM +0 HEAD AND FOUND TO BE STABLE. DR BELIEVED THE ADDITIONAL OFFSET HELPED WITH THE PATIENTS IMPINGING ON THEIR ACETABULAR COMPONENT. THE REAL 36MM +0 CERAMIC HEAD WAS OPENED AND IMPLANTED. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT HIP.

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

  MAUDE report 11201647 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD IN LINE OR EXCHANGE DUE TO INSTABILITY. COMPETITORS CUP WAS ALREADY IN PLACE. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11193424 ↗
• InjuryMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS HIP DISLOCATED, SO HE REVISED THE STEM AND ADDED MORE OFFSET TO INCREASE HER STABILITY. DOI: (B)(6) 2014. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9861615 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE HIP. JUST NEEDED A HEAD FROM US AS THE CUP WAS A COMPETITORS. DOI: (B)(6) 2016; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9688820 ↗
• InjuryJan 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A REVISION SURGERY WHEREIN THE STEM, PROXIMAL SLEEVE AND LINER WERE REVISED. REASON FOR REVISION IS UNKNOWN. DOI: (B)(6) 2011; DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9640207 ↗
• InjuryJun 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION AND INSTABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8682732 ↗
• InjuryMay 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP REVISION, DISLOCATION. THE SURGEON ALSO REMOVED FROM PATIENT, PRODUCT CODE 1014-36 BUT SEEMS THE PRODUCT IS NOT RECOGNIZED BY THE SYSTEM. I¿LL TRY TO ATTACHED A DOCUMENT WITH THE ORIGINAL STICKERS FROM PRODUCTS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. PATIENT STATUS/OUTCOME/CONSEQUENCES?NO.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8577690 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED IN 1991 VIA (B)(6) BY USING SROM (DATE OF PRIMARY SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE PATIENT COMPLAINED THE PAIN AND IT WAS CONFIRMED CENTRAL MIGRATION OCCURRED IN 2018. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE HEAD (P/N: 522022), THE STEM (P/N: 526516L), THE BIPOLAR CUP (P/N: UNKNOWN) TO THE CUP (MANUFACTURED BY (B)(4)). THE SLEEVE WAS RETAINED. THE SURGERY WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT IS SAME AS (B)(4).

  Patient problems: Pain

  MAUDE report 8468933 ↗
• MalfunctionOct 11, 2018Naturally Worn; Naturally Worn

  WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957872 ↗