S-ROM 52-2028Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295170792), received between Aug 10, 2017 and Sep 5, 2025 — classified as 39 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN EARLY 2025, THE INFECTED AREA WAS CLEANED BY DEBRIDEMENT, BUT THE CONDITION WAS NOT COMPLETELY CURED. SURGEON DECIDED AGAINST COMPLETE REMOVAL FOR THE TIME BEING, AND BECAUSE THE LINER WAS WORN, HE SAID HE WOULD MONITOR THE SITUATION AND CONSIDER REPLACING THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 22979365 ↗
• InjuryDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY WEAR AND DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20818372 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIP INSTABILITY, 56 DURALOC CUP,56 10 DEGREE LINER, 56 DYNAMIC LOCKING RING, 28 +0 11/13 S-ROM HEAD REMOVED. NO DELAY IN CASE WHILE REMOVING OLD COMPONENTS. DOI- UNKNOWN, DOR- ON (B)(6) 2024, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19606268 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2023, FOLLOWING A DISLOCATION. SURGICAL DELAY IS UNKNOWN. THIS REPORT IS FOR AN S-ROM*HEAD FEMORAL COCR 28+0. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 17288514 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH SROM HIP AND STRYKER VITALOCK CUP. PATIENT WAS BEING REVISED DUE TO INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17215477 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005 PATIENT DEVELOPED A DEEP VEIN THROMBOSIS POSTOPERATIVELY. DOI: (B)(6) 2005; DOE: (B)(6) 2005; RIGHT HIP. THIS PC-(B)(4) IS A LINK OF PC-(B)(4).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17070114 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE INSTABILITY AND IMPLANT WEAR. DOI: (B)(6) 2003 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16495420 ↗
• InjuryJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF SROM/STRYKER MDM TOTAL HIP REPLACEMENT - PATIENT HAD A FALL AND DISLOCATED, CAUSED A DISASSOCIATION OF THE DUAL MOBILITY HEAD AND LINER. SURGEON WENT IN, WASHED OUT HIP , REPLACED DEPUY SROM HEAD AND STRYKER MDM LINER. LEFT TOTAL HIP - ORIGINAL SURGERY COMPLETED BY DR IN (B)(6) 2022, SPECIFICS UNKNOWN.

  Patient problems: Fall

  MAUDE report 16130665 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16094479 ↗
• InjuryJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP SURGERY ROUGHLY 20 YEARS AGO. THE SURGEON WAS UNSURE OF WHO THE SURGEON WAS, AND WHERE THE SURGERY TOOK PLACE. THE PATIENT WAS BEING REVISED DUE TO DISLOCATION. WHEN OPENING THE HIP, IT WAS DISCOVERED THE PATIENT WAS IMPLANTED WITH A 50X28 +4/10 LINER AND A METAL 28MM +0 HEAD. THE POLY WAS SHOWING SIGNS OF WEAR AT THE ELEVATED PORTION OF THE LINER. THE SURGEON OPTED TO IMPLANT A 50X32 +4/10 LINER TO ALLOW FOR A BIGGER FEMORAL HEAD. A TRIAL REDUCTION WAS PERFORMED WITH A 32 +0 AND FOUND TO BE STABLE. THE REAL FEMORAL HEAD WAS OPENED AND IMPLANTED. HIP WAS REDUCED AND STABILITY WAS CONFIRMED. CLOSING PROCESS BEGAN. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14623142 ↗
• InjuryMar 16, 2022Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR GRINDING AND SQUEAKING & ABNORMAL RADIOGRAPHIC EVALUATION - POLYWEAR (COMPETITOR LINER), AND OSTEOLYSIS BEHIND THE COMPETITOR CUP EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2000. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT HIP).

  Patient problems: Osteolysis; Pain; Physical Asymmetry

  MAUDE report 13789356 ↗
• InjuryFeb 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE IS UNKNOWN. PATIENT SUFFERED SEVERAL DISLOCATIONS SINCE 1999. SURGERY WAS SCHEDULED, HOWEVER, EMERGENCY SURGERY WAS PERFORMED WHEN PATIENT CAME INTO ER WITH A DISLOCATION. BIGGER (ZIMMER) CUP IMPLANTED WITH LIPPED LINER AND LARGER HEAD TO MATCH LINER, SAME NECK LENGTH USED. DOI: UNKNOWN; DOR: (B)(6) 2022 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13544184 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNSTABLE HIP DUE TO POLY WEAR. PER THE OP NOTE, IT WAS A 50MM DURALOC CUP WITH LOCKING RING, 28X50 +4N DURALOC LINER AND AN SROM 28+0 METAL HEAD. THE INSIDE OF THE HEAD LOOKED LIKE IT SAID SVH32 AND THE LINER HAD TN58N I THINK. THE NUMBERS WERE DAMAGED DURING EXTRACTION. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2001. DOR: (B)(6) 2021. (RIGHT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12697217 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME SLIGHTLY UNSTABLE 20 YEARS FOLLOWING THA. SURGEON EXCHANGED PINNACLE LINER AND SROM HEAD. STEM, SLEEVE, AND CUP REMAINED IMPLANTED. NO FURTHER INFORMATION AVAILABLE. NO IMPLANT RECORDS AVAILABLE. DOI: (B)(6) 2001 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12061918 ↗
• InjuryJun 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. PATIENT SUFFERED A HIP DISLOCATION OF SROM HIP AND CONSTRAINED LINER. SURGEON WAS NOT AWARE OF THE PATIENTS PREVIOUS SURGICAL DATES OR REASONS FOR SURGERY. SURGEON FELT THIS PATIENT WAS DEALING WITH SOME HIP IMPINGEMENT OF THEIR +4/10 DEGREE CONSTRAINED LINER ON THE NECK OF THE SROM STEM. HE FELT THEY WOULD BENEFIT FROM CONVERTING THE LINER TO JUST A +4 NEUTRAL CONSTRAINED LINER. HE ALSO FELT THE PATIENT WOULD BENEFIT FROM REPLACING THE STEM SO HE COULD ADJUST THE VERSION A BIT. A TRIAL REDUCTION WAS PERFORMED WITH THE NEW STEM AND A +4 NEUTRAL CONSTRAINED LINER AND A 28MM +3 HEAD WAS FOUND TO BE SATISFACTORY. THE REAL LINER AND HEAD WERE OPENED AND IMPLANTED. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: (B)(6) 2021; (RIGHT HIP).

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

  MAUDE report 12003022 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER HIP REPLACED 20+ YEARS AGO AND HAD A REVISION DONE IN 2005 BY ANOTHER DR. ACCORDING TO CURRENT DR. THIS PATIENT RECENTLY BEGAN COMPLAINT OF PAIN IN HER LEFT HIP. THROUGH EXAMINATION AND TESTING (NO LABS OR DOCUMENTS AVAILABLE WITH RESULTS) IT WAS DETERMINED THIS PATIENT HAS ELEVATED CHROMIUM LEVELS. CURRENT DR. SCHEDULED THE PATIENT FOR A HIP REVISION WHERE HE DECIDED TO DO A HIP BALL EXCHANGE. THE SROM STEM, SROM SLEEVE, ARTHROPOR CUP AND LINER WERE LEFT IN SITU. DOI: UNKNOWN. DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11713251 ↗
• InjuryApr 1, 2021Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE SURGEON PERFORMED THIS PATIENT'S PRIMARY HIP PROCEDURE BACK IN 1995. PATIENT WAS IMPLANTED WITH SROM FEMORAL COMPONENTS, BUT COMPETITOR ACETABULAR COMPONENTS. THIS PARTICULAR PATIENT WAS SUFFERING FROM HIP INSTABILITY, SO THE SURGEON BELIEVED THEY WOULD BENEFIT FROM AN ACETABULAR REVISION. A 28MM +0 FEMORAL HEAD WAS REMOVED FROM THE SROM STEM, AND THE COMPETITOR ACETABULAR COMPONENT WAS REMOVED AS WELL. THE PATIENT'S HIP WAS REAMED UP AND PREPARED FOR A 58MM GRIPTION MULTI-HOLE CUP. A 58X36 +4 10 DEGREE LINER WAS IMPLANTED AND A TRIAL REDUCTION WAS PERFORMED WITH A 36MM +3 HEAD. THE HIP WAS FOUND TO BE STABLE, SO THE REAL FEMORAL HEAD WAS OPENED AND IMPLANTED. THE CLOSING PROCESS BEGAN. DOI: 1995, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11602137 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RIGHT LEG LENGTH WAS MUCH SHORTER THAN LEFT LEG. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 11332212 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACETABULAR REVISION AND STEM REVISION. THE CUP HAD MIGRATED MEDIALLY. THE CUP AND LINER WERE NOT DEPUY IMPLANTS AND WERE REVISED WITH COMPETITOR COMPONENTS. THE STEM WAS A 22 X 17MM CALCAR REPLACING S ROM STEM. THE S ROM SLEEVE WAS NOT REVISED AND WAS LEFT IN THE PATIENT. A NEW 22 X 17MM S ROM CALCAR BODY STEM WAS IMPLANTED AND A 28MM +3 CERAMIC HEAD. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10816298 ↗
• InjuryOct 23, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION TOTAL HIP REPLACEMENT; HOSPITAL (B)(6) 2020: REVISION DUE TO DISLOCATION AND INSTABILITY. CASE WILL LIKELY HAVE PREVIOUS REPORTS AS PREVIOUS REVISION (B)(4) HAS OCCURRED FOR INSTABILITY NECK OF SROM STEM NOTCHED DUE TO IMPINGEMENT WITH ACETABULAR COMPONENT. EVIDENCE OF MACROSCOPIC STAINING FROM METAL WEAR IMPINGEMENT OF FEMORAL STEM WITH ACETABULAR COMPONENT.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10727070 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE AT SAME FACILITY IN THE LAST 10 DAYS OR SO. WAS BROUGHT BACK FOR A HEMATOMA OF THE WOUND AND SURGEON REPLACED THE HEAD BALL. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Hematoma; No Code Available

  MAUDE report 10721797 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, IMPLANTED A PROSTALAC STEM. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10621916 ↗
• InjurySep 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DEALING WITH SOME DISLOCATION ISSUES. SURGEON HAD PERFORMED THEIR INITIAL OPERATION ABOUT 20 YEARS PRIOR, BUT WAS UNABLE TO GIVE ME THE EXACT DATE. THE CHARTING DID NOT GO BACK THAT FAR. SURGEON BELIEVED THE PATIENT WAS DEALING WITH INSTABILITY DUE TO POLY WEAR AND CUP POSITIONING. BACK THEN, SURGEON WOULD USE OUR SROM STEM AND FEMORAL HEADS, BUT IMPLANTED COMPETITOR ACETABULAR COMPONENTS. HE REMOVED THE 28MM +0 HEAD, AND REMOVED A 52MM COMPETITOR CUP. SURGEON REAMED THE ACETABULUM UP TO 58MM AND IMPLANTED A 58MM GRIPTION MULTI-HOLE CUP. HE OPTED FOR THE 58X36MM NEUTRAL LINER. A TRIAL REDUCTION WAS PERFORMED WITH A 36 +0 HEAD AND FOUND TO BE SATISFACTORY. THE REAL HEAD WAS OPENED AND IMPLANTED. THE CLOSING PROCESS BEGAN. DOI: 20 YEARS PRIOR, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10554266 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT CAME INTO SURGEON'S OFFICE RECENTLY WITH DISCOMFORT AND INSTABILITY IN HER RIGHT HIP. X-RAY REVEALED THAT THE STRYKER ACETABULAR CUP WAS MALALIGNED AND THE POLY WAS MOST LIKELY WORN OUT. SHE HAD HER HIP REPLACED 20+ YEARS AGO WHERE A SROM STEM AND A STRYKER VITALOK ACETABULAR CUP WAS IMPLANTED BY A SURGEON THAT WAS UNKNOWN. THE HOSPITAL STAFF NOR THE SURGEON KNEW WHO DID THE ORIGINAL SURGERY AND HAVE NO PREVIOUS RECORDS AVAILABLE FOR THIS PATIENT. SURGEON REPLACES THE SROM FEMORAL HEAD AND USED A ZIMMER CUP. THE LOT INFORMATION FOR THE EXPLANTED 28MM + 0 HIP BALL THAT WAS EXPLANTED WAS NOT LEGIBLE. THE LOT # ON THE FEMORAL STEM WAS NOT LEGIBLE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; No Code Available

  MAUDE report 10033076 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2003. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9176367 ↗