S-ROM 52-2029Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295170808), received between Jun 28, 2017 and Apr 7, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (25 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A DISLOCATION. THE COMPETITOR'S CUP WAS REMOVED AS WELL AS THE 20X15X165 SROM STEM AND 28MM SROM HEAD. DOCTOR WANTED TO REMOVE THE STEM IN ORDER TO PROVIDE MORE ROOM AND VISIBILITY TO THE ACETABULUM. A NEW GRIPTION CUP WAS IMPLANTED, A NEW 20X15X165 STEM, AND A 36MM +6 CERAMIC HEAD. THE HIP WAS REDUCED AND STABILITY WAS CONFIRMED. THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES, DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24806595 ↗
• InjuryApr 7, 2026Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: WHAT WERE THE EXACT ALLEGATIONS AGAINST THE LINER AND FEMORAL HEAD? : WEAR AND TEAR OF THE IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 24801033 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP REPLACEMENT 30+ YEARS AGO. PATIENT HAS NOW BEEN EXPERIENCING INSTABILITY AND PAIN AND NEEDED A REVISION. ALSO THERE WAS A LOOSENING OF STEM AT NON-CEMENTED INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24691810 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D HEAD EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24489567 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER HEAD WAS EXCHANGED DUE TO PRESUMED INFECTION. DOI- (B)(6) 2025. DOR- (B)(6) 2026. AFFECTED SIDE-UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24084770 ↗
• InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REVISION OF A LEFT TOTAL HIP FOR INSTABILITY. THE 23-YEAR-OLD HIP WAS REVISED FOR POLYETHYLENE WEAR AND INSTABILITY. RECENT DISLOCATION OF FEMORAL HEAD OUT OF THE ACETABULAR COMPONENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23435498 ↗
• InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A LEFT TOTAL HIP FOR INSTABILITY. 23-YEAR-OLD HIP WAS REVISED FOR POLYETHYLENE WEAR AND INSTABILITY. RECENT DISLOCATION OF FEMORAL HEAD OUT OF THE ACETABULAR COMPONENT. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23435434 ↗
• InjuryMay 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENTS CURRENT PINNACLE CONSTRAINED LINER DISLOCATED. THE FEMORAL HEAD DISLOCATED OUT OF THE CONSTRAINED LINER. REMOVED THE CONSTRAINED LINER AND FEMORAL HEAD AND REPLACED. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22078664 ↗
• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LEFT HIP DISLOCATION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21718631 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-DEPUY SYNTHES CUP WAS REMOVED DUE TO INSTABILITY. A DEPUY SYNTHES FEMORAL HEAD HAD BEEN IMPLANTED AND WAS ALSO REVISED. NEW SROM HEAD WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21312431 ↗
• InjuryMar 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: DISLOCATION & OSTEOLYSIS.

  Patient problems: Joint Dislocation; Osteolysis

  MAUDE report 18980360 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS. DATE OF IMPLANT: (B)(6) 2000. DATE OF REVISION: (B)(6) 2024. (LEFT HIP). TREATMENT: HEAD, LINER, AND CUP WERE REVISED.

  Patient problems: Osteolysis

  MAUDE report 18912767 ↗
• InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT'S HIP REVISION DUE TO RECURRENT DISLOCATION OF PINNACLE CONSTRAINED LINER. SURGEON ELECTED TO GIRDLESTONE PATIENT. PINNACLE CONSTRAINED LINER AND LOCKING RING AS WELL AS SROM STEM AND HEAD WERE REMOVED. A 50X32 PINNACLE LINER WAS IMPLANTED. THE SROM SLEEVE REMAINED IN PLACE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17070086 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON EXPLAINED THAT THE PATIENT MAY HAVE SOME POLY WEAR AND OSTEOLYSIS DUE TO METALLOSIS. THE COMPONENTS THAT WERE IMPLANTED WERE A DEPUY SROM STEM AND FEMORAL HEAD, BUT THE ACETABULAR COMPONENTS WAS A STRYKER VITALOCK. HE WAS NOT SURE OF WHO THE INITIAL IMPLANTING SURGEON WAS, OR WHEN THE CASE WAS DONE. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A HEAD AND LINER EXCHANGE. THE HEAD THAT WAS REMOVED WAS A 28MM +6 METAL BALL. THE CUP WAS ABLE TO ACCEPT A 32 LINER AS WELL, SO THE SURGEON CHANGED THE STRYKER LINER TO A 32 AND THEN HE TRIALED A 32 +6 HEAD TO ASSESS STABILITY. STABILITY WAS CONFIRMED AND A 32 +6 HEAD WAS OPENED AND IMPLANTED. CLOSING PROCESS BEGAN. ORIGINAL IMPLANT DATE UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 16378426 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS LINER POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 2002. DATE OF REVISION: (B)(6) 2022, (LEFT HIP) . TREATMENT: FEMORAL HEAD AND ACETABULAR LINER WERE REVISED.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 15401170 ↗
• InjuryApr 26, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO INSTABILITY. ORIGINAL IMPLANT DATE UNKNOWN . THE PATIENT HAD A COMPETITOR CUP IMPLANTED WITH AN SROM STEM. SHE REMOVED A 28,+6 COCR SROM HEAD. SHE THEN PUT IN A COMPETITOR LINER WITH A 36,+9 SROM COCR HEAD. PATIENT HIP WAS STABLE AFTER THIS. WAS NOT ABLE TO OBTAIN LOT NUMBERS FROM HEAD REMOVED DUE TO HOSPITAL PROTOCOLS. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14206910 ↗
• InjuryNov 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OPERATIVE NOTES WERE REVIEWED AND INDICATED THAT ON (B)(6) 2021, THE PATIENT HAD A RIGHT REVISION TOTAL HIP TO ADDRESS DISLOCATION, INSTABILITY, ECCENTRIC POLYETHYLENE WEAR. DURING THE REVISION THE SURGEON OBSERVED EFFUSION, FOREIGN BODY SYNOVITIS. THERE WAS SOME CORROSION ON THE TRUNNION. THE FEMORAL HEAD AND LINER WERE REVISED. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 12752507 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2003, THE PRIMARY SURGERY WAS PERFORMED WITH THE STEM, HEAD AND CUP. THE PATIENT WAS IN HIS 30S AT THE TIME. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED DUE TO PAIN. IN THE REVISION, THE HEAD AND CUP WERE REMOVED TOGETHER. WHEN THE SURGEON TRIED TO REMOVE THE STEM, THE STEM COULDN¿T BE REMOVED. WHEN THE SURGEON GRABBED THE STEM NECK, THE STEM NECK WAS DAMAGED. THE SURGEON GAVE UP REMOVING THE STEM AND MOVE TO HEAD SELECTION, BUT THERE WERE FEW VARIATIONS OF HEADS THAT COULD BE SELECTED. THE PATIENT WAS YOUNG IN HIS 50S, BUT THE SURGEON HAD NO CHOICE BUT TO CHOOSE A METAL HEAD. THE PLACEMENT POSITION OF THE CUP ALSO NEEDED TO BE ADJUSTED ACCORDING TO THE STEM CURRENTLY IN PLACE, AND THUS, COULD NOT BE PLACED AT THE OPTIMUM POSITION. THE MOVEMENT OF THE IMPLANT IS SLIGHTLY TIGHT, WHICH IS WORRISOME. CONSEQUENTLY, OPTIMAL TREATMENT COULD NOT BE PROVIDED. THE SURGERY WAS COMPLETED WITH MORE THAN 30MINUTES DELAY. THE SURGEON COMMENTED AS FOLLOWS. WITH HEAD VARIATION, HE WAS ABLE TO PROVIDE OPTIMAL TREATMENT FOR PATIENTS WITHOUT INCREASING OPERATION TIME. ALTHOUGH IT IS A DISCONTINUED PRODUCT, IT IS THE PRESENT TIME TO MAKE A REVISION, AND IT SEEMS T

  Patient problems: Pain

  MAUDE report 12288636 ↗
• InjuryApr 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2000, THE PATIENT HAD A RIGHT PRESS-FIT ARTHROPLASTY TO ADDRESS PAIN, DISCOMFORT AND STIFFNESS SECONDARY TO OSTEOARTHRITITS/LABRAL CALCIFICATION. DEPUY COMPONENTS, INCLUDING SROM STEM/SLEEVE WERE USED DURING THIS PROCEDURE. TWO SCREWS WERE PLACED. MEDICAL RECORDS FROM (B)(6) 2021 NOTE THE PATIENT HAS BEEN EXPERIENCING RIGHT HIP INSTABILITY. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY, SECONDARY TO ECCENTRIC POLYWEAR WITH POLYETHYLENE SYNOVITIS AND RECURRENT SUBLUXATION. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. THE INDICATIONS FOR SURGERY INCLUDED PAIN AND ¿PROBABLY HAS SOME IMPINGEMENT WITH SECONDARY POLY WEAR.¿ THE SURGEON REPORTED FINDING ECCENTRIC POLYWEAR, WITH SYNOVITIS. THE STEM AND CUP HAD LESS THAN OPTIMAL ANTEVERSION AND WERE REVISED. A CYST WAS NOTED IN THE ILIOPSOAS TENDON SHEATH AND WAS DEBRIDED. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Joint Dislocation; Joint Laxity; Pain; Synovitis

  MAUDE report 11619715 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT THE PATIENT WAS COMPLAINING OF HIP PAIN. PATIENT WAS UNABLE TO TELL WHO PERFORMED THE ORIGINAL PROCEDURE AND WHERE IT WAS PERFORMED. AFTER REVIEWING THE PATIENTS XRAYS, SURGEON FELT THE ACETABULAR COMPONENTS NEEDED TO BE REVISED. THE FEMORAL COMPONENTS SEEMED TO BE STABLE AND APPROPRIATELY POSITIONED. THE ACETABULUM WAS AN OLD SROM SUPER CUP. I WAS UNABLE TO READ ITEM AND LOT NUMBERS ON THE IMPLANTS. UNABLE TO IDENTIFY THE CUP, LINER AND PERIPHERAL SCREW SIZES. ONCE THE CUP WAS REMOVED, SURGEON REAMED THE ACETABULUM TO A 58, AND IMPLANTED A 58MM MULTI-HOLE GRIPTION CUP. A NEUTRAL 58X36MM LINER WAS IMPLANTED AND A 36MM +6 HEAD WAS TRAILED. THE HIP WAS FOUND TO BE STABLE AND OF APPROPRIATE LENGTH, SO THE REAL HEAD WAS OPENED AND IMPLANTED. THE CLOSING PROCESS BEGAN. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10819538 ↗
• InjuryNov 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS DISLOCATION DATE OF IMPLANTATION: (B)(6) 2007; DATE OF REVISION: (B)(6) 2008; (RIGHT HIP). TREATMENT: FEMORAL HEAD, ACETABULAR LINER, AND FEMORAL STEM REVISED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10801970 ↗
• InjuryJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT STATUS POST LEFT TOTAL HIP REVISION ONE WEEK PRIOR. THE PATIENT FELL AND DISLOCATED LEFT HIP, THE SURGEON OPTED FOR A HEAD AND LINER EXCHANGE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10344568 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT HAD THEIR INITIAL HIP DONE BY SURGEON AT (B)(6). THE CASE WAS DONE ROUGHLY 25-30 YEARS AGO, SO HE WAS UNABLE TO PULL UP RECORDS OF EXACTLY WHEN THE CASE WAS DONE. THE SURGEON AT THE TIME WAS USING S-ROM STEMS, BUT COMPETITOR VITALOCK ACETABULAR COMPONENTS. THE REVISION WAS BEING PERFORMED DUE TO PATIENT DISCOMFORT. THE SURGEON BELIEVED THEIR CUP MAY BE LOSE, BUT UPON EXAMINATION IT APPEARED TO BE STABLE. HE OPTED TO CHANGE THE LINER GIVING HIM A BIGGER HEAD OPTION AND ALLOWING HIM TO ADJUST THE POSITION OF THE LINER. A 28MM +6 METAL HEAD WAS REMOVED. AFTER INSERTING THE NEW LINER, A TRIAL REDUCTION WAS PERFORMED WITH A 32MM +9 HEAD. THE SURGEON BELIEVED A LONGER NECK WOULD HELP TO INCREASE STABILITY. HE ENDED UP DECIDING TO GO WITH A 32MM +12 METAL HEAD. THE IMPLANT WAS OPENED AND INSERTED. THE CLOSING PROCESS BEGAN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Discomfort; Joint Dislocation; No Code Available

  MAUDE report 10112906 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF GROIN PAIN AS COMMENTED BY THE SURGEON, THE SURGEON REVISED THE LINER. HE REPLACED IT WITH A NEW 32X54N DURALOC MARATHON LINER. NO OTHER INFORMATION AVAILABLE. DOI: (B)(6) 2000. DOR: (B)(6) 2020. LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10103150 ↗
• InjuryApr 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION AND STABILITY ISSUES. SROM STEM WELL FIXED AND THE CUP/LINER COULD NOT BE IDENTIFIED. DO NOT THINK THE CUP/LINER ARE DEPUY COMPONENTS. DOI: (B)(6) 2001. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9986315 ↗