S-ROM 52-2032Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295170822), received between Sep 14, 2017 and Jul 7, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISING A CONSTRAINED LINER DISLOCATION. REPLACING HEAD AND LINER DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25735059 ↗
• InjuryOct 4, 2024Adverse 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 UNSTABLE HIP AND CONVERTED TO A CONSTRAINED LINER. THERE WAS NO DELAY, NO HARM TO PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 20370380 ↗
• InjuryMar 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED HER HIP. SURGEON REPLACED HEAD BALL AND CONSTRAINED LINER. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16551729 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP. PREVIOUS SURGERY DATE AND LOCATION IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15282606 ↗
• InjuryJun 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF THA-SROM STEM ON REFLECTION OF CUP AND LINER. PATIENT SUFFERED MULTIPLE FALLS. LINER WAS FOUND TO BE DISLOCATED FROM CUP IN SURGERY, CHANGED LINER AND WHEN UP IN HEAD LENGTH. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14699455 ↗
• InjuryDec 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED APPROXIMATELY 18 YEARS AGO. THE PATIENT DID WELL UNTIL A RECENT FALL AT THE GYM. SHE FELL DOWN ON HER HIP AND DISLOCATED HER RIGHT HIP WHILE WORKING OUT. A CLOSED REDUCTION WAS DONE WITH SUCCESS BUT CONTINUED TO DISLOCATE OVER THE LAST FEW MONTHS. THE DOCTOR DECIDED TO REVISE HER HIP WHERE HE REPLACED THE LINER IN THE ZIMMER ACETABULAR CUP AND EXPLANTED THE SROM HIP BALL. THE SLEEVE AND THE STEM WERE LEFT IN SITU. A NEW CERAMIC FEMORAL HIP BALL WAS IMPLANTED ALONG WITH A NEW ZIMMER LINER FOR THE CUP. NO NOTES, X-RAYS, OR OPERATIVE REPORTS TO SHARE. THE ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: 18 YEARS AGO; DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Fall; Joint Dislocation

  MAUDE report 12960849 ↗
• InjurySep 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REPLACED LINER AND FEMORAL HEAD. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12546905 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS. DOI: (B)(6) 2008; DOR: (B)(6) 2011; (LEFT SIDE). UPDATE: 12/14/2012 - LITIGATION RECEIVED 11/14/2012 AND ALLEGES PATIENT EXPERIENCED SCIATICA, HIP AND BACK PAIN, AND GENERAL HIP DISCOMFORT. IT IS ALSO ALLEGED THAT SAID FAILURE INCLUDED BUT WAS NOT LIMITED TO A BREAKDOWN AND/OR DAMAGE OF THE POLY LINER, RESULTING IN METAL-ON-METAL ARTICULATION. IT IS FURTHER ALLEGED PATIENT'S SURGICAL FINDINGS INCLUDED A CATASTROPHIC POLY FAILURE WITH METAL ON METAL ARTICULATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. PATIENT IS A RESIDENT OF (B)(6). UPDATE AD 1 NOV 2018: WPC 2269-2011 HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND IMPLANT RECORDS. PPF HAS NO ALLEGATION REPORTED. THE PATIENT NAME WAS UPDATED AND ADDED THE PATIENT DATE OF BIRTH AND LAWYER. DOI: (B)(6) 2008 ; DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Pain

  MAUDE report 12407012 ↗
• InjuryMar 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED VIA THA AT ANOTHER HOSPITAL ((B)(6) HOSPITAL). THE DATE OF THE PRIMARY SURGERY WAS UNKNOWN. THE USED IMPLANTS WERE, THE CUP AND THE LINER WERE MANUFACTURED BY ZIMMER BIOMET, THE STEM WAS DEPUY'S PRODUCT (SROM SERIES). IT WAS REPORTED THAT THE PATIENT FELL AND HAD DISLOCATION. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY. IN THE REVISION, THE SURGEON FOUND THAT THE LOCKING RING OF THE LINER HAD CAME OFF AND DISLOCATED. THE CUP AND STEM WERE NOT LOOSENED. THE SURGEON REPLACED THE LINER AND HEAD WITH THE NEW ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REVISION SURGICAL TIME IS ABOUT 90 MINUTES.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11398493 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS THIGH PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10301624 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS AN 11-YEAR-OLD HIP BECOME UNSTABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10191971 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. DOI: (B)(6) 2016. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Disorder

  MAUDE report 9418671 ↗
• InjuryOct 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER AND HEAD WERE EXCHANGED FOR DISLOCATION. DOI: (B)(6) 1995; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9261749 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED LEFT HIP REMOVAL OF IMPLANTS AND SPACER PLACEMENT. SURGERY(B)(6) 2919 PATIENT STATUS/OUTCOME/CONSEQUENCES: UNKNOWN, 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, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, ACTIVITY LEVEL HIGH, (B)(4); DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4); DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4); DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4); DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4); DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. 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: No Code Available; Unspecified Infection

  MAUDE report 9011383 ↗
• InjuryMay 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT COMPLAINED ABOUT DISLOCATING. PATIENT WAS BROUGHT TO THE OR AND A 32MM +0 HEAD WAS REMOVED FOLLOWED BY A 48/32MM +4 10 DEGREE LINER AS WELL AS THE HOLE ELIMINATOR IN THE ACETABULAR CUP. A 48/28MM +4 NEUTRAL CONSTRAINED LINER WAS IMPACTED INTO THE ORIGINAL CUP AND A CERAMIC 28MM +0 HEAD WAS IMPLANTED ON THE FEMORAL STEM. PATIENT WAS PUT IN ROM AND BEGAN CLOSING. DOI: 2007; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8645880 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AFTER FIRST REVISION. LINER WAS NON METAL AND STEM WAS ALREADY REPORTED ON 1ST PC. (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8528655 ↗
• InjuryFeb 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGED DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8374112 ↗
• InjuryDec 20, 2018Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  LITIGATION ALLEGES DISLOCATION AND IMPLANT NOISE. DOI: (B)(6) 2010; DOR: (B)(6) 2013; (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available; Test Result

  MAUDE report 8185926 ↗
• InjuryNov 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES PSEUDOTUMOR, DISLOCATION WITH CLOSED REDUCTION, AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; Test Result; Tissue Damage

  MAUDE report 8117001 ↗
• InjuryMay 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS REOCCURRING DISLOCATION. DOI: 2004; DOR: (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7511917 ↗
• InjuryApr 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. SECOND SIDE OF BILATERAL REVISION. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2011 DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7439767 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS FUNGAL INFECTION. SURGEON DECIDED TO PERFORM A I&D AND CHANGE OUT THE LINER AND HEAD. SURGEON ALSO PACKED ANTIBIOTIC BEADS TO FIGHT THE FUNGAL INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7398890 ↗
• InjuryJan 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN. (B)(6) 2018. UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7227309 ↗
• InjuryNov 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION DUE TO FALL.

  Patient problems: Joint Dislocation

  MAUDE report 7040211 ↗
• InjuryOct 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT HIP.

  Patient problems: Pain

  MAUDE report 6961401 ↗