S-ROM 52-2034Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295170846), received between Jun 25, 2018 and Sep 24, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Device Dislodged or Dislocated

  It was reported that the implant was removed due to dislocation of the hip. There was no patient consequence and no surgical delay.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Left Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50886870 ↗
• InjurySep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED THEIR TRIPOLAR COMPETITOR CUP. DOCTOR REPLACED THE COMPETITOR CONSTRAINED LINER AND A NEW 32+12 METAL HEAD. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23028169 ↗
• InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 21546996 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT AND THE HEAD BALL WAS EXCHANGED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19579082 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 18788091 ↗
• InjuryNov 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO PAINFUL AND DISLOCATED RIGHT HIP. PREVIOUS SURGERY DATE AND LOCATION UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2021. (RIGHT HIP).

  Patient problems: Joint Dislocation; Pain

  MAUDE report 12853001 ↗
• InjuryJul 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED BACK ON (B)(6) 2020 BY A SURGEON AT (B)(6). THE CASE NUMBER FOR THE MDR IS 92249. DURING THAT REVISION, THE SROM HEAD WAS CHANGED FROM A 28MM TO A 32MM HEAD. THE PATIENT WAS IMPLANTED WITH A STRYKER CUP, SO THE LINER CHANGE WAS FROM A 28 TO 32MM LINER. UNFORTUNATELY, THE HIP WAS STILL DISLOCATING AND THE SURGEON FELT THE PATIENT NEEDED TO HAVE THEIR ACETABULUM REVISED. HE REVISED THE CUP TO A ZIMMER BIOMET G7 DUAL MOBILITY CONSTRUCT. HE WANTED TO KEEP THE SROM STEM AND SLEEVE IMPLANTED, SO HE OPTED TO USE OUR 28MM FEMORAL HEAD WITH THE DUAL MOBILITY LINER FROM ZIMMER BIOMET. A TRIAL REDUCTION WAS PERFORMED WITH A 28MM +9 HEAD AND FOUND TO BE STABLE. THE REAL IMPLANTS WERE OPENED AND INSERTED. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2020. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12246221 ↗
• InjuryFeb 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURALOC SHELL/ LINER AND SROM STEM/ HEAD WERE REMOVED FOR INFECTION AND CHRONIC DISLOCATION. STEM AND SHELL IMPLANTATION DATE ARE UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 9749957 ↗
• InjuryOct 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON STATED THAT PATIENT WAS DISLOCATING AND PREOPERATIVELY HE PLANNED TO REMOVE PERIPHERAL SCREWS (ONE SEEMED TO BE FLOATING IN CAPSULE BASED ON FILM HE SHOWED IN OFFICE). THE SURGEON STATED HE PLANNED TO REMOVE POLY AND FEMORAL HEAD TO REGAIN STABILITY IN HIP. DURING THE CASE, TWO PERIPHERAL PINS WERE REMOVED (ONE FLOATING WITHIN CAPSULE AND THE SECOND FROM THE POLY IN THE SROM CUP). THE SURGEON THEN REMOVED POLY AND FEMORALHEAD (32 10D & 32 +12 FEMORAL HEAD), INSERTED +9 32MM FEMORAL HEAD WITH 32 NEUTRAL POLY DIAL LINER. ORIGINAL IMPLANT DATE UNKNOWN. DOI: 8 YEARS AGO, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9151736 ↗
• InjuryAug 2, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SALES REP WAS CONTACTED BY A COMPETITIVE REP THAT THE SURGEON WAS GOING TO WASH OUT AN INFECTED HIP THAT THE DR DID AT BEAUMONT ROYAL OAK APPROXIMATELY 14 YEARS AGO AND THAT THE SURGEON WOULD NEED A SROM HIP BALL. BEFORE THE CASE STARTED I SPOKE WITH THE SURGEON AND HE SAID THAT HE COULD NOT ACCESS AND PREVIOUS CHART INFORMATION ON THIS PATIENT TO FIND IMPLANT NOTES. THE DR. EXPLANTED A SROM 32 MM + 12 HIP BALL THAT HAD VERY BAD REUNION WEAR AND WAS CORRODED IN THE TAPER. NO CAT # OR LOT # INFORMATION COULD BE RECORDED. THE STEM AND SLEEVE WERE LEFT IN SIRI AND THE CUP WAS STRYKER¿S. A NEW 32 MM HIP BALL WAS IMPLANTED. DOI: 14 YEARS AGO. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8857146 ↗
• InjuryFeb 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2006, DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8349400 ↗
• InjuryOct 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8005850 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON REMOVED A DURALOC 64 MULTI HOLE CUP AND CONSTRAINED LINER. PATIENT IS A CHRONIC DISLOCATOR. HE REMOVED THE CUP AND IMPLANTED A NEW ONE IN A DIFFERENT POSITION THAT WILL HOPEFULLY RESULT IN A BETTER STABILITY. THEY COULD NOT READ THE NUMBERS ON THE CUP. DOI: (B)(6) 2018 HEAD,LINER AND LOCKING RING; DOI: UNKNOWN - CUP; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7788973 ↗
• InjuryJul 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 7726571 ↗
• InjuryJul 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO REPORTED THAT THE SURGEON REMOVED THE COMPETITOR CUP AND DEPUY 32 MM +12 FEMORAL HEAD, AND RE-IMPLANTED A 36 MM +0 HEAD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7669288 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2014; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7634404 ↗