S-ROM 52-2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295170815), received between Jun 29, 2017 and Feb 23, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY DONE BY DR. HE WAS UNABLE TO PROVIDE ME WITH THE INITIAL IMPLANT DATE. THE PATIENT SUFFERED A DISLOCATION OF THEIR HIP, REQUIRING A HEAD AND LINER EXCHANGE. A 28+12 SROM HEAD WAS REMOVED AS WELL AS THE 58 PINNACLE DM SHELL. A NEW POLY WAS OPENED AND IMPLANTED. 36MM SROM HEADS WERE TRIALED AND A 36+9 SROM HEAD WAS FOUND TO BE STABLE. THE REAL HEAD WAS OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI- UNKNOWN, DOR- UNKNOWN, AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24421665 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15716632 ↗
• InjuryMar 8, 2022Adverse 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) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 13692884 ↗
• InjuryDec 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. SAME IMPLANTS WERE USED ON THE HEAD AND LINER EXCHANGED. NOTHING FURTHER TO REPORT. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12910114 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS WOUND BREAKDOWN WITH HEMATOMA AND DRAINAGE, RECURRENT INSTABILITY WITH DISLOCATION, AND COAGULOPATHY. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A REVISION 6 WEEKS PRIOR (CAPTURED IN (B)(4)) TO ADDRESS A FAILED CONSTRAINED LINER AND MEDICAL RECORDS INDICATED THE PATIENT WAS HAVING PAIN.. THE PATIENT DISLOCATED AFTER THAT SURGERY AND NEEDED A REDUCTION. DURING THIS CURRENT PROCEDURE THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE SURGEON REPORTED FINDING A COMPLETE FAILURE OF THE POSTERIOR SOFT TISSUE, AND REALLY NO LONGER ANY SOFT TISSUES PRESENT TO REPAIR. THERE WAS A SMALL AMOUNT OF HEMATOMA. HE WAS COAGULOPATHIC DURING THE CASE.

  Patient problems: Fluid Discharge; Hematoma; Joint Dislocation; Joint Laxity; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11871920 ↗
• InjuryApr 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  QUESTIONS: A. CAN YOU PLEASE CONFIRM IF THE PATIENT HAD A PREVIOUS REVISION DUE TO DISLOCATION THAT INVOLVES DEPUY PRODUCTS? IF YES, PLEASE PROVIDE THE PRODUCT DETAILS, OR IF IT WAS PREVIOUSLY REPORTED KINDLY PROVIDE A COMPLAINT NUMBER. B. PLEASE PROVIDE PATIENT INITIALS. ANSWERS FOR YOUR QUESTIONS: I CANNOT CONFIRM IF THE PATIENT HAD ANY OTHER PREVIOUS REVISIONS.

  Patient problems: Joint Dislocation

  MAUDE report 11677846 ↗
• InjuryJan 30, 2020Adverse 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) 1998; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9649351 ↗
• InjuryOct 23, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD HEAD AND LINER EXCHANGE DUE TO WEAR. UNKNOWN DATE OF SURGERY. ZIMMER LINER AND NEW SROM HEAD IMPLANTED. DOI: UNKNOWN; DOR; (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9225029 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN. PATIENT WAS REVISED TO ADDRESS SEPTIC ARTHRITIS AND COMPLICATED SUPERIOR BONE LOSS. OPERATIVE REPORTED THAT THERE WAS NO AREAS OF PURULENCE OR OBVIOUS INFECTION. DOI: (B)(6) 2017 - DOR: (B)(6) 2018 (RIGHT HIP) 5TH REVISION.

  Patient problems: Arthritis; Pain

  MAUDE report 8581948 ↗
• InjuryAug 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 7803092 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. COMPETITOR CUP IN PLACE WITH SROM STEM, REPLACED SROM HEAD. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7702175 ↗
• InjuryMar 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. HEAD AND LINER WERE REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7323123 ↗
• InjuryJun 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HOLD FOR JEWEL 11/14/17

  Patient problems: No Information

  MAUDE report 6676649 ↗