S-ROM 87-5956Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295218869), received between Dec 22, 2017 and Aug 26, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Device Dislodged or Dislocated

  It was reported that patient had dislocation. Tried to reduce in the ER and disassociated the head.DOI- (b)(6) 2001DOR- (b)(6) 2026Affected side- Left Hip

  Patient problems: Joint Dislocation

  MAUDE report 50454551 ↗
• InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR DISLOCATION - REOCCURRENCE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: 15/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 124603000. LOT ID: U55HM1000. COMPONENT TYPE: ACC. DESCRIPTION: APEX HOLE ELIM POSITIVE STOP. CATALOG ID: 124754000. LOT ID: UC8A41024. COMPONENT TYPE: SHELL. DESCRIPTION: DURALOC SHELL 100 SERIES 54MM. CATALOG ID: 521423. LOT ID: 642458. COMPONENT TYPE: SLEEVE. DESCRIPTION: SROM SLEEVE PROX ZTT 22B SM. CATALOG ID: 523422. LOT ID: 822029. COMPONENT TYPE: STEM. DESCRIPTION: SROM STEM STD 36MM +8L NECK 22MM X 17MM X165MM. CATALOG ID: 124954000. LOT ID: M6081K. COMPONENT TYPE: RING. DESCRIPTION: DURALOC DYNAMIC LOCK RING 54MM. CATALOG ID: 875956. LOT ID: 3770845. COMPONENT TYPE: HEAD. DESCRIPTION: SROM HEAD 32MM + 9MM. CATALOG ID: 124954000. LOT ID: M5355C. COMPONENT TYPE: RING. DESCRIPTION: DURALOC DYNAMIC LOCK RING 54MM. CATALOG ID: 124214527. LOT ID: M2068Y. COMPONENT TYPE: LINE

  Patient problems: Joint Dislocation

  MAUDE report 21405504 ↗
• InjuryJan 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CUP WAS REVISED DUE TO DISLOCATION AND THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 18454636 ↗
• InjuryNov 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY AFTER A FALL. AFTER THE FALL SHE BECAME UNSTABLE AND BEGAN TO DISLOCATE. THE PATIENT RECEIVED A +12 HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 15816153 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER REPLACED AND NEW HEAD IMPLANTED. INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 11060224 ↗
• InjuryDec 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION - INITIAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. TREATMENT: "RESUME PRECAUTIONS" DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2020, (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 10993485 ↗
• InjuryDec 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT UNDERWENT RIGHT HIP CLOSED REDUCTION ON (B)(6) AND (B)(6) 2017 DUE TO DISLOCATION. DOI: (B)(6) 2017, DOR: (B)(6) 2018, RIGHT HIP (THIRD REVISION).

  Patient problems: Joint Dislocation

  MAUDE report 10975900 ↗
• InjuryDec 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO HIP DISLOCATION. LINER REPLACED AND NEW HEAD IMPLANTED. CONSTRAINED LINER WAS LOOSE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 10957876 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AFTER THE FIRST REVISION. DOI: (B)(6) 2016. DOR: NONE. REPORTED (LEFT HIP, SECOND EVENT).

  Patient problems: Burning Sensation; Edema; Hypoesthesia; Pain; Test Result

  MAUDE report 9495267 ↗
• InjuryAug 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE PATIENT HAD AN SROM STEM AND STRYKER CUP IMPLANTED APPROXIMATELY 15 YEARS AGO BY THE SURGEON. THE PATIENT HAD A RECENTLY BEGAN TO HAVE DISLOCATION ISSUES WITH THEIR HIP SO THE SURGEON REVISED THE CONSTRUCT TO MAKE IT MAKE IT MORE STABLE. THE SROM STEM AND SLEEVE WERE LEFT IMPLANTED AND THE HIP BALL WAS EXPLANTED AND REPLACED WITH A NEW HIP BALL. DOI: UNKNOWN. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8871253 ↗
• InjuryOct 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8005025 ↗
• InjuryApr 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7450287 ↗
• InjuryFeb 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7243741 ↗
• InjuryFeb 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 7240587 ↗
• InjuryJan 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THE PATIENT HAD DISLOCATED 4-5 TIMES. REMOVED SMITH NEPHEW CUP AND LINER. IMPLANTED PINNACLE CUP WITH 36 ID AND NEW 36 +12 11/13 TAPER HEAD. DOI: (B)(6) 2011; (B)(6) 2017; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7211955 ↗
• InjuryJan 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. (B)(6) 2017; (B)(6) 2017 LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7169382 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT ALSO STATES THAT THE PATIENT UNDERWENT I&D. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7141791 ↗