S-ROM MARATHON 1220-72-332Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295015918), received between Feb 12, 2018 and Jan 5, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR POLY WEAR. THERE WAS NO FURTHER INFO AVAILABLE. DOI: (B)(6) 1999, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23961041 ↗
• InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INSTABILITY AND RECURRENT DISLOCATIONS. AT REMOVAL THE FEMROAL HEAD SHOWED CORROSION. AT REMOVAL THE ACETABULAR LINER SHOWED NECK IMPINGEMENT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21979142 ↗
• InjuryFeb 13, 2024Naturally Worn; Naturally Worn

  REVISION DUE TO WEAR OF POLY ACETABULAR LINER. IT WAS REPORTED THE FEMORAL HEAD WAS ALSO REPORTED. THERE ARE CURRENTLY NO ALLEGED DEVICE DEFICIENCIES WITH THE REMOVED FEMORAL HEAD. IMPLANT WAS REMOVED TO ADDRESS THE WEAR OF THE ACETABULAR LINER.

  Patient problems: Insufficient Information

  MAUDE report 18695261 ↗
• InjurySep 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC IS TO CAPTURE THE MEDICAL RECORD FROM (B)(6) 2021 NOTE THAT THE PATIENT HAS DISLOCATED 3 TIMES AND HAS INSTABILITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 12525392 ↗
• InjurySep 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) /2017, THE PATIENT HAD LEFT PAIN AND CLICKING, AN MR OF THE LEFT HIP WAS REPORTED TO SHOW A SMALL HIP EFFUSION, SYNOVIAL THICKENING WITHIN THE ILIOPSOAS BURSA, ALONG WITH RIGHT TROCHANTERIC BURSITIS. (NO MENTION OF ANY INVASIVE PROCEDURE) ON (B)(6) 2017, THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS POLYETHYLENE WEAR. A PREOPERATIVE RADIOGRAPH WAS REPORTED TO SHOW SOME POLYETHYLENE WEAR. ON (B)(6) 2018 THE PATIENT HAS A MEDICAL DIAGNOSIS OF THA REVISION, AND DISLOCATION (NO MENTION OF WHEN THAT DISLOCATION HAD HAPPENED).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Joint Dislocation; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 12487760 ↗
• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION AND MEDICAL RECORDS RECEIVED INDICATED THAT ON 12/29/2020, THE PATIENT HAD A REVISION LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS FAILED LEFT HIP. THE POLY LINER WAS NOTED TO HAVE BEEN COMPLETELY WORN THROUGH. THE PATIENT WAS NOTED TO HAVE INCREASING DISCOMFORT, PAIN, DECREASED RANGE OF MOTION, AND PREOPERATIVE RADIOGRAPHS REPORTEDLY SHOWED EVIDENCE OF MIGRATION. DEPUY COMPONENTS WERE NOTED TO HAVE BEEN USED DURING THIS PROCEDURE. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE POLY LINER HAD BEEN COMPLETELY WORN THROUGH. THERE WAS SLIGHT DAMAGE TO THE METAL SHELL, BUT IT WAS RETAINED. THERE BLACK TISSUE DUE TO TITANIUM DEBRIS. THE FEMORAL STEM WAS WELL FIXED AND RETAINED. THE TROCHANTERIC CLAMP WAS REMOVED. BONE LOSS AND OSTEOLYSIS WERE ALSO NOTED. MEDICAL RECORDS FROM (B)(6) 2021 NOTE THAT THE PATIENT IS 6 MONTHS POST REVISION, DISLOCATED HIP AND HAD TO HAVE IT REDUCED. MEDICAL RECORD FROM (B)(6) 2021 NOTE THAT THE PATIENT HAS DISLOCATED 3 TIMES AND HAS INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 12341913 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA PERFORMED OVER 20 YEARS AGO WITH NO INFORMATION AVAILABLE ABOUT THAT SURGERY. ON (B)(6) 2020. THE PATIENT HAD A RIGHT THA REVISION OF THE HEAD AND LINER FOR POLY WEAR REPORTED IN (B)(4). THE PATIENT RECEIVED A REREVISION TO TREAT PAIN SECONDARY TO TOO MUCH OFFSET AND LEG LENGTH. THIS NEW SURGEON WANTED TO REMOVED THE ENTIRE SROM CUP AND PUT IN A COMPETITOR DUAL MOBILITY AND NEEDED TO USE MY SROM 11/13 TAPER HEADS. THE SURGEON REMOVED THE METAL HEAD, POLY DIAL LINER AND LOCKING PINS, SCREW AND CUP. HE IMPLANTED A COMPETITOR DUAL MOBILITY HEAD AND USED MY 28MM +3 METAL SROM HEAD. HE WAS HAPPY WITH THE LEG LENGTHS AND OFFSET. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10752620 ↗
• InjuryOct 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED FOR INSTABILITY UNRELATED TO COMPONENT POSITION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10639431 ↗
• InjurySep 8, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR POORLY POSITIONED ACETABULAR COMPONENT : ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. MEDICAL RECORDS RECEIVED ON 31 JUL 2020 AND 3 AUG 2020 WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. ON (B)(6) 2003, THE PATIENT UNDERWENT A A RIGHT HIP REVISION INVOLVING THE REMOVAL OF AN UNKNOWN HIP DUE TO PAIN, POLY WEAR, AND OSTEOLYSIS. A DEPUY S-ROM 60 MM DEEP PROFILE +6 ZTT CUP, WITH TWO DOME SCREWS AND ONE RIM SCREW, ALONG WITH ONE RIM PIN, AND A 32 MM INNER DIAMETER 10 DEGREE POSTERIOR-LIPPED +3 LATERALIZED DEPUY LINER WERE IMPLANTED. ON THE FEMORAL SIDE, HOWMEDICA PRODUCT WAS IMPLANTED. ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO A WORN, FRACTURED, AND DISLOCATED LINER. THE PATIENT WAS ALSO EXPERIENCING GRINDING AND INSTABILITY. THE SURGEON NOTED SLIGHT WEAR ON THE DEPUY CUP AND MINIMAL LYSIS. THE CUP WAS WELL INGROWN AND NOT REVISED. AN S-ROM LIPPED LINER WAS IMPLANTED WITH ONE LOCKING SCREW AND ONE LOCKING PIN. THE SURGEON INDICATED THE CUP HAD MINIMAL ANTEVERSION, BUT FELT THE CUP GAVE THE PATIENT GOOD ST

  Patient problems: Joint Dislocation; No Code Available; Osteolysis

  MAUDE report 10501533 ↗
• InjuryJul 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10334178 ↗
• 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 FEMORAL HEAD (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 9151740 ↗
• InjurySep 17, 2019Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  SUBJECT ID: (B)(6). DOTS. CLINICAL NOTIFICATION RECEIVED FOR LEFT HIP REVISION TO ADDRESS DISLOCATION AND POLYETHYLENE LINER WEAR DATE OF IMPLANTATION: UNKNOWN. DATE OF REVISION #1: (B)(6) 2013. DATE OF REVISION #2: (B)(6) 2019. (LEFT HIP). PRODUCTS PRESENT AT THE TIME OF THE REVISION: CATALOG: 97722190. LOT: 160051. DESCRIPTION: RECLAIM DISTAL TAPERED 22X190A. CATALOG: 122072332. LOT: 3521578. DESCRIPTION: PINNACLE MARATHON LINER +3 LAT 10 DEGREE 32MM. CATALOG: 521552. LOT: 302728. DESCRIPTION: SROM SCREW 5.0MM DIA 25 MM LG. CATALOG: 521552. LOT: 280761. DESCRIPTION: SROM SCREW 5.0MM DIA 25 MM LG. CATALOG: 550295. LOT: 274941. DESCRIPTION: SROM PIN LOCK 5.0MM DIA. CATALOG: 197520095. LOT: 214070. DESCRIPTION: RECLAIM PROXIMAL BODY CONE 20 X 95MM. CATALOG: 136524000. LOT: D13030120. DESCRIPTION: ARTICUL/EZE HEAD COCR 32MM +13.

  Patient problems: Adhesion(s); Edema; Joint Dislocation; Joint Disorder; No Code Available

  MAUDE report 9077854 ↗
• InjuryAug 20, 2018Naturally Worn; Naturally Worn

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES DISCOMFORT, ASYMMETRIC WEAR AND INSTABILITY. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY PATIENT WAS REVISED DUE TO FAILED ACETABULAR COMPONENT. REVISION NOTES REPORTED OF LARGE AMOUNT OF SCAR TISSUE, OSTEOLYSIS, 2 PERIPHERAL SCREWS WERE REMOVED, AND FOUND THE CUP TO BE LOOSE. CLINICAL VISITS REPORTED OF LOOSE ACETABULAR CUP, AND OSTEOLYTIC DEFECT. DOI: (B)(6) 2004; DOR: (B)(6) 2005; (LEFT HIP).

  Patient problems: Discomfort; Necrosis; Not Applicable; Osteolysis; Scar Tissue

  MAUDE report 7796961 ↗
• InjuryJul 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO INDICATED THAT THE PATIENT HAD A DEPUY SROM PRIMARY STEM AND ZTT2 SHELL IMPLANTED. THE SURGEON REMOVE THE SHELL, LINER AND HEAD. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7719164 ↗
• InjuryFeb 12, 2018Naturally Worn; Naturally Worn

  DER STATES SROM LINER EXCHANGED FOR WEAR. DOI: (B)(6) 2002; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7262922 ↗