S-ROM 1365-16-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295033141), received between Apr 5, 2017 and Apr 22, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Degraded; Device Dislodged or Dislocated

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: METALLOSIS/DISLOCATION. RETRIEVAL ANALYSIS IDENTIFIED WEAR OF THE METAL LINER AND CORROSION AT THE TAPER JUNCTION OF THE HEAD/STEM. THERE IS NO INDICATION THAT THE STEM WAS REVISED.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 24957535 ↗
• InjuryFeb 7, 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 SIGNIFICANT PAIN IN THE LEFT HIP. METAL ION LEVELS WERE PERFORMED AND IT SHOWED SLIGHTLY ELEVATED METAL ION. DOI: (B)(6) 2004 DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP THIS PC IS BILATERAL LINKED WITH (B)(4) RIGHT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18659631 ↗
• InjuryMay 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED HER CONSTRAINED LINER MULTIPLE TIMES AGAIN. CUP, SCREW. LINER AND HEAD WERE REMOVED AND A ZB CUP AND DUAL MOBILITY WAS PLACED WITH A 28+12 SROM HEAD INSERTER INTO COMPETITOR DUAL MOBILITY POLY HEAD. CONSTRAINED LINER WAS STILL INTACT AND RING WAS STILL IN CORRECT LOCATION. DON'T HAVE RECORDS FOR THE CUP OR SCREW THAT WAS REMOVED. IT WAS A 50 PINNACLE CUP AND WHAT LOOKED TO BE A 35MM SCREW. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11762822 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO METAL-ON-METAL LEFT TOTAL HIP REPLACEMENT WITH ION PRODUCTION SECONDARY PAIN. OPERATIVE NOTES REPORTED THAT THE LINER AND HEAD WERE SLIGHTLY DISCOLORED. DOI: (B)(6) 2004. DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 11047963 ↗
• InjuryMar 12, 2020Corroded; Naturally Worn; Corroded; Naturally Worn

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT FAILED METAL-ON-METAL LEFT TOTAL HIP ARTHROPLASTY WITH METALLOSIS AND ABDUCTOR MUSCLE NECROSIS. PATIENT HAD ELEVATED METAL ION LEVELS AND MRI CONSISTENT WITH METAL-ON-METAL CORROSION AND PSEUDOTUMOR FORMATION. PATIENT FELT DISCOMFORT. UPON ENTERING INTO THE JOINT, THE FLUID WAS UNDER TENSION AND HAD EVIDENCE OF METAL DEBRIS. THERE WAS EVIDENCE OF BOTH ABDUCTOR MUSCLE NECROSIS AND CAPSULAR TISSUE NECROSIS INVOLVING MORE THAN 25% OF ABDUCTOR MUSCLES. THIS WAS CAREFULLY AND EXTENSIVELY DEBRIDED. HE HAD A SMALL AMOUNT OF SHUCK TOLERATED HIP EXTENSION AND EXTERNAL ROTATION TO ABOUT 70 DEGREES, BUT THE HIP DISLOCATED WHEN THE HIP WAS FLEXED TO 90 DEGREES WITH ONLY 20 DEGREES OF HIP INTERNAL ROTATION. THE TAPER AND BEARING SURFACE OF THE FEMORAL HEAD HAD MINIMAL EVIDENCE OF CORROSION. THE TAPER ON THE STEM WAS IN GOOD CONDITION WITH NO EVIDENCE OF CORROSION. NECROTIC TISSUE WAS REMOVED FROM AROUND THE RIM OF THE ACETABULUM. THERE WAS EVIDENCE OF CORROSION AT THE TAPER OF THE LINER ACETABULAR COMPONENT INTERFACE WITH PSEUDOMEMBRANE FORMATION ON THE UNDERSURFACE OF THE ACETABULAR LINER. TH

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Test Result

  MAUDE report 9823504 ↗
• InjuryFeb 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND RECURRENT DISLOCATIONS. THE PATIENT WAS REPORTED TO HAVE SLIPPED AND FELL ON (B)(6) 2007 RESULTING TO PAIN AND DISLOCATION. SEVERAL INCIDENTS OF DISLOCATIONS WERE REPORTED AND WERE TREATED WITH CLOSED REDUCTION. THERE WAS ALSO A NOTED BROKEN SCREW IN THE PREVIOUS REDUCTION; HOWEVER, IT IS UNKNOWN WHICH SPECIFIC SCREW BROKE. REVISION SURGERY WAS THEN OPTED ON (B)(6) 2008. REVISION NOTES REPORTED ABUNDANT SCAR AND THERE WAS SOFT TISSUE LAXITY AND VALGUS INSTABILITY. MOREOVER, DURING THE INITIAL HIP REPLACEMENT ON (B)(6) 2007, THE SROM STEM AND SLEEVE WERE TOO TIGHT IN THE BONE SO THE SROM STEM BACKED OUT AND FEMUR OVER REAMED TO 12MM. A CABLE WAS USED TO AVOID INSERTIONAL FRACTURE. IN THIS COURSE, IT RESULTED TO POSTERIOR AVULSION OF THE GREATER TROCHANTER. LATER ON (B)(6) 2007, AN I&D AND EVACUATION OF HEMATOMA WAS DONE AND THE AVULSION WAS REPAIRED. DOI: (B)(6) 2007; DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Adhesion(s); Joint Dislocation; No Code Available; Pain; Scar Tissue

  MAUDE report 9699613 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE RIGHT HIP. THERE WAS AN OPEN WOUND, SWELLING, PAIN AND PUS. OPERATIVE NOTE REPORTED PUS ENCOUNTERED, CUP WAS LOOSED, BONE STOCK EXTREMELY DEFICIENT AND PATIENT HAD A MULTIPLE ALLERGIES. SURGICAL PATHOLOGY REPORTED ACUTE INFLAMMATION AND NECROSIS CONSISTENT WITH ACUTE OSTEOMYELITIS OF THE IMPLANTS PORTIONS OF BONE ARE IRREGULARLY SHAPED AND MARKEDLY DISRUPTED WITH ATTACHED TAN-PINK TO RED BROWN SOFT TISSUES AND BLOOD CLOT. DOI: (B)(6) 2008. DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Inflammation; Injury; Necrosis; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 9107733 ↗
• InjuryApr 30, 2019Naturally Worn; Naturally Worn

  PFS ALLEGES ELEVATED METAL ION LEVELS.

  Patient problems: Foreign Body Reaction; No Code Available; Tissue Damage

  MAUDE report 8564572 ↗
• InjuryApr 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES CONSTRAINED LINER, LOOSENING OF CUP, ABDUCTOR MUSCLE REPAIR, DISLOCATION WITH CLOSE AND OPEN REDUCTION AND LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS CHRONICALLY UNSTABLE RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED BONY OSTEOPHYTES WERE REMOVED AS SOURCE OF IMPINGEMENT AND THE METAL LINER WAS REMOVED EASILY.

  Patient problems: Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 8554849 ↗
• InjuryJan 23, 2019Naturally Worn; Naturally Worn

  PPF HAS NO ALLEGATION.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8270117 ↗
• InjuryNov 9, 2018Material Disintegration; Material Disintegration

  LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2004, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER RIGHT SIDE. PATIENT HAS LARGE AMOUNTS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN HER BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER RIGHT THIGH AND GROIN. SHE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. DOI: (B)(6) 2004 ; DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8055836 ↗
• InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S ACETABULAR LINER AND HIP BALL WERE REPLACED DUE TO ELEVATED ION LEVELS. THE ACETABULAR CUP IS IN A MORE VERTICAL POSITION WHICH MAY BE CONSISTENT WITH THE ELEVATED ION LEVELS.

  Patient problems: No Code Available; Test Result

  MAUDE report 7909690 ↗
• InjuryAug 14, 2018Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  LITIGATION PAPERS ALLEGE: PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THE LEG, A POPPING AND CLICKING SOUND IN THE HIP; THE SENSATION THAT THE IMPLANT IS UNSTABLE AND WILL GIVE OUT; INABILITY TO WALK MODERATE OR LONG DISTANCES; INABILITY TO SLEEP ON PATIENT'S SIDE WITHOUT SEVERE PAIN; INABILITY TO SIT FOR MODERATE TO LONG PERIODS OF TIME; METALLOSIS; COBALT-CHROMIUM METAL TOXICITY; INFECTION; AND OTHER COMPLICATIONS. PPF ALLEGES LOOSENING OF CUP, METAL WEAR AND METALLOSIS. IT WAS ALSO INDICATED IN THE PPF THAT CUP, LINER, HEAD AND STEM WERE REVISED. DOI: (B)(6) 2005; DOR: (B)(6) 2005; (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Not Applicable; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 7780932 ↗
• InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE INFECTION. DOI: (B)(6) 2005; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Pain; Unspecified Infection

  MAUDE report 7690334 ↗
• InjuryJun 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT# (B)(4): PATIENT WAS REVISED TO ADDRESS SEVERE LIMITING THIGH PAIN. WHEN JOINT WAS EXPOSED, SEVERE METALLOSIS WAS FOUND. DOI: (B)(6) 2008; - DOR: (B)(6) 2010; (RIGHT HIP). UPDATE 1/10/2012 - LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 12/31/2012 - PFS AND MEDICAL RECORD RECEIVED. THE CORRECT DOI WAS PROVIDED, (B)(6) 2008. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW UPDATE AD 21 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE PPF AND MEDICAL RECORDS. PPF HAS NO NEW ALLEGATION THAT WILL CHANGE THE MDR REPORTABILITY. CORRECTED DOI AND IMPLANT MANUFACTURING DATES. DOI: (B)(6) 2008; DOR: (B)(6) 2010; RIGHT HIP.

  Patient problems: Tissue Damage

  MAUDE report 7606515 ↗
• InjuryApr 5, 2017Naturally Worn; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED DUE TO SUSPECTED METALLOSIS. NO METALLOSIS WAS OBSERVED. HIGH METAL IONS WERE FOUND IN THE BLOOD SERUM.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Metal Related Pathology; No Code Available; No Information; Pain

  MAUDE report 6461512 ↗