S-ROM 52-3292Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295170976), received between Dec 20, 2018 and May 9, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Biocompatibility” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD SEVERE HIP DYSPLASIA AND HAD BOTH OF HER HIPS REPLACED BY SURGEON. BECAUSE OF HER HIP DYSPLASIA THE PATIENT OVER THE LAST 2 YEARS BECAME LAX AND HAD A LEG LENGTH DESCREPENCY. SURGEON REVISED HER SHORT SIDE AND EXPLANTED A 16X11 30STD NECK SROM AND IMPLANTED A 16X11 36+6 SROM STEM WHICH PROVIDED THE PATIENT WITH ADDITIONAL LEG LENGTH AND OFFSET. THE SROM SLEEVE, ACETABULAR CUP AND LINER WERE LEFT IN SITU. NO ADVERSE EVENTS AS THE RESULT OF OUR PRODUCTS. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 21997586 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FRACTURED AT DISTAL END OF STEM. REVISED WITH LONG SROM STEM AND NEW HEAD. SLEEVE WAS WELL FIXED AND STAYED. CUP/LINER WAS COMPETITIVE PRODUCT AND LEFT IN TACT. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Limb Fracture

  MAUDE report 12696478 ↗
• InjuryFeb 16, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT ORIGINAL IMPLANT DATE UNKNOWN. THIS PATIENT HAD HER LEFT HIP REPLACED BY A SURGEON APPROXIMATELY 12 YEARS AGO. THE PATIENT WAS DOING WELL UNTIL RECENTLY WHERE SHE WAS EXPERIENCING SOME PAIN AND DISCOMFORT IN HER HIP. SHE WENT TO OFFICE TO SEE DR. (B)(6), XRAYS LOOK UNREMARKABLE BUT HER LABS INDICATED SHE HAD ELEVATED COCR LEVELS. DR. (B)(6) SCHEDULED THE PATIENT FOR A THR AS HE SUSPECTED THAT TRUNION AND METAL HIP BALL WERE PRODUCING METAL DEBRIS. DURING THE SURGERY THE NEUTRAL PINNACLE LINER, METAL FEMORAL HIP BALL, AND THE 16X11 30 STD NECK SROM STEM WERE EXPLANTED. THE SROM SLEEVE AND PINNACLE ACETABULAR CUP WERE LEFT IN SITU. THE SROM STEM HAD DAMAGE OR TRUNIONOSIS ON THE NECK AS WELL AS THE INNER TAPER OF THE METAL FEMORAL HIP BALL. A NEW SROM STEM, PINNACLE LINER, AND CERAMIC FEMORAL HIP BAL WERE IMPLANTED. I DO NOT HAVE THE LOTT # INFORMATION FOR THE IMPLANTS LEFT IN SITU. I DO NOT HAVE THE LOT # FOR THE 32MM METAL HIP BALL THAT WAS EXPLANTED. DOI: 12 YEARS AGO, DOR: (B)(6) 2021, LEFT HIP.

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

  MAUDE report 11332178 ↗
• InjurySep 9, 2020Corroded; Degraded; Corroded; Degraded

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, DISCOMFORT AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED MILD METALLOSIS WITH TAN STAINING OF THE RIGHT HIP JOINT TISSUES. FIBRINOUS EXUDATIVE TISSUE AT THE BASE OF THE GREATER TROCHANTER AND CALCAR WITH MILD TRUNNIONOSIS WITH BLACK STAINING AT THE MORSE TAPER JUNCTION OF THE ASR HEAD AND STEM. CLINIC VISITS REPORTED OF CRUNCHING, POPPING AND GRINDING. DOI: (B)(6) 2007 - DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; No Code Available; Pain

  MAUDE report 10508848 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS RIGHT HIP NODULAR METAL-ON-METAL TOTAL HIP ARTHROPLASTY WITH ADVERSE LOCAL TISSUE REACTION AND POSSIBLE METAL TOXICITY AND RIGHT HIP GLUTEUS MEDIUS INSERTIONAL TENDON TEAR. PATIENT HAS DEVELOPED RIGHT HIP PAIN, ABDUCTOR WEAKNESS, AND ASSOCIATED LIMP. PHYSICAL EXAM AND IMAGING STUDIES HAVE RAISED SUSPICION FOR PROBABLE ABDUCTOR INSERTIONAL TENDON TEAR. LABORATORY STUDIES SHOWED THAT PATIENT HAD ELEVATED SERUM METAL ION LEVELS WITH COBALT GREATER THAN 8 AND CHROMIUM GREATER THAN 4. OPERATIVE NOTES STATED THAT UPON ENTRY INTO THE JOINT, THERE WAS EXPRESSION OF A SCANT AMOUNT OF THICK STRAW-COLORED FLUID WITH MULTIPLE DEBRIS PARTICLES. THE FLUID WAS SENT FOR HISTOPATHOLOGIC ANALYSIS WHICH DEMONSTRATED ABSENCE OF NEUTROPHILS BUT A SIGNIFICANT AMOUNT OF A CELLULAR DEBRIS. PERIPROSTHETIC SOFT TISSUES WERE NOTED TO BE GROSSLY NORMAL-APPEARING AND THAT THERE WERE NO OBVIOUS SIGNS OF INFECTION OR NECROSIS. A REPRESENTATIVE SAMPLE OF SYNOVIUM WAS SENT FOR HISTOPATHOLOGIC ANALYSIS WHICH AGAIN DEMONSTRATED A SIGNIFICANT SCARCITY/RELATIVE ABSENCE OF NEUTROPHILS. THESE FINDINGS, COMBINED WITH PREOPERATIVE NEGATIVE SEROLOGIC INDICES EFFECTIVELY RULE OUT PERIPROSTHETI

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

  MAUDE report 9843362 ↗
• InjuryApr 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM. (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8503879 ↗
• InjuryFeb 28, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2005, DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Inflammation; Limited Mobility Of The Implanted Joint; Pain; Swelling; Tissue Damage; Unspecified Infection

  MAUDE report 8377307 ↗
• InjuryFeb 27, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 8375421 ↗
• InjuryFeb 6, 2019Biocompatibility; Biocompatibility

  IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Injury; No Code Available; Pain; Tissue Damage

  MAUDE report 8310072 ↗
• InjuryFeb 4, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METALLOSIS, METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Discomfort; Pain; Test Result; Tissue Damage

  MAUDE report 8301776 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT HAS SIGNIFICANT DISCOMFORT, PAIN, STIFFNESS, LOSS OF MOTION, AND, UPON INFORMATION AND BELIEF, LOOSENING AND/OR DISLOCATION OF THE HIP, ALL OF WHICH RESULTS IN DIFFICULT AND PAINFUL MOBILITY AND AMBULATION, ALL OF WHICH IS ONGOING, AND HAS OR IS AT RISK FOR METAL TOXICITY FROM THIS IMPLANT, AND NEEDS ONGOING CARE AND TREATMENT. IT IS FURTHER ALLEGED THE PATIENT WILL HAVE TO UNDERGO REVISION SURGERY. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2011 - DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Discomfort; Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 8184129 ↗