S-ROM 52-3192Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295170860), received between Jul 26, 2017 and Feb 18, 2025 — classified as 51 injuries.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A PAINFUL LEFT HIP. THERE WAS A LOOSENING REPORTED AT THE STEM AND SLEEVE AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21403448 ↗
• InjuryApr 17, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO DISLOCATION OF TOTAL HIP ARTHROPLASTY. SURGEON PULLED THE STEM, HEAD, AND LINER, THEN CHANGED THE VERSION IN THE FEMORAL STEM. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19127665 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS HAVING A REVISION SURGERY FOR SUSPECTED PSEUDOTUMOR RELATED TO METAL ON METAL IMPLANTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: PSEUDO TUMOUR. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: REVISION SURGERY REQUIRED. IS THE PATIENT PART OF A CLINICAL STUDY?: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18004757 ↗
• InjuryMar 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE STEM BROKE ABOVE SLEEVE. COMPLETE SHEERED BREAK OF STEM. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16642594 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE INSTABILITY AND IMPLANT WEAR. DOI: (B)(6) 2003. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16495430 ↗
• InjuryApr 7, 2022Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO METAL ON METAL WITH ULTIMA IMPLANTS. THERE WAS METALOSIS PRESENT AND CORROSION ON NECK TAPER. SURGEON WAS SUCCESSFUL REMOVING THE SROM STEM RATHER EASILY AND HAD TO WORK A BIT TO TAKE OUT SLEEVE. REPLACED SROM WITH ARCOS FROM ZIMMER. REPLACED METAL LINER WITH PINNACLE DUAL MOBILITY METAL LINER. THERE WAS LOOSENING AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2007; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 14041823 ↗
• InjuryJan 6, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AND SLEEVE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13175606 ↗
• InjuryMay 19, 2021Degraded; Degraded

  ASR REVISION LITIGATION RECORDS RECEIVED. RECORDS ALLEGES PAIN, INJURY, ECONOMIC LOSS, WALKING DIFFICULTY AND EXCESSIVE COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2008, DOR: (B)(6) 2019, RIGHT HIP. MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METALLOSIS. OPERATIVE NOTES INDICATED IN MRI SHOWS SOME DIFFUSE SYNOVITIS. UPON OPENING THE CAPSULE THERE WAS SOME FLUID PRESSURE THAT APPEARS MORE MILKY. THERE WAS A LOT OF STAINING OF THE TRUNNION AND A LITTLE BIT PITTING.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11847973 ↗
• InjuryApr 27, 2021Degraded; Degraded

  PINNACLE UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO MALFUNCTION OF MOM LEFT HIP ARTHROPLASTY RESULTING TO PAIN, ELEVATED COBALT AND CHROMIUM LEVEL AND MECHANICAL SENSATION LEFT THA. OPERATIVE NOTE REPORTED MILKY YELLOW FLUID COLLECTION CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION WITH DARK STAINING OF THE CAPSULAR TISSUES AND SYNOVIUM. NOTICEABLE GROSS WEAR OF THE SUPERIOR ASPECT OF THE ACETABULAR LINER. SIGNIFICANT CORROSION NOTED AT THE LOCKING MECHANISM OF THE LINER AND THE SHELL. HOWEVER, MINIMAL CORROSION NOTED AT THE HEAD NECK TAPER JUNCTION. DOI: (B)(6) 2008; DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 11731550 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON INFORMED THE SALES CONSULTANT THAT HE HAD PERFORMED THIS PATIENT'S INITIAL SURGERY ABOUT 10-11 YEARS PRIOR, EXACT DATE UNKNOWN. HE WAS UNABLE TO PULL UP THE OPERATIVE NOTE TO GIVE ME AN EXACT DATE. THIS PATIENT SUFFERED A HIP DISLOCATION THAT WAS BELIEVED TO HAVE HAPPENED SEVERAL MONTHS PRIOR. THIS PATIENT SUFFERS FROM CEREBRAL PALSY AND IS A BED BOUND PATIENT. THIS PATIENT ALSO UNFORTUNATELY HAD AN ULCER ON THEIR HIP THAT WENT DOWN INTO THE JOINT SPACE. DR. DECIDED THIS PATIENT'S BEST OPTION WAS UNFORTUNATELY TO REMOVE THE IMPLANTS AND PERFORM A GIRDLESTONE PROCEDURE. ONCE IMPLANTS WERE PROPERLY REMOVED A THOROUGH DEBRIDEMENT WAS PERFORMED OF THEIR HIP AND THE CLOSING PROCESS BEGAN. DOI: 10 TO 11 YEARS PRIOR, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11686664 ↗
• InjuryMar 17, 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, PATIENT WAS REVISED TO ADDRESS LEFT HIP MODULAR METAL-ON-METAL TOTAL HIP ARTHROPLASTY WITH ADVERSE LOCAL TISSUE REACTION AND POSSIBLE METAL TOXICITY. PATIENT HAS DEVELOPED LEFT HIP PAIN AND MILD ABDUCTOR IRRITATION BUT NO SEVERE WEAKNESS. 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 ONLY A VERY SCANT AMOUNT OF CLEAR, BENIGN-APPEARING STRAW-COLORED JOINT FLUID. THERE WERE A FEW, PATCHY AREAS OF DARK GRAY TO BLACK STAINED SYNOVIUM BUT THE MAJORITY OF THE PERIPROSTHETIC SYNOVIAL SOFT TISSUES WERE NOTED TO BE GROSSLY HEALTHY APPEARING WITHOUT GRANULATION, FRIABILITY, OR NECROSIS. THERE WAS NO GROSS EVIDENCE OF INFECTION. DOI: (B)(6) 2010, DOR: (B)(6) 2019 (LEFT HIP). PATIENT WAS BILATERAL. SEE (B)(4) FOR THE RIGHT HIP.

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

  MAUDE report 9843421 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS, INSTABILITY IN HIP. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9835655 ↗
• InjuryMar 16, 2020Corroded; Degraded; Corroded; Degraded

  LITIGATION ALLEGES PAIN AND INJURY. DOI: (B)(6) 2007; DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Edema; Injury; Osteolysis; Pain

  MAUDE report 9834969 ↗
• InjuryFeb 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 PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METAL ON METAL TISSUE REACTION, METALLOSIS, SUSPECTED PSEUDOTUMOR AND RESULTANT INSTABILITY. OPERATIVE NOTES INDICATED EXTENSIVE METAL ON METAL WEAR DEBRIS EXTENDING THROUGH CHRONIC DISRUPTION OF THE ANTERIOR SUPERIOR ASPECT OF GLUTEUS MEDIUS ON THE GREATER TROCHANTER WITH SOFTENING OF THE BONE AND EXTENSIVE METAL DEBRIS. HAVING SPONTANEOUS DISLOCATIONS OF THE HIP LAST SEVERAL MONTHS, PERSISTENT LIMP SINCE THEN. NO EVIDENCE OF INFECTION BUT SIGNIFICANTLY ELEVATED COBALT AND CHROMIUM LEVEL. ANTERIOR PSEUDOCAPSULE WAS EXCISED INDICATING NO EVIDENCE OF INFLAMMATION AND NO EVIDENCE OF INFECTION. CUP WAS A BIT ON THE VERTICAL AND ENTEVERTED SIDE. ONE SCREW IN THE ACETABULAR SHELL ITSELF WAS BACKED OUT AND THE CUP IS WELL FIXED. DOI: (B)(6) 2010, DOR: (B)(6) 2018 RIGHT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Test Result

  MAUDE report 9740963 ↗
• InjuryFeb 17, 2020Corroded; Degraded; Corroded; Degraded

  DOI: 2002 - DOR: 2006. PATIENT IS A RESIDENT OF (B)(6). UPDATE (B)(6) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE DOI AND DOR HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE (B)(6) 2019 (B)(4) HAS BEEN RE-OPENED DUE TO RECEIPT OF PCF AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INTACT ACETABULAR SHELL AND FEMORAL COMPONENT WITH MARKED SYNOVITIS RIGHT HIP, SOFT TISSUE DEGRADATION. XRAYS SHOWED EVIDENCE OF SOME PROGRESSIVE OSTEOLYSIS IN THE MEDIAL WALL OF THE ACETABULUM, PROBABLE OF MICROSCOPIC LOOSENING OF THE FEMORAL COMPONENT AS PER SYMPTOMS, TENSE SYNOVIAL EFFUSION WAS ENCOUNTERED. OPERATIVE NOTES INDICATED UPON OPENING THE EXTENSOR MECHANISM, THE CAPSULE ITSELF APPEARED TO BE TENSE, A LARGE AMOUNT OF FLUID WHICH APPEARED TO BE UNDER PRESSURE, SOME FIBROUS AND SOFT TISSUE TYPE DEBRIS SCATTERED THROUGHOUT IT. THERE WAS QUITE A BIT CORROSION AROUND THE TAPER OF THE FEMORAL COMPONENT AND THERE WHERE SMALL AMOUNTS OF PLASTIC LIKE LINING THAT COULD BE RELATED TO FIBROUS TYPE DEBRIS. ADDED ACCOUNT NAME, LAW FIRM, LAWYER, SURGEON, MEDICAL HISTORY, DATE OF IMPLANT, STEM AND PRODUCT DETAILS

  Patient problems: Adhesion(s); Edema; No Code Available; Osteolysis

  MAUDE report 9717518 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. THERE IS NO ALLEGATION. IT WAS INDICATED THAT PATIENT HAD A SECOND REVISION ON (B)(6) 2014. THE CUP, HEAD AND LINER WERE REMOVED. (B)(6) AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN. REVISION NOTES STATED THAT THERE WAS GOING TO FRACTURED OFF WHEN REMOVING THE STEM ITSELF. THE PART OF TROCHANTER WAS THIN AT THIS POINT ANTERIORLY THAT THERE WAS JUST ALMOST NO CONNECTION BETWEEN THE DIAPHYSIS AND THE TROCHANTER ITSELF.

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 9490571 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION REPORTED. PRIMARY SURGERY NOTES PROVIDED INDICATE THAT DURING PRIMARY SURGERY, THE PATIENT HAD A 1500 CC ESTIMATED BLOOD LOSS AND WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS. DOI: (B)(6) 2007; DOR: NO REVISION REPORTED (RIGHT HIP).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9437667 ↗
• InjuryNov 20, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS UNSTABLE AND SO THE SURGEON WENT BACK IN FOR A REVISION SURGERY OF HER PRIMARY SROM HIP. UPON ENTERING THE JOINT CAPSULE, IT WAS DISCOVERED THERE WAS METALOSIS. THE METAL LINER, SROM HEAD, AND STEM WERE REMOVED AND ALL THREE WERE REPLACED. THE METAL WEAR SEEMED TO HAVE COME FROM THE HEAD/NECK JUNCTION AND NOT THE HEAD/LINER INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9348798 ↗
• InjuryOct 2, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS WITH PSEUDOTUMOR FORMATION WITH DESTRUCTION AND LOOSENING OF THE COMPONENTS. REVISION NOTES STATED THAT SOME BURSITIS WITH FLUID WAS FOUND. THE PROXIMAL METAPHYSIS WAS COMPLETELY CIRCUMFERENTIALLY LOOSE . THE LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED BONE LOSS AND PHYSICAL LIMITATIONS, EXPERIENCED A FOOT DROP, EXTENSIVE METALLOSIS AND BONE DESTRUCTION, PSEUDOTUMOR FORMATION WITH BONE DESTRUCTION, AND METAL DEBRIS.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Inflammation; Loss of Range of Motion; Metal Related Pathology; No Code Available; Osteolysis; Pain; Swelling/ Edema; Test Result; Unspecified Tissue Injury

  MAUDE report 9144651 ↗
• InjurySep 24, 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 DISLOCATION, CLICKING, DISCOMFORT, BILATERAL LOWER EXTREMITY FOOT DROP, PAIN, ELEVATED BLOOD METAL IONS AND METAL ON METAL REACTION. PATIENT HAD STATED THAT SHE FELT THAT HER HIP HAS SUBLUXED AT TIMES. RANGE OF MOTION WAS NOTED TO BE LIMITED. THERE WAS TENDERNESS AND WEAKNESS AS WELL. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS WITH "DISH SOAP WATER FLUID", A SIGNIFICANTLY ABDUCTED ACETABULAR COMPONENT AND GROSS TRUNNIONOSIS ON THE FEMORAL HEAD. DURING THE REVISION SURGERY, PATIENT HAD ACUTE BLOOD LOSS ANEMIA SECONDARY TO THE SURGERY. TWO PACKED RED BLOOD CELLS WERE GIVEN. DOI: (B)(6) 2008. DOR: (B)(6) 2017. (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage; Weakness

  MAUDE report 9110263 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8976392 ↗
• InjuryAug 12, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  REVISION FOR SROM STEM LOOSE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8885324 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION; ASR XL; LEFT HIP. REASON FOR REVISION: PAIN. SURGEON CONFIRMATION FORM ALSO INDICATED, MARS, MRI SHOWS FOCAL OSTEOLYTIC LESIONS ARE SEEN AT THE BONE PROSTHESIS INTERFACE OF THE PROXIMAL FEMUR. COBALT AND CHROMIUM LEVELS ARE GOING UP. DOI: (B)(6) 2008; DOR:(B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 8871030 ↗
• InjuryJun 4, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT. DOI: (B)(6) 2009, DOR: (B)(6) 2010, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8666230 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. PFS ALLEGE PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8616836 ↗