S-ROM 1365-43-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295033776), received between Dec 2, 2017 and Jun 28, 2024 — classified as 1 death, 29 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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. 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Degraded; Degraded

  PATIENT HAD A FAILED ACETABULAR COMPONENT ON METAL-ON-METAL TOTAL HIP WITH EVIDENCE OF TRUNNION CORROSION AND NO EVIDENCE OF INFECTION. DURING THE OPERATION, THERE WAS NO EVIDENCE OF PUS AND METALLOSIS BUT THERE WAS SOME MILD STAINING METALLIC LOOKING IN THE INFERIOR ASPECT OF THE ACETABULUM. THERE WAS SOME MILD STAINING BEHIND THE LINER BUT VERY MINIMAL. THE STEM WAS GROSSLY LOOSE, HAD ROTATED INTO RETROVERSION AND WAS GROWN OVER WITH BONE. THE HEAD HAD SOME CORROSION OF THE TAPER. THE SLEEVE WAS THEN CUT USING SHARP DISSECTION BECAUSE IT WAS SCARRED DOWN. DOI: (B)(6) 2009. DOR: (B)(6) 2014 LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 19632343 ↗
• MalfunctionMay 15, 2024Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT NEW SROM STEM AND SROM METAL HEAD WERE IMPLANTED, AS THE PATIENT HAD LYSIS/PAIN, WHEN IMPLANTING THE NEW HEAD ON THE NEW STEM TRUNION, THE HEAD DID NOT ENGAGE THE TAPER AFTER 2 ATTEMPTS, A NEW HEAD WAS OPENED AND UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319823 ↗
• InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2009 DATE OF EVENT: (B)(6) 2024 (LEFT HIP) TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 19298037 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO METALLOSIS RESULTING IN PSEUDOTUMOR. DATE OF IMPLANT: (B)(6) 2009 DATE OF REVISION: (B)(6) 2023 (RIGHT HIP). TREATMENT: HEAD AND LINER WERE REVISED.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 17740807 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED, DUE TO THE FOLLOWING PATHOLOGIC FINDINGS: ALTR, CYST, JOINT EFFUSION, OSTEOLYSIS, CORROSION, FLUID COLLECTION, METALLOSIS, PSEUDOTUMOR, SYNOVITIS. DOI: (B)(6) 2010, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16553005 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINALLY DATE IS UNKNOWN OF THIS PATIENT'S SURGERY PERFORMED BY SURGEON. PATIENT HAD AN SROM, MODULAR METAL ON METAL CONSTRUCT PLACED SOMETIME PREVIOUSLY. THIS HAS SINCE GO ON TO INCREASED METAL ION LEVELS. THE METAL LINER AND METAL HEAD WERE REMOVED AND IT WAS REVISED TO A CERAMIC ON POLY CONSTRUCT. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Metal Related Pathology

  MAUDE report 15014072 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP DONE ON AN UNKNOWN DATE OF 2008. SURGEON WAS UNSURE OF THE EXACT DATE. PATIENT WAS IMPLANTED WITH A METAL ON METAL CONSTRUCT. PATIENT WAS SHOWING SIGNS OF METALLOSIS WHICH WAS CONFIRMED DURING THE PROCEDURE. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A REVISION OF THE HEAD AND LINER. THE METAL LINER WAS REMOVED AND A PLASTIC POLY WAS INSERTED. A TRIAL REDUCTION WAS PERFORMED WITH A 36 +3 HEAD AND FOUND TO BE SLIGHTLY SHORT. SURGEON ASKED FOR A 36 +6 HEAD AND THE REAL HEAD WAS OPENED AND IMPLANTED. UNABLE TO RETRIEVE THE LOT NUMBERS OF THE EXPLANTS. PATIENTS HIP WAS REDUCED AND FOUND TO BE STABLE. CLOSING PROCESS BEGAN. DOI: 2008, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 14945415 ↗
• InjuryJun 29, 2022Naturally Worn; Naturally Worn

  PINNACLE LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT WAS REVISED WAS DUE TO HIGH HEAVY METAL POISONING. RECORDS ALSO ALLEGES PAIN, INJURY, TOXIC HEAVY COBALT AND CHROMIUM DEBRIS, METALLOSIS, METAL WEAR, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2012. DOR: (B)(6) 2021. UNK HIP.

  Patient problems: Discomfort; Distress; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14855691 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS OPERATIVE NOTES WERE REVIEWED AND INDICATED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT A RIGHT PRIMARY HIP ARTHROPLASTY UTILIZING DEPUY SYNTHES COMPONENTS WITH NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT HIP REVISION FOR ADVERSE REACTION TO METAL ON METAL DEBRIS. THE HOLE ELIMINATOR, LINER AND HEAD WERE REVISED. A LARGE EFFUSION ("BROWNISH FLUID"), A PSEUDOCYST, TRUNNIONOSIS, AND LYSIS IN THE TROCHANTER, AROUND THE SLEEVE AND INFERIOR TO THE CUP WAS FOUND REQUIRING BONE GRAFTING. THE POSTERIOR CAPSULE WAS FOUND TO BE ATROPHIC. THE SURGEON REMARKS THAT THERE WAS NO WEAR FOUND ON THE HEAD AND LINER AND BELIEVES THE METALLOSIS OCCURRED FROM THE TRUNNION. THE TRUNNION AND MORSE TAPER WERE CLEANED AS MUCH AS POSSIBLE BEFORE THE NEW HEAD WAS IMPACTED. NO PRODUCT DEFICIENCY NOTED OF THE HOLE ELIMINATOR OR REASON FOR THE REVISION OF THIS PRODUCT.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12521059 ↗
• InjuryFeb 4, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS DISLOCATION AND METALLOSIS. ON (B)(6) 2007, THE PATIENT HAD A RIGHT PRESS-FIT TOTAL HIP ARTHROPLASTY TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE UTILIZED, INCLUDING S-ROM STEM. THE CUP WAS NOTED TO HAVE BEEN PLACED IN ABOUT 40-45 DEGREES OPEN ABDUCTION AND ABOUT 25 DEGREES ANTEVERSION THAT MATCHED HER VERSION ANATOMICALLY. THERE WERE NO COMPLICATIONS NOTED DURING THE SURGERY. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY WITH ACETABULAR CUP/LINER AND FEMORAL HEAD, TO ADDRESS FAILED RIGHT HIP, RECURRENT INSTABILITY, METALLOSIS WITH MILD ADVERSE REACTION TO METAL DEBRIS. THE PATIENT HAS HAD MULTIPLE DISLOCATION WHICH INCLUDED PAIN AND SWELLING PRIOR TO SURGERY. THE SURGEON INCLUDED IN HIS FINDINGS: MILD ADVERSE REACTION TO METAL DEBRIS, MOST LIKELY IMPINGEMENT OF THE NECK ON THE METAL LINER, MILD TRUNNIONOSIS ¿LITTLE BIT OF LYSIS AND/OR JUST STRESS SHIELDING IN THE BONE IN THE ACETABULUM, AND A PSEUDOTUMOR. THE ACETABULAR CUP WAS NOTED TO BE ¿SLIGHTLY MALPOSITIONED, SLIGHTLY VERTICAL, SLIGHTLY OVER-ANTEVERTED¿. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PRO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11278996 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD METAL ON METAL LINER. HIGHER NUMBERS OF IONS AND PAINFUL. TOOK OUT METAL PUT IN POLY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11185648 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH HIP PAIN. THE SURGEON WASHED OUT THE JOINT AND REMOVED THE POLY, HEAD AND STEM TO SWAP OUT. THIS PATIENT HAD A METAL ON METAL HIP WHICH CAUSED SOME METALOSIS. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 11131495 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A CONSTRAINED POLY FOR ADDED STABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 10329403 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTED HIP. CULTURES REVEALED THAT THE PATIENT HAD TB AND STAPH. THE SURGEON DECIDED IT BEST TO REMOVE ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10077712 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT WAS PRESENTED WITH INCREASING RIGHT HIP PAIN AND THEN REVISED FOR FAILED RIGHT TOTAL HIP ARTHROPLASTY METAL-ON-METAL DEPUY. OPERATIVE NOTES REPORTED THAT THERE WAS A SMALL AMOUNT OF FLUID ENCOUNTERED. EXAMINATION OF THE TRUNNION REVEALED TRUNNION WEAR. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9752257 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAS HAD ELEVATED METAL IONS AND PAIN IN THE HIP. MRI HAS SHOWN A MASS CONSISTENT WITH POSSIBLE PSEUDOTUMOR. PATIENT WAS THEN REVISED FOR RIGHT HIP METAL-ON-METAL HIP REPLACEMENT WITH RIGHT HIP PSEUDOTUMOR. OPERATIVE NOTES REPORTED THAT THE SHORT EXTERNAL ROTATORS APPEAR TO HAVE BEEN DETACHED AND THERE APPEARED TO BE FIBROSIS VERSUS CASEOUS NECROSIS OF THE PIRIFORMIS AS WELL AS THE GEMELLI MUSCLES. THERE WAS A LARGE AMOUNT OF CASEOUS NECROSIS CONSISTENT WITH PSEUDOTUMOR. DOI: (B)(6) 2007; DOR: (B)(6) 2018; RIGHT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Pain; Tissue Damage

  MAUDE report 9750880 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. PCS HAS NO ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORD PATIENT WAS REVISED TO ADDRESS PAIN. REVISION NOTES REPORTED THAT HEAD,LINER, AND STEM WERE REMOVED. PATIENT HAD TWISTING INJURY PRIOR TO THE REVISION. THERE WAS NO SIGNIFICANT ABNORMALITIES AND NO SIGNS OF INFECTION. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9708401 ↗
• MalfunctionDec 13, 2019Naturally Worn; Naturally Worn

  WORN HEAD WITHOUT REVISION. DATE OF IMPLANTATION: (B)(6) 2011. DATE OF REVISION: (B)(6) 2018 (HEAD AND LINER). DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT HIP). TREATMENTS: NONE.

  Patient problems: Discomfort; Edema; Inflammation; Osteolysis; Pain; Tissue Damage

  MAUDE report 9465454 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIS PATIENT UNDERWENT AN SROM MODULAR METAL ON METAL CONSTRUCT ROUGHLY 10 YEARS AGO - DONE BY DOCTOR. IT IS UNKNOWN WHETHER OR NOT THIS PATIENT'S PREVIOUS SURGERY WAS PERFORMED AT (B)(6) HOSPITAL OR AT (B)(6) ROCKIES AND IT IS UNKNOWN THE EXACT DATE. THE PATIENT LIVES IN (B)(6) AND RECENTLY HIS BLOOD WORK LAB RESULTS CAME BACK SHOWING A HIGHER INCIDENCE OF METAL ION COUNT IN THE BLOOD. HIS LABS ALSO SHOW AN INCREASED CHANCE OF INFECTION IN HIS HIP. HE WAS REVISED TODAY TO A POLY LINER AND METAL HEAD. THE METAL LINER AND PREVIOUS METAL WERE REMOVED.

  Patient problems: Extraskeletal ossification; Foreign Body Reaction; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 9361731 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. OPERATIVE NOTE REPORTED THICKENED YELLOW FLUID WHICH DID NOT APPEAR TO BE PURULENT AND IS MOST LIKELY INFLAMMATORY REACTION TO MOM. DOI: (B)(6) 2010; DOR: (B)(6) 2016; RIGHT HIP.

  Patient problems: Inflammation; No Code Available; Tissue Damage

  MAUDE report 8527260 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT I.D: (B)(6). ASSOCIATED STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL RADIOGRAPHIC EVALUATION ¿ PROGRESSION OF OSTEOLYSIS IN THE ACETABULUM AS WELL AS AROUND THE GREATER TROCHANTER. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE IN SEVERITY. EVENT IS RELATED TO DEVICE AND IS NOT RELATED TO PROCEDURE. DOI: (B)(6) 2008, DOE: (B)(6) 2018. (RIGHT HIP). AWAITING REVISION.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8479075 ↗
• InjuryMar 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. LINER IS NON-DEPUY. DOI: (B)(6) 2011 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8437414 ↗
• InjuryMar 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8431643 ↗
• InjuryMar 18, 2019Material Disintegration; Naturally Worn; Material Disintegration; Naturally Worn

  THE PPF AND IMPLANTS RECORDS RECEIVED ON JULY 31, 2018. PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8427908 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SROM, METAL ON METAL PINNACLE CONSTRUCT IMPLANTED OVER 10 YEARS AGO, TIME AND FACILITY UNKNOWN. PATIENT DISLOCATED HIP. THE SURGEON REMOVED ORIGINAL CUP/MOM/HEAD/ AND 2 SCREWS OF UNKNOWN LENGTH /REF # AND LOT #, AND RE-IMPLANTED A 58 PIN MULTIHOLE, 40 X 58 +4 N ALTRX, AND 40 + 9 HEAD. PATIENT WAS STABLE AFTER THIS. THE ORIGINAL STEM AND SLEEVE WERE RETAINED. DOI: OVER 10 YEARS AGO. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8357689 ↗