S-ROM 1365-45-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295033851), received between Jan 9, 2017 and Feb 27, 2024 — classified as 1 death, 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR 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 REVISION: (B)(6) 2023 DATE OF EVENT: 01 FEB 2024. (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 18787087 ↗
• InjuryFeb 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18684841 ↗
• InjuryNov 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTES RECEIVED. ON (B)(6) 2023 MEDICAL RECORDS NOTE THE PATIENT HAD A FOLLOW-UP FOR STATUS POST BIKE ACCIDENT. THE PATIENT DISLOCATED THE RIGHT HIP, WHICH WAS REDUCED. PATIENT HAS A QUITE A BIT OF PAIN ALONG MEDICAL SIDE OF KNEE. PATIENT IS STATUS POST RIGHT HIP, 7 YEARS PRIOR, AND STATUS POST RIGHT KNEE ARTHROPLASTY, 3 YEARS PRIOR. RADIOGRAPHS NOTE A WELL PLACED RIGHT SROM PROSTHETIC, WHICH IS STABLE. THERE IS MCL RUPTURE AT LEAST SECOND-DEGREE. THE PLAN IS FOR THE PATIENT TO USE A KNEE BRACE. ON (B)(6) 2023 MEDICAL RECORDS NOTE, THE PATIENT HAD RIGHT KNEE MEDICAL COLLATERAL LIGAMENT SPRAIN AND REVIEW OF PREVIOUS RIGHT HIP DISLOCATION. IMPRESSION, STATUS POST RIGHT HIP DISLOCATION, DOING WELL, AND STATUS POST RIGHT KNEE MCL SPRAIN, STATUS POST KNEE REPLACEMENT, DOING WELL. (B)(4) IS FOR RIGHT KNEE. AFTER REVIEW OF THE CLINICAL DATA BASE, THE REPORTED KNEE PAIN AND MCL SPRAIN ARE NOTED TO BE NOT DEVICE OR PROCEDURE RELATED AS PATIENT WAS INVOLVED IN A BIKE ACCIDENT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 18149045 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT HIP). TREATMENT: I&D AND REVISION (HEAD AND LINER WERE REVISED).

  Patient problems: Unspecified Infection

  MAUDE report 17641786 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: REVISION; STEM AND HEAD WERE REVISED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 16522584 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP) . TREATMENT: REVISION; HEAD AND LINER WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16442822 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING THIGH PAIN. TOOK STEM OUT AND REPLACED WITH ANOTHER STEM THAT WAS MANIPULATED. DOI: (B)(6) 2003. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12916826 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION LEFT THA - INITIAL EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2007. DATE OF REVISION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 12283019 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT HIP DISLOCATION - INITIAL EVENT IS SERIOUS AND IS CONSIDERED. THERE IS REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005, DATE OF REVISION: (B)(6) 2014 (CUP, LINER, AND HEAD), DATE OF EVENT (ONSET): (B)(6) 2021 (LEFT HIP). TREATMENT: CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 12281121 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS UNSURE OF THE PATIENTS ORIGINAL SURGERY DATE, WHO PERFORMED THE SURGERY, OR WHERE IT WAS DONE. PATIENT WAS SUFFERING FROM BURSITIS AND THE CASE WAS BOARDED AS A BURSECTOMY WITH POSSIBLE HEAD AND LINER EXCHANGE. SURGEON INFORMED THE PATIENT THAT IF HE WENT INTO THE HIP CAPSULE HE WOULD CHANGE THE HEAD AND LINER. ONCE GETTING INTO THE HIP, HE FELT THE PATIENT WOULD BENEFIT FROM GETTING THE HEAD AND LINER EXCHANGED. A 40MM +9 HEAD AND 40X58 +4 NEUTRAL LINER WERE REMOVED. THE SURGEON OPTED TO IMPLANT A 36X58 +4 NEUTRAL LINER BECAUSE HE WANTED TO HAVE A CERAMIC HEAD AS AN OPTION. EVEN THOUGH HE WAS TOLD IT WAS OFF LABEL, HE FELT THE FEMORAL NECK WAS IN GOOD ENOUGH CONDITION TO RECEIVE A 36 CERAMIC. A TRAIL REDUCTION WAS PERFORMED WITH A 36MM +9. IT WAS FOUND TO BE STABLE, SO THE REAL HEAD WAS OPENED AND IMPLANTED. THE HIP WAS REDUCED AND THE CLOSING PROCESS BEGAN. DOI: UNKNOWN; DOR: (B)(6) 2021; (RIGHT HIP).

  Patient problems: Inflammation

  MAUDE report 12173125 ↗
• InjuryMar 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2013, THE PATIENT RECEIVED A PRIMARY TOTAL HIP REPLACEMENT TO ADDRESS END-STAGE OSTEOARTHRITIS OF THE LEFT HIP. A DEPUY PINNACLE CUP S-ROM STEM CONSTRUCT WAS PLACED, WITH CERAMIC ON POLYETHYLENE ARTICULATION. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2013, PATIENT'S LEFT HIP WAS REVISED TO ADDRESS HIP RECURRENT INSTABILITY WITH MULTIPLE DISLOCATIONS. PATIENT INITIALLY DID WELL FOLLOWING PRIMARY, UNTIL HE SUSTAINED A TRAUMATIC FALL, WHICH LED TO A POSTERIOR DISLOCATION OF THE HIP. TWO ADDITIONAL DISLOCATIONS OCCURRED FOLLOWING THIS, WHILE PERFORMING FLEXION TYPE ACTIVITIES. THE PATIENT'S STEM AND CUP WERE DETERMINED TO BE WELL-FIXED, AND IN ADEQUATE POSITION/VERSION. CERAMIC HEAD SHOWED EVIDENCE OF METAL TRANSFER FROM THE MULTIPLE DISLOCATIONS. HEAD AND LINER WERE REVISED, WITH SELECTION OF A TEN DEGREE +4 LATERALIZED FACE CHANGING POLYETHYLENE ACETABULAR LINER, POSITIONED TO TWO O'CLOCK ORIENTATION. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2015, PATIENT RECEIVED A CLOSED REDUCTION OF THE LEFT DISLOCATED HIP WHILE UNDER ANESTHESIA. THERE WERE NO REPORTED COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. IT IS NOTEWORTHY THAT NO PRODUCTS WERE REVISED, AND THIS EVENT WITH

  Patient problems: Joint Dislocation

  MAUDE report 11594486 ↗
• DeathNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEATH, SECONDARY TO POSSIBLE GASTROINTESTINAL BLEED EVENT SERIOUS AND IS CONSIDERED SEVERE/FATAL. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION (NON-STUDY HIP): (B)(6) 2020. DATE OF EVENT (ONSET): OCTOBER 2020 (DAY UNKNOWN). (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10838265 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM LETTER RECEIVED. PATIENT ALLEGES CONSTANT PAIN, WALKING DIFFICULTY AND ABSCESS WHICH RESULTED IN A REVISION OF THE RIGHT HIP. DOI: (B)(6) 2009 - DOR: (B)(6) 2020 (RIGHT HIP).

  Patient problems: Abscess; Anxiety; Foreign Body Reaction; Metal Related Pathology; No Code Available; Pain

  MAUDE report 10788250 ↗
• InjuryMar 3, 2020Corroded; Corroded

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED RIGHT METAL ON METAL TOTAL HIP ARTHROPLASTY WITH ALVAL/ FLUID COLLECTION NOTED ON MRI AND PAIN. PREOP WORKUP FOR INFECTION WAS NEGATIVE. INTRAOPERATIVELY, THERE WAS ABOUT 20CC OF YELLOW FLUID THAT WAS SUCTIONED ALONG WITH GREY/ METAL STAINED REACTIVE TISSUE PRESENT. THERE WAS NO SIGN OF LOOSENING ON THE STEM AND SHELL AND THE TRUNNION HAD NO OBVIOUS DAMAGE/ FRACTURE/ WEAR. THERE WAS EXTENSIVE SCAR TISSUE AROUND THE CUP THAT WAS DEBRIDED. THERE WAS NO EVIDENCE OF INFECTION. THERE WAS NO BLACK STAINING INSIDE THE METAL HEAD AND ON THE BACK OF THE LINER. DOI: (B)(6) 2010. DOR: (B)(6) 2018, (RIGHT HIP).

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9780367 ↗
• InjuryOct 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE CLAIM LETTER AND MEDICAL RECORDS RECEIVED. CLAIM LETTER ALLEGES SEVERE PAIN, IMPAIRED MOBILITY, STIFFNESS, WALKING DIFFICULTY, MENTAL ANGUISH, DEPRESSION AND FRUSTRATION, SWELLING, NUMBNESS, WEAKNESS AND EMOTIONAL DISTRESS. WITH REGARD TO THIS THE PATIENT IS SEEKING COMPENSATION. AFTER REVIEW OF MEDICAL RECORDS, CLINICAL VISIT REPORTED 4 MONTHS AFTER REVISION PATIENT SLEPT AND DEVELOPED PAIN AND TROCHANTERIC SWELLING, BURSITIS AND HEMATOMA. CLINICAL VISIT ON (B)(6) 2019 LUMP ON THE RIGHT HIP RESULTING TO PAIN, HIP POP IN AND OUT OF PLACE. DOI: (B)(6) 2019; DOR: NOT REVISE; RIGHT HIP. THIS COMPLAINT IS LINK TO (B)(4) (1ST REVISION).

  Patient problems: Edema; Hematoma; Host-Tissue Reaction; Hypoesthesia; Joint Dislocation; Limited Mobility Of The Implanted Joint; Pain; Weakness

  MAUDE report 9262079 ↗
• InjuryOct 15, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007; DOR: (B)(6) 2010 (LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR THE RIGHT HIP. THIS PC IS FOR THE FIRST REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE SECOND REVISION.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9192858 ↗
• InjuryMay 9, 2019Biocompatibility; Device Dislodged or Dislocated; Biocompatibility; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS AFTER THE FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available; Test Result

  MAUDE report 8594704 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF HAS NO ALLEGATION. LABORATORY REPORTED IN MICROBIOLOGY OF RIGHT HIP ABSCESS AND RIGHT HIP ARTHROPLASTY INFECTION.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 8455294 ↗
• InjuryMar 21, 2019Naturally Worn; Naturally Worn

  LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PLAINTIFFS BLOOD. AS A RESULT HE BEGAN EXPERIENCING SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND INJURY. DOI: (B)(6) 2008; DOR: (B)(6) 2017; LEFT HIP. THIS PC CAPTURES THE LEFT HIP. PATIENT IS BILATERAL.

  Patient problems: Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 8439245 ↗
• InjuryJan 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT HAD DISLOCATED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8294146 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PINNACLE METAL LINER AND SROM METAL HEAD WERE REMOVED AND REPLACED WITH A 56MM X 40MM +4/100 ALTRX LINER AND A 40MM +12 M-SPEC SROM HEAD.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8288959 ↗
• InjuryJan 7, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8223400 ↗
• InjuryDec 27, 2017Material Disintegration; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Material Disintegration; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  PINNACLE LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PLAINTIFFS BLOOD. AS A RESULT HE BEGAN EXPERIENCING SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND INJURY.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; No Code Available; Not Applicable; Osteolysis; Pain

  MAUDE report 7147900 ↗
• InjuryDec 7, 2017Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN AND LIMP. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. REVISION NOTES REPORTED METALLIC TINGED FLUID, SIGNIFICANT METALLOSIS WITHIN THE JOINT, AND LARGE AMOUNT OF METALLIC DEBRIS.

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

  MAUDE report 7095698 ↗
• InjuryJan 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6234232 ↗