S-ROM 56-3518Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295178217), received between Jul 20, 2017 and Nov 15, 2024 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SURGEON REVISED A 18X13 30+4 S-ROM STEM AND A 50MM PINNACLE CUP. THE PINNACLE CUP WAS DETERMINED TO BE IMPLANTED TOO FLAT AND ANTEVERTED DURING A PREVIOUS OPERATION, WHICH HAD LED TO THE 32MM +6 CERAMIC BREAKING. THE S-ROM STEM WAS EXPLANTED AND A 18X13 36+12 STEM WAS IMPLANTED. THE CUP WAS EXPLANTED AND A 58MM REVISION CUP WITH A 36MM CERAMIC HEAD WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. THE NEW STEM PROVIDED GOOD STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20693888 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT HIP. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16776800 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS REPORTED THAT PATIENT POST 1ST REVISION PATIENT STILL COMPLAINTS OF PAIN, ACHES, LIMITATIONS WITH ACTIVITY, HIGH COBALT AND CHROMIUM LEVELS CONTINUED UNTIL DEATH. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT PATENT SUFFERED POST OPERATIVE ACUTE BLOOD LOSS ANEMIA. DOI: (B)(6) 2005 (STEM,SLEEVE). DOI: (B)(6) 2013 (CUP,SCREWS,APEX,LINER,HEAD). DOR: NONE REPORTED. (LEFT HIP).

  Patient problems: Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Pain

  MAUDE report 12333829 ↗
• InjuryOct 5, 2020Naturally Worn; Naturally Worn

  UNF AND PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INSTABILITY DUE TO FALL RESULTING TO DISLOCATION AND PAIN. OPERATIVE NOTE REPORTED HIP WAS FOUND DISLOCATED. THERE IS A MILD SCRATCHING ON THE TRUNNION AND ACETABULAR CUP. INTRA-OPERATIVE MENTIONED, THE CONSTRAINED LINER BENT. ANOTHER LINER WAS IMPACTED. X-RAY RESULT CONFIRMED THE DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10627908 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, INTRA-OPERATIVE REPORTED A SMALL FRACTURE AT THE BASE OF THE TROCHANTER DURING THE IMPACTION OF THE FEMUR. FOR THIS REASON THIS WAS EXPLANTED AND NEW PROSTHESIS WAS IMPLANTED. THIS WAS STABILIZED USING CERCLAGE WIRE. DOI: (B)(6) 2006; DOR: (B)(6) 2006 ; LEFT HIP.

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

  MAUDE report 10620231 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, NO REVISION WAS REPORTED. CLINIC VISIT NOTED COMPLAINS OF METAL POISONING, RASH ON LEGS, CRAMPING, HEADACHE, SPOTS IN VISION, PAIN, NAUSEA AND VOMITING. DOI: (B)(6) 2006. DOR: NOT REPORTED, (RIGHT HIP).

  Patient problems: Headache; Nausea; No Code Available; Pain; Rash; Vomiting

  MAUDE report 9831980 ↗
• InjuryMar 5, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGED LOOSENING OF STEM. DOI: (B)(6) 2011; DOR: (B)(6) 2015; (RIGHT HIP) SECOND REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8391634 ↗
• InjuryJan 4, 2019Corroded; Degraded; Corroded; Degraded

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS LEFT THA. OPERATIVE NOTES REPORTED A MINIMAL TRUNNIONOSIS OF THE TRUNNION, SOME OSTEOLYTIC FIBRINOUS MATERIAL WAS DEBRIDED, MINOR STAINING WERE NOTED AT THE ANTERIOR INFERIOR ACETABULAR MARGIN THIS WAS MINIMAL AND WAS DEBRIDED, SOME OSTEOLYTIC FIBRINOUS MATERIAL WAS ALSO DEBRIDED.

  Patient problems: Distress; Edema; Foreign Body Reaction; Injury; No Code Available; Osteolysis; Pain; Physical Asymmetry; Test Result

  MAUDE report 8218149 ↗
• InjuryJan 3, 2019Corroded; Degraded; Corroded; Degraded

  PATIENT WAS REVISED TO ADDRESS DISCOMFORT. UPDATE AD 07 DEC 2018: (B)(4) HAS BEEN RE-OPENED DUE TO MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS LYSIS AND PAIN OF RIGHT THR. REVISION NOTE REPORTED SOME SCARRING PRESENT IN THE MAXIMUS AND FASCIA, BULGING SOFT TISSUE INFLAMMATION NOTED FROM POSTERIOR CAPSULAR AREA AND DEEPER TISSUE WITH OBVIOUS INFLAMMATORY FROM LYTIC PROCESS, SLIGHT CLOUDY INFLAMMATORY FLUID AND SOME MILD TO MODERATE TRUNNIONOSIS. THE ACETABULUM HAS SLIGHT DEFICIENCY AND ALSO FAIRLY SHALLOW DUE TO PREVIOUS HIP REPLACEMENT PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body Reaction; Inflammation; Injury; No Code Available; Osteolysis; Pain; Scarring

  MAUDE report 8212874 ↗
• InjuryDec 21, 2018Malposition of Device; Malposition of Device

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS PAIN. LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT, WEAKNESS, LOOSE FEELING OR POPPING, DIFFICULTY AMBULATING, AND SOFT TISSUE/INFLAMMATORY RESPONSE. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN AND MALPOSITIONED CUP (NOT REVISED). PPF ALLEGES ABDUCTOR MUSCLE REPAIR AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORD FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAIN. THE CUP WAS IN ABOUT 5 DEGREES OF ANTEVERSION. THE STEM WAS IN ABOUT 10 DEGREES OF ANTEVERSION. DOI: (B)(6) 2012 - DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 8189244 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2012 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8160498 ↗
• InjuryDec 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND IMPLANT RECORD RECEIVED. PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 8160455 ↗
• InjuryOct 9, 2018Material Disintegration; Failure to Osseointegrate; Naturally Worn; Material Disintegration; Failure to Osseointegrate; Naturally Worn

  PFS REPORTED THAT THE PATIENT COMPLAINED THAT AROUND (B)(6) 2012 THERE WAS PAIN, ACHINESS, LIMITATION WITH ACTIVITY, FLUID BUILD UP, HIGH COBALT AND CHROMIUM LEVELS. PFS ALSO REPORTED THAT THE PATIENT WAS DECEASED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LEFT HIP PAIN, X-RAY EVIDENCE OF LOOSENING AND SOFT TISSUE PSEUDOTUMOR. THEN WAS REVISED FOR PAINFUL LEFT TOTAL HIP. OPERATIVE NOTES REPORTED THAT THERE WAS ABUNDANT TROCHANTERIC BURSITIS WITH BLACK STAINING. A SMALL TO MODERATE AMOUNT OF DESTRUCTION OF THE ABDUCTOR MUSCULATION. HETEROTOPIC OSSIFICATIONS WERE REMOVED. A LARGE AMOUNT OF BLACK STAINING WITH SYNOVITIS IN THE JOINT WAS DEBRIDED. THERE WAS MINIMAL BONY DESTRUCTION. CUP WAS REMOVED WITH MINIMAL DIFFICULTY. DOI: (B)(6) 2005. DOR: (B)(6) 2013. (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Extraskeletal ossification; Fatigue; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Inflammation; No Code Available; Numbness; Pain; Synovitis; Test Result

  MAUDE report 7948497 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES BONE FRACTURE AFTER FIRST REVISION. IT WAS ALSO INDICATED THAT CUP, LINER, HEAD AND STEM WERE REMOVED ON (B)(6) 2005. DOI: (B)(6) 2005- DOR: (B)(6) 2005 (LEFT HIP. (B)(4)- 1ST REVISION.

  Patient problems: Bone Fracture(s)

  MAUDE report 7792779 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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; Unspecified Infection

  MAUDE report 7780971 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AND DISCOMFORT IN HIP. IT BECAME INCREASINGLY PAIN TO WALK, MOVE THEIR LEGS, AND TO RISE FROM A SEATED POSITION. UPDATE: 11/15/12 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATED AD (B)(6): (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES LOOSENING OF CUP AND INFECTION. THERE IS NO REVISION NOTES PROVIDED. IT WAS INDICATED IN THE PPF THAT THE PLAINTIFF HAD A FIRST REVISION IN THE LEFT HIP ON (B)(6) 2015. UPDATED DATE OF REVISION. ADDED CUP, HOLE ELIMINATOR, SLEEVE AND STEM DUE TO ALLEGED INFECTION. DOI: (B)(6) 2005; DOR: (B)(6) 2015; (LEFT HIP).

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 7709919 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PFF AND STICKER SHEETS RECEIVED. PFF ALLEGES ELEVATED METAL ION. THERE WERE NO LABORATORY RESULT TO SUPPORT ELEVATED METAL IONS. DURING THE REVISION, THE IMPLANTS THAT WAS REMOVED WAS NOT SPECIFIED. DOI: (B)(6) 2010 FOR HEAD AND LINER; DOI: (B)(6) 2009 FOR STEM; DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: No Code Available; Not Applicable; Test Result

  MAUDE report 7618639 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE INDEX PROCEDURE. UNKNOWN HIP. ELEVATED IONS. DOI: (B)(6) 2008 : DOR: NOT REVISED, (UNKNOWN HIP).

  Patient problems: Hip Fracture; No Code Available

  MAUDE report 7446524 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS THIGH PAIN.

  Patient problems: Pain

  MAUDE report 7008487 ↗
• InjuryJul 20, 2017Malposition of Device; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS PAIN AND IMPINGEMENT. PER FOLLOW-UP WITH REP, THE IMPLANTS WERE REPOSITIONED DUE OT ORIGINAL MALPOSITION OF THE CUP AND STEM.

  Patient problems: No Code Available; Pain

  MAUDE report 6728889 ↗