S-ROM 56-3622Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295178248), received between Dec 14, 2017 and Jan 13, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16157987 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE BONE FRACTURE. EVENT IS SERIOUS. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. ON (B)(6) 2010, THE PATIENT UNDERWENT A PRIMARY RIGHT HIP ARTHROPLASTY DUE TO AVASCULAR NECROSIS. DURING IMPACTION OF THE ACETABULAR CUP, A SMALL FRACTURE WAS NOTICED IN THE POSTERIOR WALL. THE ACETABULAR FRACTURE WAS CORRECTED INTRA-OPERATIVELY WITH A 5-HOLE SMALL FRAGMENT PELVIC RECONSTRUCTION PLATE ALONG WITH FOUR SCREWS. DATE OF IMPLANTATION: (B)(6) 2010, DATE OF EVENT (ONSET): (B)(6) 2010, (RIGHT HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 11342758 ↗
• InjuryDec 17, 2020Degraded; Degraded

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE LOCAL TISSUE REACTION/HIGH COBALT LEVEL 5.3 MCG/L. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT HIP). TREATMENT: HIP REVISED ON (B)(6) 2020, OF HEAD AND LINER.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 11027029 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP; SURGEON EXPLANTED COMPONENTS AND IMPLANTED PROSTALAC SPACER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10853707 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

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

  MAUDE report 10587315 ↗
• InjuryDec 19, 2019Degraded; Fracture; Degraded; Fracture

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2010. DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 9496896 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN 2006, THIS PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY USING PINNACLE METAL ON METAL BEARING, AND AN SROM STEM. PATIENT HAS PRESENTED WITH PAIN AT RIGHT HIP AND IS BEING REVISED. STEM, METAL LINER, METAL HEAD ARE ALL EXPLANTED, AND NEW STEM HEAD, AND ALTREX LINER ARE PLACED. THE ZTT SLEEVE WAS RETAINED IN THE PATIENT AS WAS THE PINNACLE CUP. NO IMPLANTS ARE BEING SENT BACK TO CORPORATE. DOI: 2006; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9163061 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS METAL ON METAL LEFT TOTAL HIP REPLACEMENT USING PINNACLE CUP AND SROM STEM. PATIENT HAS PRESENTED WITH PAIN AND IS BEING BROUGHT TO THE OR FOR TOTAL HIP REVISION. ALTREX LINER IS INSERTER, AS IN A NEW SROM STEM AS WELL AS HEAD. CUP, ZTT SLEEVE ARE ALL RETAINED. DOI: AUG 3, 2006. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8666688 ↗
• InjuryApr 17, 2019Migration; Migration

  IT WAS REPORTED THAT THE FEMORAL STEM SUBSIDED POST OP. LEG LENGTH DISCREPANCY LED TO THE REVISION. REPLACED WITH A 40MM X15.5 HEAD. LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8524991 ↗
• InjuryJan 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2005 - DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain; Test Result

  MAUDE report 8230716 ↗
• InjuryDec 28, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, WEAKNESS, AND DIFFICULTY WALKING. UPDATE 06 JUL 2018 RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fatigue; Metal Related Pathology; Pain; Test Result; Weakness

  MAUDE report 8202328 ↗
• InjuryOct 10, 2018Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, METAL-ON-METAL DISEASE, DISCOLORED TISSUE AND FLUID, AND PAINFUL HIP. UPDATE AD 27 APRIL 2018: PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. THE STEM WAS ADDED TO THE IMPACTED PRODUCTS DUE TO ELEVATED METAL IONS.

  Patient problems: Not Applicable; Osteolysis; Pain; Test Result

  MAUDE report 7951198 ↗
• InjuryMar 21, 2018Loss of Osseointegration; Loss of Osseointegration

  CLINICAL ADVERSE EVENT RECEIVED FOR CELLULITIS EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT NOT RELATED TO DEVICE. EVENT IS RELATED TO PROCEDURE. DOI: (B)(6) 2014, DOE: (B)(6) 2014, (RIGHT KNEE). ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE COMPONENTS LISTED ON (B)(4) CORRECTLY REFLECT THE OPERATIVE NOTES. ON (B)(6) 2014, THE PATIENT EXPERIENCED A WITNESSED FALL AND LEFT THE FACILITY AGAINST MEDICAL ADVICE AND RETURNED TO THE FACILITY ON THE SAME DAY DUE TO A PERIPROSTHETIC FEMUR FRACTURE. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION OF A RIGHT TOTAL HIP ARTHROPLASTY DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO LOOSENING AND PERIPROSTHETIC FRACTURE. THE LOOSENING IS INDICATED TO BE THE FEMORAL COMPONENT. THE SURGEON NOTED THE PROXIMAL CALCAR FRACTURE AREA WAS REPAIRED WITH SEVERAL 16-GAUGE STAINLESS STEEL WIRES.

  Patient problems: Bone Fracture(s); Cellulitis; Inadequate Osseointegration

  MAUDE report 7356799 ↗
• InjuryDec 14, 2017Corroded; Malposition of Device; Corroded; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS A PAINFUL HIP. UPDATE NOV 14, 2017: PFS AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES RIGHT HIP PAIN, POPPING IN THE RIGHT HIP, DISCOMFORT AND INSTABILITY WHEN WALKING. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATION. REVISION NOTE STATES, THE TRUNNION WAS CLEAN AND INTACT WITH MINIMAL CORROSION ON THE TRUNNION. IT ALSO SHOWED THAT THE STEM WAS IN ABOUT 15 DEGREES OF ANTEVERSION. ADDED UNKNOWN STEM FOR THE CORROSION AND COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON NOV 29, 2017. UPDATE NOV 30, 2017: PFS AND MEDICAL RECORDS RECEIVED. THERE IS NO NEW INFORMATION ADDED. THIS COMPLAINT WAS UPDATED ON: DEC 12, 2017.

  Patient problems: Bruise/Contusion; Discomfort; Fall; Hematoma; Injury; Joint Dislocation; Joint Disorder; Not Applicable; Pain; Swelling

  MAUDE report 7116551 ↗