S-ROM 52-3393Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295170990), received between Jan 9, 2017 and Mar 18, 2024 — classified as 22 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO STEM SUBSIDENCE AND REMOVED SROM STEM AND SLEEVE AND REVISED TO RECLAIM MOD STEM. IT WAS UNKNOWN THAT THERE WAS ANY SURGICAL DELAY. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2024, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920637 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONTACTED PATIENT VIA PHONE. PATIENT ANSWERED. LEFT HIP WAS IMPLANTED WITH PINNACLE IN (B)(6) 2004 AND RIGHT HIP WAS IMPLANTED WITH PINNACLE IN (B)(6) 2004. IN 2021 SHE HAD PAIN AND ELEVATED METAL ION LEVELS AND WAS RECOMMENDED FOR REVISION SURGERY AND HAS UNDERGONE THE REVISION. PATIENT WAS INTERESTED IN IF THE IMPLANTS WERE INVOLVED IN A RECALL. PATIENT WAS INFORMED PINNACLE WAS NOT PART OF THE ASR RECALL. PATIENT WAS INTERESTED IN COMPENSATION FOR THE REVISION SURGERIES. CONTACT INFORMATION WAS PROVIDED FOR THE LEGAL TEAM AND LEGAL TEAM WAS EMAILED THROUGH ECM. DOI: (B)(6) 2004. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14955307 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, POST REVISION CLINICAL VISIT REPORTED PAIN IN LEFT GROIN, LOWER BACK, WEAKNESS, NUMBNESS SENSATION, FLEXOR TENDINITIS, BONE LOSS IN THE PROXIMAL PORTION OF THE FEMUR, LOCAL TISSUE REACTION, ONGOING ILIOPSOAS TENDINOPATHY. X-RAYS REVEALED HETEROTOPIC BONY FORMATION ON THE GREATER TROCHANTER. DOI: JUN 11, 2018 ; DOR: UNKNOWN; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Calcium Deposits/Calcification; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Limb Fracture; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Unspecified Tissue Injury

  MAUDE report 14286703 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. PATIENT HAS UNDERGONE A FEW OTHER REVISIONS. DOI: SEVERAL YEARS AGO (STEM, CUP), DOI: (B)(6) 2021 (HEAD, LINER), DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13393392 ↗
• InjuryOct 1, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12561212 ↗
• InjurySep 30, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12555076 ↗
• InjurySep 28, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12539433 ↗
• InjuryAug 24, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12360932 ↗
• InjurySep 3, 2020Corroded; Degraded; Corroded; Degraded

  PFS ALLEGES THAT PATIENT COULD NOT WALK VERY WELL, LIMITED MOVEMENT OF ANY PHYSICAL ACTIVITY. X-RAYS RESULT STATED THAT THERE IS A FRACTURE FRAGMENT SEEN LATERAL TO THE FEMORAL NECK. DOI: (B)(6) 2007. DOR: (B)(6) 2018. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limb Fracture; Loss of Range of Motion; No Code Available; Osteolysis; Pain; Synovitis; Test Result

  MAUDE report 10488338 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD VERY HIGH HIP CENTER ON PRIMARY HIP PERFORMED IN (B)(6) 2019 AND AT THAT TIME PATIENT WAS LEFT SHORT. TODAY, A LONGER STEM WAS PLACED TO GET THE PATIENT BACK CLOSER TO EQUAL LEG LENGTHS. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10111316 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE AFFECTED SIDE IS THE LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9953665 ↗
• InjuryMar 10, 2020Degraded; Degraded

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED LEFT TOTAL HIP ARTHROPLASTY WITH PAIN AND SIGNS OF METALLOSIS. OPERATIVE FINDINGS INCLUDE SEVERE REACTIVE METALLOSIS, SOFT TISSUE DAMAGE, EROSION, SIGNIFICANT AMOUNT OF WEAR ON THE SURFACE OF THE HEAD AND BLACK METALLIC APPEARING RUST OVER THE TRUNNION. SAMPLES TAKEN FROM A CYST AND PSEUDOTUMOR WERE SENT TO THE LABORATORY FOR ANALYSIS. PREOPERATIVELY, THE PATIENT WAS SLIGHTLY LONGER ON THE RIGHT. DOI: (B)(6) 2004; DOR: (B)(6) 2016; RIGHT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Pocket Erosion; Tissue Damage

  MAUDE report 9813622 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2002 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Foreign Body Reaction; Test Result

  MAUDE report 9565388 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND PAIN. REVISION NOTES REPORTED SMALL AMOUNT OF CLOUDY SEROUS FLUID WITHIN THE BURSA AND DEEP TISSUES OF HIP CONSISTENT WITH SEROMA AND INFECTED SEROMA. PRIOR TO REVISION, THERE WAS NOTED SIGNIFICANT LOWER EXTREMITY EDEMA, SWELLING AND INABILITY TO AMBULATE. DOI: (B)(6) 2017 (HEAD & LINER). DOI: (B)(6) 2001 (CUP, STEM & SLEEVE). DOR: (B)(6) 2017 RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain; Seroma; Unspecified Infection

  MAUDE report 9564532 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. THERE WERE NO NEW ALLEGATION REPORTED FROM PPF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS CHRONIC DISCOMFORT AND BURSITIS VERSUS ABDUCTOR TENDON TEARS BUT OPERATIVE NOTES REPORTED THAT ABDUCTOR TENDON APPEAR TO BE INTACT. REVISION NOTE REPORTED METALLOSIS AND THE POSTERIOR ASPECT OF THE FEMORAL NECK WAS IMPINGING ON THE RETAINING RING ON THE ACETABULAR COMPONENT. DOI: (B)(6) 2013; DOR: (B)(6) 2015; (LEFT HIP) THIRD REVISION. PLEASE SEE (B)(4) FOR THE FIRST REVISION. PLEASE SEE (B)(4) FOR THE SECOND REVISION.

  Patient problems: Discomfort; Foreign Body Reaction; Joint Disorder; No Code Available

  MAUDE report 9120571 ↗
• InjuryJul 2, 2019Naturally Worn; Naturally Worn

  IT AS REPORTED THAT THE PATIENT HAS MULTI-LEVEL DEGENERATIVE CHANGES IN LUMBAR SPINE. USES NO WALKING AIDS TO AMBULATE. EXPERIENCED RIGHT HIP GROIN PAIN IN PREVIOUS MONTHS. THE TAPER ON THE FEMORAL STEM INDICATES MODERATE SIGNS OF WEAR. NO VISIBLE SIGNS OF METALLOSIS IN JOINT. ION STUDY ON (B)(6) 2019: CHROMIUM 2.1, COBALT 11.2, TITANIUM -. THE METAL INSERT AND FEMORAL HEAD WERE CHANGED. THE STEM HAS BEEN ADDED TO THE COMPLAINT DUE ELEVATED METAL IONS. DOI: (B)(6) 2004; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8752844 ↗
• InjuryApr 15, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2002; DOR: (B)(6) 2012; (RIGHT SIDE).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8514094 ↗
• InjuryApr 9, 2019Fracture; Fracture

  PPF ALLEGES INFECTION AND FRACTURE (COMPONENT). DOI: (B)(6) 2008 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result; Unspecified Infection

  MAUDE report 8497103 ↗
• InjuryMar 14, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (RIGHT SIDE).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8419871 ↗
• InjuryFeb 14, 2019Biocompatibility; Biocompatibility

  PATIENT REVISED FOR METALOSIS. UPDATE: 10/18/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. UPDATE AD 12 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND ELEVATED METAL IONS BEFORE FIRST REVISION. ADDED STEM TO ADDRESS ELEVATED METAL IONS.

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

  MAUDE report 8339271 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). LITIGATION ALLEGES THAT PATIENT EXPERIENCED HIP PAIN, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, IT IS ALLEGED THAT IMPLANT IS RELEASING METAL IONS INTO PATIENT'S BODY. UPDATE DEC 05, 2017: PFS AND MEDICAL RECORDS RECEIVED. PFS ALSO ALLEGES SUPERFICIAL THROMBOSIS, MUSCLE DAMAGE REQUIRING SURGICAL REPAIR, METALLOSIS AND PHYSICAL LIMITATIONS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, ELEVATED METAL IONS AND LARGE FLUID COLLECTIONS. REVISION NOTES REPORTED NO TISSUE AND BONE DESTRUCTION, CORROSIVE BLACK DEBRIS, METAL STAINING AND MINIMAL FLUID STAINING IN THE HIP. MRI REPORTED GREATER TROCHANTERIC BURSITIS. CLINIC NOTES REPORTED MUSCLE WEAKNESS AND STIFFNESS. ADDED SROM SLEEVE FOR THE REPORTED CORROSIVE BLACK DEBRIS. THIS COMPLAINT WAS UPDATED ON: DECEMBER 15, 2017. DOI: (B)(6) 2010, DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Host-Tissue Reaction; Limited Mobility Of The Implanted Joint; Pain; Thrombosis; Weakness

  MAUDE report 7159756 ↗
• InjuryJan 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6234214 ↗