SOLUTION SYSTEM 1257-50-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295019916), received between Oct 26, 2017 and Mar 6, 2023 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP WAS EXPLANTED FOR INFECTION. TEMPORARY SPACER WAS PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16488550 ↗
• MalfunctionAug 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  5.0 SCREWS FROM LOANER SET 229A/6 WERE OPENED AND FOUND TO BE CONTAMINATED DUE TO PEEL PACK SEAL BROKEN AND SCREW PROTRUDING. COULD NOT USE AND OTHERS WERE OPENED AND USED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324601 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUP, LINER AND SCREWS WERE IMPLANTED DURING A REVISION PROCEDURE. IT IS UNKNOWN IF THE ORIGINAL IMPLANTS WERE DEPUY. THE PATIENT HAD EXTENSIVE BONE LOSS AND THE FAILED TO OSSEOINTEGRATE WITH THE CUP AND SCREWS THAT WERE IMPLANTED AT REVISION (DOI). A DECISION WAS MADE TO CONVERT TO PROTRUSIO CAGE. DOI: (B)(6) 2021; DOR: (B)(6) 2021 LEFT HIP.

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

  MAUDE report 11521306 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES PROVIDE INFORMATION THAT THE PRIMARY LEFT THA INCLUDED AN ASR CUP AND HEAD, A ZTT FEMORAL SLEEVE, AND AN UNK DEPUY FEMORAL STEM. DATE OF IMPLANTATION AND PART/LOT INFORMATION WERE NOT PROVIDED. THESE PRODUCTS HAVE NOT BEEN PREVIOUSLY REPORTED. RECORDS INDICATE THE PRIMARY THA PROCEDURE OCCURRED 10 YEARS EARLIER BY A DR. EDWARDS IN LARAMIE, WYOMING. DOR: (B)(6) 2020: PATIENT RECEIVED A COMPLETE LEFT THR TO TREAT PAIN AND DISCOMFORT SECONDARY TO ARMD AND MASSIVE ACETABULAR AND FEMORAL OSTEOLYSIS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED STAINED PERIARTICULAR SYNOVIAL TISSUE AND FLUID CONSISTENT WITH METALLOSIS AND FOREIGN BODY REACTION. THE PSEUDOCAPSULE WAS DEBRIDED. THERE WAS SOME DEFICIENCY OF THE GLUTEUS MEDIUS, WHICH WAS REPAIRED. THE ASR CUP WAS MALPOSITIONED AND HAD SIGNIFICANT ECCENTRIC WEAR WHICH PRODUCED THE METALLOSIS. UPON REMOVAL OF THE ASR CUP, THE SURGEON IDENTIFIED SIGNIFICANT RETROACETABULAR OSTEOLYSIS WHICH WAS REMOVED AND RECONSTRUCTED WITH FRESH FROZEN ALLOGRAFT. THE OSTEOLYTIC LESIONS IN THE ISCHIUM, PUBIS, AND SUPERIOR REGIONS OF THE ACETABULUM, WHICH REQUIRED THE REVISION CUP TO BE SECURED WITH SCREWS. THE ZTT FEMORAL

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 10072789 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECENT DEEP VEIN THROMBOSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT HIP).

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10072368 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED PAIN, SEVERE SEPSIS, SEPTICEMIA,INFECTION. GENERALIZED WEAKNESS, HYPOXIA, APNEA, ASTHMA, AND PNEUMONIA. DOI: (B)(6) 2016. DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Apnea; No Code Available; Pain; Pneumonia; Sepsis; Unspecified Infection; Weakness

  MAUDE report 9909107 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR PAINFUL LEFT THA. CUP AND STEM REPORTED ON (B)(4). DOI: (B)(6) 2005; DOR: (B)(6) 2008; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9519407 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT SUPERFICIAL HEMATOMA. THE PATIENT HAD PREVIOUSLY UNDERGONE 5 TO 6 ASPIRATIONS TO TREAT THE HEMATOMA. OPERATIVE FINDINGS INCLUDE A LARGE HEMATOMA AND A RENT IN THE DEEP TISSUE ANTERIOR TO THE TROCHANTER AND EXTENDING INTO THE DEEP AREA OF THE HIP. DOI: (B)(6) 2010 - DOR: NO REVISION - DOE: (B)(6) 2011 (LEFT HIP).

  Patient problems: Hematoma; No Code Available

  MAUDE report 8716731 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT SUPERFICIAL HEMATOMA. THE PATIENT HAD PREVIOUSLY UNDERGONE 5 TO 6 ASPIRATIONS TO TREAT THE HEMATOMA. OPERATIVE FINDINGS INCLUDE A LARGE HEMATOMA AND A RENT IN THE DEEP TISSUE ANTERIOR TO THE TROCHANTER AND EXTENDING INTO THE DEEP AREA OF THE HIP. DOI: (B)(6) 2010 - DOR: NO REVISION - DOE: (B)(6) 2011 (LEFT HIP).

  Patient problems: Hematoma; No Code Available

  MAUDE report 8716730 ↗
• InjuryApr 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION WITH BONE ALLOGRAFTING. OPERATIVE NOTE REPORTED A LARGE ABSCESS IN THE SUBCUTANEOUS TISSUE, DEAD TISSUES AND PUS IN THE ACETABULAR COMPONENT. DEAD BONE WERE REMOVED FROM THE FEMUR; HOWEVER, STEM WAS INTACT THUS LEFT IN SITU. ANTIBIOTIC SPACER WAS IMPLANTED INTO THE AFFECTED SIDE. DOI: (B)(6) 2008; DOR: (B)(6) 2009; LEFT HIP.

  Patient problems: Abscess; Injury; Necrosis; No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 8543908 ↗
• InjuryApr 5, 2019Loss of Osseointegration; Loss of Osseointegration

  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. UPDATE: SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES THAT THE PATIENT FELT LIKE THERE WAS SCRAPING SENSATION IN HIS HIP, WALKING DIFFICULTY AND FALLING DOWN ON OCCASION. SURGEON RECOMMENDED REVISION SURGERY DUE TO LOOSE COMPONENT AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS CUP LOOSENING, METALLOSIS AND INSTABILITY. REVISION NOTES REPORTED THAT HIP WAS FOUND TO BE DISLOCATED, SYNOVIAL SCARRING, AND GROSSLY LOOSE CUP. IT WAS ALSO FOUND THAT THE STEM IS 20 DEGREES RETROVERTED. THE SLEEVE WAS LEFT IN PLACE AND STEM WAS ROTATED OVER 40 DEGREES TO PROVIDE APPROPRIATE ANTEVERSION THEN WAS RE-INSERTED. PATHOLOGY REPORT IS POSITIVE FOR ACUTE INFLAMMATION. LAB DATA SHOWS METAL ION LEVELS WERE ABOVE 7 PPB. DOI: (B)(6) 2007; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Scar Tissue; Tissue Damage

  MAUDE report 8486598 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2009, DOR: (B)(6) 2014, (RIGHT HIP). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8424722 ↗
• InjuryMar 11, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2014; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8408665 ↗
• InjuryMar 11, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2014; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8408662 ↗
• InjuryJan 29, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND FRACTURE OF COMPONENT. DOI: (B)(6) 2008 - DOR: (B)(6) 2008 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 8284526 ↗
• InjuryJan 29, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND FRACTURE OF COMPONENT. DOI: (B)(6) 2008 - DOR: (B)(6) 2008 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 8284515 ↗
• InjuryJan 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN. LITIGATION ALLEGES DISCOMFORT AND DIFFICULTY AMBULATING. UPDATE AD (B)(6) 2018 RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR AND ELEVATED METAL. IONS.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain; Tissue Damage

  MAUDE report 8230809 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT SUFFERS TOXIC COBALT CHROMIUM METAL IONS, PAIN, DISCOMFORT, AND INFLAMMATION. UPDATE (B)(6) 2015: PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES POPPING, GRINDING, AND CLICKING. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING "INVESIGATION". IT SHOULD BE NOTED THAT THE FIRST PAGE OF THE PRIMARY OPERATIVE NOTE WASN'T INCLUDED. THE COMPLAINT WAS UPDATED ON 11/9/2015. UPDATE AD 4 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION, METAL WEAR AND METALLOSIS. ADDED LAWYER, FACILITY NAME, EVENT DATE, EXPLANT DATE, ACCOUNT NAME, REVISION SURGEON, PATIENT HARMS AND THE PRODUCT DETAILS OF LINER, HEAD AND STEM. UPDATED PATIENT'S INITIALS. DOI: (B)(6) 2006; DOR: (B)(6) 2015; (RIGHT HIP). PATIENT IS BILATERAL; PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Discomfort; Inflammation; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8221656 ↗
• InjuryDec 6, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AROUND THE HIP JOINT, DIFFICULTY WALKING, MUSCLE AND BONE SEPARATION AND SWELLING. UPDATE AFTER REVIEW OF THE MEDICAL RECORDS, THE REVISION SURGERY NOTES METALLOSIS, AND THE PATIENT DISLOCATED ONCE. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND LOOSENING OF CUP. DOI: (B)(6) 2007, DOR: AUG 24, 2015, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8137194 ↗
• InjuryOct 1, 2018Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  IT WAS REPORTED THAT THE CUP CAME LOOSE AT THE BONE TO IMPLANT INTERFACE AND BOTH PERIPHERAL SCREWS BROKE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 7923463 ↗
• InjurySep 4, 2018Loss of Osseointegration; Loss of Osseointegration

  REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS A PAINFUL LEG. A LITTLE BIT OF CORROSION WAS NOTICED INSIDE THE FEMORAL HEAD. DOI: (B)(6) 1998 (STEM & SLEEVE); (B)(6) 2010 (HEAD & LINER); DOR: (B)(6) 2012; (LEFT HIP). UPDATE AD 25 APRIL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, LOOSENING OF CUP, INFECTION AND LOOSENING OF STEM. ADDED BONE SCREWS DUE TO ALLEGED LOOSENING OF CUP. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2010; DOR: (B)(6) 2012; (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7842060 ↗
• InjurySep 4, 2018Loss of Osseointegration; Loss of Osseointegration

  REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS A PAINFUL LEG. A LITTLE BIT OF CORROSION WAS NOTICED INSIDE THE FEMORAL HEAD. DOI: (B)(6) 1998 (STEM & SLEEVE); (B)(6) 2010 (HEAD & LINER) - DOR: (B)(6) 2012 (LEFT HIP). UPDATE AD 25 APRIL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, LOOSENING OF CUP, INFECTION AND LOOSENING OF STEM. ADDED BONE SCREWS DUE TO ALLEGED LOOSENING OF CUP. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2010 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7842043 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE THAT DEFECTIVE PRODUCT WAS THE CAUSE OF ANY PAIN OR OTHER PROBLEMS SHE MAY EXPERIENCE. DOI: (B)(6) 2007 DOR: NONE REPORTED (RIGHT HIP). PATIENT IS RESIDES IN (B)(6). UPDATE: 10/18/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. AS THE LITIGATION HAS ALREADY BEEN REPORTED, AND THERE IS NO REPORTED SERIOUS INJURY OR MALFUNCTION (PATIENT HAS NOT BEEN REVISED), THE REPORTING REQUIREMENTS HAVE BEEN MET. EVEN THOUGH PART/LOT INFORMATION WAS PROVIDED IT IS UNCLEAR WHAT PRODUCTS ARE AT ISSUE AS THE PATIENT HAS NOT BEEN REVISED THEREFORE THE PRODUCT PAGE WILL BE LEFT AS UNKNOWN UNTIL FURTHER INFORMATION IS RECEIVED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 19 APRIL 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF, STICKER SHEETS AND MEDICAL RECORDS. THERE WERE NO NEW ALLEGATION IN PPF NOR IN THE MEDICAL RECORDS. HOWEVER, IN THE PREVIOUS PFS A

  Patient problems: Pain

  MAUDE report 7788359 ↗
• InjuryAug 15, 2018Fracture; Fracture

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRICTION AND WEAR, LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS, PAIN, DISCOMFORT, INJURY AND INFLAMMATION. DOI: (B)(6) 2005; DOR: (B)(6) 2016; LEFT HIP (PINNACLE). PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES OSTEOLYSIS, FORMATION OF SCAR TISSUE. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED OF GREY-COLORED TISSUE THROUGHOUT THE HIP JOINT WITH SOME AMOUNT OF METAL DEBRIS. THE CUP NOTED TO BE GROSSLY LOOSE AND MULTIPLE SCREWS WERE BROKEN. RADIOGRAPHS REPORTED OF LOOSENING OF ACETABULAR COMPONENT.

  Patient problems: Discomfort; Host-Tissue Reaction; Inflammation; Injury; Not Applicable; Pain

  MAUDE report 7786701 ↗
• InjuryAug 2, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND COMPONENT FRACTURE. DOI: (B)(6) 2008; DOR: NOT REPORTED; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 7742150 ↗