SOLUTION SYSTEM 1257-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295019893), received between Nov 9, 2017 and Aug 13, 2024 — classified as 26 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED RIGHT THA. REMOVED THE CONSTRAINED LINER, TWO 5.0 PERIPHERAL SCREWS. REPLACED WITH A NEW CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19973786 ↗
• InjuryOct 31, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION OF HARDWARE DUE TO LOOSE CUP. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15699642 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 10 MAR 2021. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AND WAS REVISED DUE TO FAILED LEFT THA WITH MEDICAL PROTRUSION OF THE ACETABULUM INTO THE PELVIS. OPERATIVE NOTES REPORTED THAT THE ACETABULUM HAD MEDIALIZED INTO THE PELVIS AND THE BALL WAS SITTING DEEP IN THE PELVIS. INSPECTION OF THE ACETABULUM, THERE WAS NOTED TO BE ANTERIOR AND POSTERIOR COLUMNS INTACT, HOWEVER THERE WAS A SIGNIFICANT MEDIAL WALL, ANTERIOR WALL AND POSTERIOR WALL DEFECT. THERE WAS A SIGNIFICANT MEDIAL BONE GRAFT THAT HAD NOT INCORPORATED AND WAS LOOSE IN THE CAVITY. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 11558771 ↗
• 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. (B)(6) IN (B)(6) . 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 SLEEVE WA

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 10072781 ↗
• 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. (B)(6) IN (B)(6). 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 SLEEVE WAS

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10072353 ↗
• 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 9909106 ↗
• 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 9519405 ↗
• InjuryNov 14, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENTS ACETABULAR COMPONENT FAILED AND COLLAPSED INTO THE PATIENTS PELVIS. DR (B)(6) WAS UNSURE OF ORIGINAL IMPLANT DATE, BUT THE FIRST REVISION DATE WAS (B)(6) 2019. DR LES PERFORMED THAT REVISION AS WELL. THE PINNACLE REVISION CUP WAS LOOSENED AT BONE TO IMPLANT INTERFACE AND WAS TAKEN OUT, ALONG WITH THE SCREWS, LINER, AND 40MM +15.5 FEMORAL HEAD. DR (B)(6) PREPARED THE ACETABULUM FOR A 74MM REVISION PINNACLE CUP AND PLACED SEVERAL SCREWS IN TO SECURE THE CUP. A 40MM +5 FEMORAL HEAD WAS TRIALED AND FOUND TO BE SATISFACTORY. THE REAL HEAD WAS IMPLANTED AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9324265 ↗
• InjuryOct 17, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF AND MEDICAL RECORDS RECEIVE. PPF ALLEGED LOOSENING OF THE CUP, DISLOCATION, AND ELEVATED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE LOOSENING OF ACETABULAR COMPONENT, SOFT TISSUE LOSS, METALLOSIS, AND DISLOCATION. OPERATIVE NOTE REPORTED OF MASSIVE SOFT TISSUE DESTRUCTION AND BROKEN 2 SCREWS. THERE WAS NO LOT NUMBER PROVIDED FOR THE BROKEN SCREWS. DOI: (B)(6) 2012. DOR: (B)(6) 2016, (RIGHT HIP). FOURTH REVISION. (B)(4), (RIGHT HIP) 1ST REVISION. (B)(4), (RIGHT HIP) 2ND REVISION. (B)(4), (RIGHT HIP) 3RD REVISION.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Necrosis; No Code Available; Tissue Damage

  MAUDE report 9204467 ↗
• InjuryOct 9, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF AND MEDICAL RECORDS RECEIVE. PPF ALLEGED LOOSENING OF THE CUP, DISLOCATION, AND ELEVATED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE LOOSENING OF ACETABULAR COMPONENT, SOFT TISSUE LOSS, METALLOSIS, AND DISLOCATION. OPERATIVE NOTE REPORTED OF MASSIVE SOFT TISSUE DESTRUCTION AND BROKEN 2 SCREWS. THERE WAS NO LOT NUMBER PROVIDED FOR THE BROKEN SCREWS. DOI: (B)(6) 2012. DOR: (B)(6) 2016, (RIGHT HIP) FOURTH REVISION.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Necrosis; No Code Available; Tissue Damage

  MAUDE report 9173200 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION. DOI: (B)(6) 2011 (HEAD AND LINER); DOR: (B)(6) 2012 (LEFT HIP); DOI: (B)(6) 2008 (CUP, SCREWS, STEM, AND SLEEVE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9163216 ↗
• InjuryMay 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES LOOSENIG OF CUP AND BONE FRACTURE. DOI: (B)(6) 2007, DOR: (B)(6) 2009, (LEFT HIP) FIRST REVISION.

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8611399 ↗
• InjuryMay 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES LOOSENIG OF CUP AND BONE FRACTURE. DOI: (B)(6) 2007, DOR: (B)(6) 2009, (LEFT HIP) FIRST REVISION.

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8611392 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, 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 8544036 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 8543934 ↗
• 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 8486607 ↗
• 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 8486604 ↗
• InjuryJan 29, 2019Osseointegration Problem; Osseointegration Problem

  (B)(4). REASON FOR ORIGINAL COMPLAINT: LITIGATION PAPERS ALLEGE THE FOLLOWING: ON OR ABOUT (B)(6) 2008, PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY PROCEDURE. DURING THE (B)(6) 2008 PROCEDURE, A PINNACLE DEVICE WITH A POLYETHYLENE LINER WAS IMPLANTED. FOLLOWING THE PROCEDURE PATIENT SUFFERED THREE DISLOCATIONS IN RAPID SUCCESSION WITHIN LESS THAN A MONTH. AS A RESULT, ON (B)(6) 2008, PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY REVISION. TO DATE FOLLOWING THE (B)(6) 2008 PROCEDURE, PATIENT STILL SUFFERS A GREAT DEAL OF PAIN AND DISCOMFORT IN HIS LEFT HIP. HE CAN AMBULATE ONLY SHORT DISTANCES AND REQUIRES A WHEELCHAIR. UPDATE 12/20/12: PFS WAS RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOB AND WEIGHT ADDED. UPDATE AD 04 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND FRACTURE OF COMPONENT. ADDED CUP AND SCREWS DUE TO LOOSENING OF CUP. ADDED UNKNOWN IMPLANT TO ADDRESS FRACTURE, LAW FIRM AND REVISION HOSPITAL. UPDATED PATIENT NAME AND PRODUCT DETAILS OF UNKNOWN HEAD AND LINER. DOI: (B)(6) 2008;

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

  MAUDE report 8284532 ↗
• InjuryDec 19, 2018Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  THE PATIENT WAS REVISED BECAUSE OF INSTABILITY. THE CUP HAD MIGRATED TO A VERTICAL POSITION AND ONE SCREW HAD BROKE. THE PATIENT BEGAN TO NOTICE PAIN AND SORENESS IN HIS HIP AREA. UPDATE 10/22/12- PFS REPORTED PAIN SORENESS AND INCREASED METAL IONS. UPDATE AD 3 MAY 2018: RECEIPT OF PPF AND IMPLANT RECORDS. PPF ALLEGED ELEVATED METAL IONS AFTER THE FIRST REVISION.

  Patient problems: No Code Available; Pain

  MAUDE report 8179340 ↗
• InjuryNov 14, 2018Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  PATIENT ALLEGES PAIN, DISCOMFORT, INFLAMMATION, POPPING AND SNAPPING AND ELEVATED METAL ION LEVELS, PSEUDOTUMOR, LOOSENING OF CUP, METAL WEAR METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8070815 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENDING PRODUCT LIABILITY, CUSTOMER ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7920399 ↗
• 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

  Patient problems: Pain

  MAUDE report 7788342 ↗
• InjuryJul 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP COMPONENT AT BONE TO IMPLANT INTERFACE. REMOVED CUP AND LINER AND IMPLANTED NEW CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7673308 ↗
• InjuryJun 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE CUP MOVED BUT WAS NOT LOOSE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7568852 ↗
• InjuryApr 13, 2018Loss of Osseointegration; Loss of Osseointegration

  DER STATES THAT THE CUP WAS IN POOR POSITIONING AND LOOSE AT BONE TO IMPLANT INTERFACE. THE SURGEON REMOVED CUP AND SCREWS AND REPLACED WITH A LARGER PINNACLE REVISION CUP. STEM AND FEMORAL BALL ARE COMPETITOR. DOI: (B)(6) 2012; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7428709 ↗