SOLUTION SYSTEM 1257-45-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295019909), received between Apr 13, 2018 and Aug 20, 2024 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT'S PINNACLE REVISION CUP AND CONSTRAINED LINER PARTIALLY PULLED OUT OF THE ACETABULUM. THE SURGEON REMOVED THE CONSTRAINED LINER, ACETABULAR CUP AND FIVE SCREWS. A NEW REVISION CUP AND DUAL MOBILITY LINER WERE PLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20002007 ↗
• 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 15699581 ↗
• 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 15324602 ↗
• MalfunctionAug 27, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE 5.0 NON-LOCKING SCREW WAS USED IN A 54/56 X20 MM GRIPTION TF AUGMENT TO COMPRESS BUT WAS ABLE TO PASS ALMOST COMPLETELY THROUGH THE FLAT (OUTER) PORTION OF THE AUGMENT. 5.5 LOCKERS WERE USED IN ADDITION TO BONE CEMENT FOR A STABLE CONSTRUCT. IT WAS ALSO INDICATED THAT THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377133 ↗
• InjuryApr 21, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED AS ACETABULAR SHELL IMPLANT LOOSENING/MOVEMENT. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11704523 ↗
• 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 11521270 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM DIAGNOSED THE END OF (B)(6). 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; Pulmonary Embolism; Thrombosis

  MAUDE report 10072785 ↗
• 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 (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 WELL IN GROWN

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10072340 ↗
• 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 9909113 ↗
• 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 9519413 ↗
• 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 9519403 ↗
• InjuryJan 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN. LITIGATION ALLEGES DISCOMFORT AND DIFFICULTY AMBULATING. UPDATE AD 14 MAY 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; No Code Available; Pain; Tissue Damage

  MAUDE report 8230828 ↗
• InjuryJan 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN. LITIGATION ALLEGES DISCOMFORT AND DIFFICULTY AMBULATING. UPDATE AD 14 MAY 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

  MAUDE report 8230822 ↗
• 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 8070696 ↗
• 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 8070648 ↗
• 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 7786688 ↗
• 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 7428732 ↗