NA 1011-40-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295000433), received between Dec 1, 2018 and Oct 6, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2021Migration; Migration

  CLINICAL RECORDS, FROM CLINICAL VISITS ON (B)(6) 2021 AND ON (B)(6) 2021, REPORTED THAT THE PATIENT HAD A FAILED TOTAL HIP WITH A PROTRUSIO CAGE PELVIC CONSTRUCT, WITH THE CAGE HAVING FRACTURED PARTIALLY AND MIGRATED INTO THE PELVIC CAVITY. X-RAYS DEMONSTRATED THIS. THE PATIENT WAS EXPERIENCING ONLY MINOR PAIN AND DISCOMFORT, AND SOME SCIATICA, DESPITE THIS, AND WAS AMBULATORY AND CAPABLE OF MODIFIED ACTIVITIES OF DAILY LIVING USING APPLIANCES. THE SURGEON INDICATED THAT THE PROGRESSION OF THE CAGE'S FAILURE MIGHT HAVE REACHED AN ENDPOINT, AS THE PATIENT'S TROCHANTER WAS NOW IMPINGING ON THE PELVIC WING, PREVENTING THE FEMORAL HEAD FROM ENCROACHING INTO THE PELVIS ANY FURTHER. AS A CONSEQUENCE, THE PATIENT'S LEG WAS SHORTENED. A CT SCAN HAD BEEN ORDERED TO BE CERTAIN THAT THE CAGE WAS NOT THREATENING ANY MAJOR PELVIC BLOOD VESSELS. THE PLAN AT PRESENT IS TO HOLD OFF ON DOING ANY SURGICAL INTERVENTION, AS THIS IS CONSIDERED A VERY HIGH RISK SURGERY DUE TO THE APPROACH REQUIRING INVOLVEMENT WITH INTRAPELVIC TISSUES, VESSELS, AND ORGANS.

  Patient problems: Discomfort; Insufficient Information; Joint Laxity; Pain; Physical Asymmetry

  MAUDE report 12583359 ↗
• InjuryOct 6, 2021Migration; Migration

  CLINICAL RECORDS, FROM CLINICAL VISITS ON (B)(6) 2021 AND ON (B)(6) 2021, REPORTED THAT THE PATIENT HAD A FAILED TOTAL HIP WITH A PROTRUSIO CAGE PELVIC CONSTRUCT, WITH THE CAGE HAVING FRACTURED PARTIALLY AND MIGRATED INTO THE PELVIC CAVITY. X-RAYS DEMONSTRATED THIS. THE PATIENT WAS EXPERIENCING ONLY MINOR PAIN AND DISCOMFORT, AND SOME SCIATICA, DESPITE THIS, AND WAS AMBULATORY AND CAPABLE OF MODIFIED ACTIVITIES OF DAILY LIVING USING APPLIANCES. THE SURGEON INDICATED THAT THE PROGRESSION OF THE CAGE'S FAILURE MIGHT HAVE REACHED AN ENDPOINT, AS THE PATIENT'S TROCHANTER WAS NOW IMPINGING ON THE PELVIC WING, PREVENTING THE FEMORAL HEAD FROM ENCROACHING INTO THE PELVIS ANY FURTHER. AS A CONSEQUENCE, THE PATIENT'S LEG WAS SHORTENED. A CT SCAN HAD BEEN ORDERED TO BE CERTAIN THAT THE CAGE WAS NOT THREATENING ANY MAJOR PELVIC BLOOD VESSELS. THE PLAN AT PRESENT IS TO HOLD OFF ON DOING ANY SURGICAL INTERVENTION, AS THIS IS CONSIDERED A VERY HIGH RISK SURGERY DUE TO THE APPROACH REQUIRING INVOLVEMENT WITH INTRAPELVIC TISSUES, VESSELS, AND ORGANS.

  Patient problems: Discomfort; Insufficient Information; Joint Laxity; Pain; Physical Asymmetry

  MAUDE report 12583350 ↗
• InjuryMar 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT BROKE THE PROTRUSIO CAGE AND A FEW SCREWS IMPLANTED BACK IN 2019. SURGEON REMOVED ALL CAGE AND SCREWS ALONG WITH A CEMENTED CUP AND REPLACED WITH A PINNACLE REVISION CUP AND USED DUAL MOBILITY TO HELP PATIENT WITH STABILITY. NO SURGICAL DELAY. DOI:(B)(6) 2019, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11436238 ↗
• InjuryFeb 26, 2020Osseointegration Problem; Unintended Movement; Osseointegration Problem; Unintended Movement

  PPF AND STICKER SHEETS RECEIVED. THERE WERE NO ALLEGATIONS REPORTED HOWEVER THE PATIENT WAS REVISED AND THE REASON FOR REVISION WAS NOT PROVIDED. DOI: (B)(6) 2017 - DOR: (B)(6) 2018 (LEFT HIP, FIFTH REVISION).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 9753107 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO OPERATING ROOM FOR REMOVAL OF HARDWARE DUE TO INFECTION AND ONE STAGE REVISION WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9185890 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DVTS BILATERALLY: VASCULAR - DVT EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019 (PELVIC FRACTURE: CUP, LINER, AND HEAD REVISED); DOE: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Thrombosis

  MAUDE report 8682456 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DVTS BILATERALLY: VASCULAR - DVT EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019 (PELVIC FRACTURE: CUP, LINER, AND HEAD REVISED); DOE: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Thrombosis

  MAUDE report 8682452 ↗
• InjuryFeb 19, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT HE PROTRUSIO CAGE BROKE AND WAS REMOVED. DUE TO SIGNIFICANT BONE LOSS, ALL COMPONENTS WERE REMOVED AND GIRDLE STONE WAS PERFORMED. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING AT BONE TO IMPLANT INTERFACE BUT IT WAS NOT INDICATED WHICH COMPONENT WAS LOOSE. DOI: (B)(6) 2016; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 8351239 ↗
• InjuryFeb 19, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT HE PROTRUSIO CAGE BROKE AND WAS REMOVED. DUE TO SIGNIFICANT BONE LOSS, ALL COMPONENTS WERE REMOVED AND GIRDLE STONE WAS PERFORMED. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING AT BONE TO IMPLANT INTERFACE BUT IT WAS NOT INDICATED WHICH COMPONENT WAS LOOSE. DOI: (B)(6) 2016. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 8351232 ↗
• InjuryFeb 19, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT HE PROTRUSIO CAGE BROKE AND WAS REMOVED. DUE TO SIGNIFICANT BONE LOSS, ALL COMPONENTS WERE REMOVED AND GIRDLE STONE WAS PERFORMED. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING AT BONE TO IMPLANT INTERFACE BUT IT WAS NOT INDICATED WHICH COMPONENT WAS LOOSE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 8351225 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES INFECTION, DISLOCATION, MUSCLE DAMAGE AND ANEMIA. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY,PATIENT WAS REVISED TO ADDRESS DISLOCATION,STATUS POST COMPLEX RIGHT REVISION. REVISION NOTES REPORTED OF ANTERIOR DISLOCATION. CLINICAL NOTES REPORTED OF STAPH INFECTION AND PURULENT DRAINAGE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8239674 ↗
• InjuryDec 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM.

  Patient problems: Pulmonary Embolism

  MAUDE report 8123954 ↗
• InjuryDec 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM.

  Patient problems: Pulmonary Embolism

  MAUDE report 8121999 ↗