NA 1011-40-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295000440), received between Dec 1, 2018 and Oct 6, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 12583360 ↗
• 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 12583349 ↗
• InjuryJul 23, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT PRESENTED TO DOCTOR'S OFFICE WITH PAIN. XRAYS SHOWED POSSIBLE LOOSENING OF PROTRUSIO CAGE. SURGERY SCHEDULED AND DR. (B)(6) FOUND CAGE LOOSE . REMOVED HEAD, LINER AND CAGE AND REINSERT A MULTI HOLE GRIP CUP, LINER AND HEAD. DOI: (B)(6) 2017, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10312304 ↗
• 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 9753110 ↗
• 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 9753104 ↗
• 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 9753100 ↗
• 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 9185858 ↗
• 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 8682455 ↗
• 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 8682453 ↗
• 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 8351230 ↗
• 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 8239856 ↗
• 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 8123944 ↗
• 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 8121987 ↗