NA 1011-85-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295000655), received between Jun 10, 2019 and Oct 6, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2021Fracture; Migration; Fracture; 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 12583358 ↗
• MalfunctionJul 22, 2021Fracture; Fracture

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILURE OF THE PROTRUSIO CAGE WITH ACETABULAR FRACTURE : MIGRATION/LOOSENING - POLYETHYLENE SHELL -- INFERIOR TANG OF CAGE HAS FRACTURED AND SEPARATED, SUPERIOR TANG IS INTACT. THE POSTERIOR PLACE HAS ALSO FRACTURED. GREATER TROCH IS BUTTED UP AGAINST THE PELVIC ILIAC WING, HIP ITSELF IS LOCATED EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION: (B)(6) 2019 (CUP, LINER, FEMORAL HEAD, TO ADDRESS A PELVIC BONE FRACTURE). DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT HIP). (B)(6) 2021 MEDICAL RECORDS NOTE THE PATIENT IS 2 YEARS OUT FROM REVISION SURGERY FOR HER PROTRUSION AND BOTH COLUMN ACETABULAR FRACTURE. THE PATIENT HAS A FAILED CAGE, IT MIGRATED INTO THE PELVIS. THE PATIENT CONTINUES TO HAVE A NONUNION OF HER BI-COLUMN FRACTURE AND FAILURE OF HER CAGE. AT THIS TIME THERE WAS NO INVASIVE TREATMENT.

  Patient problems: Pain

  MAUDE report 12215322 ↗
• 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 8682448 ↗