NA 1011-40-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295000464), received between Nov 7, 2018 and Jul 23, 2020 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 10312313 ↗
• 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 10312233 ↗
• 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 10312228 ↗
• 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 9753114 ↗
• 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 9753109 ↗
• 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 9185870 ↗
• 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 8239645 ↗
• 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 8121998 ↗
• 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 8121870 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8056496 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8047813 ↗