Restoration 2080-0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327037173), received between Aug 20, 2019 and Dec 2, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE POST-REVISION OF THE PATIENT'S ACETABULAR SHELL. REP MADE AWARE ON 09/NOVEMBER/2021. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF PI CREATION. AS REPORTED: "IT WAS REPORTED THAT A LEFT TOTAL HIP REPLACEMENT HAD A LOOSE ACETABULAR COMPONENT DONE FROM A PRIOR SURGERY, DATE UNKNOWN. UPON REVIEWING THE X RAYS IT WAS APPARENT THE CUP WAS LOOSE AND DISPLACED. DR. REQUESTED A REVISION CUP, MDM LINER, INSERT AND HEAD. HE ALSO REQUESTED A NEW RESTORATION MODULAR BODY DUE TO THE PRE SURGERY IDENTIFICATION. THE PROCEDURE WAS PERFORMED THROUGH A POSTERIOR APPROACH. THE OLD CUP WAS REMOVED. THE NEW BODY, CUP LINER AND HEAD WERE IMPLANTED PER SURGICAL TECHNIQUE AS WELL AS 7 SCREWS INTO THE ACETABULUM. THE PATIENT APPEARED TO HAVE SATISFACTORY STABILITY AND LEG LENGTH PER DR. AN INTRA OPERATIVE X RAY WAS TAKEN TO CONFIRM THE PLACEMENT. SATISFIED DR CLOSED UP THE PROCEDURE. I WAS INFORMED YESTERDAY (B)(6) 2021 THAT THE NEW IMPLANTS HAVE AGAIN BECOME LOOSE AND DISLODGED FROM THE ACETABULUM. DR. IS NOW IN THE PLANNING STAGES FOR A FOLLOW UP PROCEDURE." SPOKE TO REP, WHO PROVIDED THE USAGE SHEET FROM THE REVISION ON (B)(6) 2021. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE

  Patient problems: Inadequate Osseointegration

  MAUDE report 12916791 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE POST-REVISION OF THE PATIENT'S ACETABULAR SHELL. REP MADE AWARE ON (B)(6) 2021. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF PI CREATION.. AS REPORTED: "IT WAS REPORTED THAT A LEFT TOTAL HIP REPLACEMENT HAD A LOOSE ACETABULAR COMPONENT DONE FROM A PRIOR SURGERY, DATE UNKNOWN. UPON REVIEWING THE X RAYS IT WAS APPARENT THE CUP WAS LOOSE AND DISPLACED. DR REQUESTED A REVISION CUP, MDM LINER, INSERT AND HEAD. HE ALSO REQUESTED A NEW RESTORATION MODULAR BODY DUE TO THE PRE SURGERY IDENTIFICATION. THE PROCEDURE WAS PERFORMED THROUGH A POSTERIOR APPROACH. THE OLD CUP WAS REMOVED. THE NEW BODY, CUP LINER AND HEAD WERE IMPLANTED PER SURGICAL TECHNIQUE AS WELL AS 7 SCREWS INTO THE ACETABULUM. THE PATIENT APPEARED TO HAVE SATISFACTORY STABILITY AND LEG LENGTH PER DR. AN INTRA OPERATIVE X RAY WAS TAKEN TO CONFIRM THE PLACEMENT. SATISFIED DR CLOSED UP THE PROCEDURE. I WAS INFORMED YESTERDAY (B)(6) 2021 THAT THE NEW IMPLANTS HAVE AGAIN BECOME LOOSE AND DISLODGED FROM THE ACETABULUM. DR IS NOW IN THE PLANNING STAGES FOR A FOLLOW UP PROCEDURE." SPOKE TO REP, WHO PROVIDED THE USAGE SHEET FROM THE REVISION ON (B)(6) 2021. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISE

  Patient problems: Inadequate Osseointegration

  MAUDE report 12916656 ↗
• InjuryAug 20, 2019Break; Break

  A 60MM TRITANIUM CUP REQUIRED REVISION FOR LOOSENING. THE SURGEON BELIEVED IT WAS NOT THE FAULT OF THE PROSTHESIS. 2ND REVISION OF ORIGINAL COMPETITOR CUP UPDATE: "THE SCREWS WERE ACCIDENTALLY DISCARDED AT LEAST ONE WAS BROKEN AS WELL."

  Patient problems: Injury

  MAUDE report 8910730 ↗