Restoration 504-02-66F-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327012491), received between Jan 3, 2019 and Dec 2, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Packaging 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 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 RE

  Patient problems: Inadequate Osseointegration

  MAUDE report 12916787 ↗
• MalfunctionJun 27, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled

  UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANTS WERE LOOSE IN PACKAGING. THE IMPLANTS HAVE BEEN SHIPPED TO THE DECON LAB. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8739104 ↗
• MalfunctionJun 26, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled

  UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANT WAS LOOSE IN PACKAGING. IMPLANTS HAVE BEEN SHIPPED TO THE DECON LAB. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8734524 ↗
• MalfunctionJan 3, 2019Packaging Problem; Packaging Problem

  AS REPORTED: "UPON OPENING THE IMPLANT LISTED ABOVE IT WAS OBSERVED THAT THE IMPLANT WAS LOOSE IN THE INNER PACKAGING AND HAD RUBBED AGAINST THE INNER PLASTIC WALLS CREATING PLASTIC DEBRIS THAT WAS ADHERED TO THE POROUS SURFACE OF THE IMPLANT. THE IMPLANT WAS LAVAGED THOROUGHLY AND IMPLANTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214795 ↗