Restoration 2080-0040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327037135), received between Oct 3, 2018 and Dec 2, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 (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 12916834 ↗
• InjuryJan 24, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  PATIENT SLIPPED AND FELL. THE PATIENT SUSTAINED A FURTHER FRACTURED PELVIS AND RESULTED IN THE PATIENT REQUIRING ADDITIONAL SURGERY. THIS WAS TO REVISE THE PLATE AND CUP IN THE RIGHT HIP REPLACEMENT. THE IMPLANTS THAT HAD FORMED THE INITIAL PI 2019030 WERE EXPLANTED. THE 1/3RD TUBULAR PLATE THAT WAS INITIALLY IMPLANTED FOR THE POSTERIOR COLUMN FRACTURE WAS REVISED AND A MATTA PELVIC PLATE APPLIED. THE CUP WAS REMOVED ALONG WITH THE SCREWS. THE SHAFT OF THE 40MM GAP CUP SCREW ( ITEM 20800040 LOT PW17H7) WAS BROKEN WITH THE FALL. SCREW HEAD AND PART OF THE SHAFT CAME OUT; THE DISTAL PART OF THE SHAFT DR ELLIS ELECTED TO LEAVE IN SITU. THE FRACTURE OF THE SUPERIOR PELVIC RAMUS; THAT HAD BEEN OBSERVED DURING REVIEW OF THE POST-OP X-RAYS FROM THE INITIAL REVISION ON 18TH OF FEBRUARY WAS STILL VISIBLE. THE T-MARS (ZIMMER) REVISION CUP THAT WAS PUT IN TODAY, HAD A SCREW HOLE; WHICH WENT ALONG THE TRAJECTORY OF THE SUPERIOR PUBIC RAMUS. NO FURTHER FIXATION WAS APPLIED TO THIS FRACTURE; NO FURTHER PLATES OR SCREWS. NO FURTHER MEDICAL RECORDS ARE AVAILABLE DUE TO CONFIDENTIALITY. THE EXPLANTED IMPLANTS WERE DISCARDED BY THE NURSING STAFF AND UNABLE TO BE RETRIEVED.

  Patient problems: Hip Fracture; Injury

  MAUDE report 9626676 ↗
• InjuryOct 3, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A 58MM HEMISPHERICAL SHELL, 4 SCREWS, AND A 40F POLY LINER WERE REVISED TO A 62MM HEMISPHERICAL SHELL WITH 5 SCREWS AND A 40G POLY LINER. THE HEAD AND STEM WERE AND REMAIN COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7930457 ↗