Restoration 2080-0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327037104), received between Oct 3, 2018 and Dec 2, 2021 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 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 (B)(6) 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 (B)(6) 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 (B)(6) HAVE AGAIN BECOME LOOSE AND DISLODGED FROM THE (B)(6). 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 REVISED LI

  Patient problems: Inadequate Osseointegration

  MAUDE report 12916839 ↗
• MalfunctionNov 4, 2021Fracture; Fracture

  AS REPORTED: "RIGHT REVISION TOTAL HIP ARTHROPLASTY. ACETABULAR COMPONENT, POSSIBLE FEMORAL COMPONENT. ALL ACETABULAR COMPONENTS WERE REMOVED. OBSERVATION: 4 BROKEN SCREWS REMOVED AND CUP WAS LOOSE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."

  Patient problems: Inadequate Osseointegration

  MAUDE report 12750871 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PELVIC DISCONTINUITY. INTRA-OPERATIVELY, A SMALL POCKET OF BLACK TISSUE WAS FOUND. THE SURGEON IS UNSURE OF WHERE THE BLACK TISSUE CAME FROM AS THE PATIENT DID NOT HAVE ANY COCR DEVICES SINCE A 2018 REVISION (PI (B)(4)). THE 64 G TRIDENT HEMISPHERICAL SHELL WITH 5 SCREWS, 44G LINER, AND 44MM BIOLOX HEAD WITH +4 SLEEVE WERE REVISED (THERE ARE NO ALLEGATIONS AGAINST THE LINER OR HEAD). UPDATED ON 20-NOV-2019 BY SR BASED ON MEDICAL REVIEW OSTEOLYSIS IS EVIDENT AROUND THE TRIDENT SHELL. LOOSE CUP WITH PELVIC SEPARATION IS REPORTED.

  Patient problems: Hip Fracture; Injury; Osteolysis

  MAUDE report 9513174 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PELVIC DISCONTINUITY. INTRA-OPERATIVELY, A SMALL POCKET OF BLACK TISSUE WAS FOUND. THE SURGEON IS UNSURE OF WHERE THE BLACK TISSUE CAME FROM AS THE PATIENT DID NOT HAVE ANY COCR DEVICES SINCE A 2018 REVISION ((B)(4)). THE 64 G TRIDENT HEMISPHERICAL SHELL WITH 5 SCREWS, 44G LINER, AND 44MM BIOLOX HEAD WITH +4 SLEEVE WERE REVISED (THERE ARE NO ALLEGATIONS AGAINST THE LINER OR HEAD). UPDATED ON 20-NOV-2019 BY SR BASED ON MEDICAL REVIEW. OSTEOLYSIS IS EVIDENT AROUND THE TRIDENT SHELL. LOOSE CUP WITH PELVIC SEPARATION IS REPORTED.

  Patient problems: Hip Fracture; Injury; Osteolysis

  MAUDE report 9513166 ↗
• 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 8911067 ↗
• 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 7930379 ↗