Restoration 2080-0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327037098), received between Apr 29, 2019 and Nov 4, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 12750826 ↗
• 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 12750825 ↗
• 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 12750766 ↗
• 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 2161928). 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 9513248 ↗
• InjuryApr 29, 2019Osseointegration Problem; Osseointegration Problem

  ITS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE PATIENTS RIGHT HIP HAD TO BE REVISED ON (B)(6) 2018 DUE TO ACETABULAR COMPONENT LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8561413 ↗
• InjuryApr 29, 2019Osseointegration Problem; Osseointegration Problem

  ITS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE PATIENTS RIGHT HIP HAD TO BE REVISED ON (B)(6) 2018 DUE TO ACETABULAR COMPONENT LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8561411 ↗
• InjuryApr 29, 2019Osseointegration Problem; Osseointegration Problem

  IT'S REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE PATIENTS RIGHT HIP HAD TO BE REVISED ON (B)(6) 2018 DUE TO ACETABULAR COMPONENT LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8561318 ↗