Wagner SL Revision® 01.00102.217Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024485228), received between Sep 21, 2020 and May 26, 2026 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Biocompatibility; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO HAVING PAIN AND DIFFICULTY AMBULATING. SUBSEQUENTLY, THE PATIENT CONTINUED TO EXPERIENCE PAIN, DIFFICULTY AMBULATING, SWELLING, AND IMPAIRED HEALING. THE PATIENT ALLEGES LEG LENGTH DISCREPANCY AND A SYSTEMIC ALLERGIC REACTION TO THE IMPLANT COATING. ADDITIONALLY, THE PATIENT ALLEGES THAT THE POSTERIOR SCREW OF THE CUP IS MIGRATING AND PENETRATING THE GLUTEN MUSCLES AND CAUSING FEMORAL AND SCIATIC NERVE DAMAGE AND NEUROPATHY. NO MEDICAL RECORDS HAVE BEEN PROVIDED THUS FAR. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Fever; Hypersensitivity/Allergic reaction; Impaired Healing; Itching Sensation; Loss of Range of Motion; Nerve Damage; Pain; Skin Discoloration; Swelling/ Edema; Unequal Limb Length

  MAUDE report 25278455 ↗
• InjuryOct 24, 2024Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Failure of Implant; Osteolysis

  MAUDE report 20529934 ↗
• InjuryApr 22, 2021Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT A REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND IMPLANT FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11705522 ↗
• InjuryFeb 9, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Failure of Implant; Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 11300139 ↗
• MalfunctionJan 15, 2021Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176659 ↗
• InjurySep 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10559932 ↗