Citation 6265-5115Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613153074380), received between Dec 10, 2018 and Feb 14, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2020Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  AS REPORTED: "REMOVED STEM, LINER AND HEAD FROM PATIENT REPLACING WITH STRYKER RESTORATION STEM/ CONE BODY, CABLES AND MDM IMPLANTS. NO OTHER AND NO MORE INFORMATION AVAILABLE FROM HOSPITAL." REP CONFIRMED THAT THE FEMORAL HEAD DISASSOCIATED FROM THE STEM.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Injury

  MAUDE report 9711670 ↗
• InjuryNov 8, 2019Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED. PRE-REVISION PATIENT COMPLAINT INCLUDED HEARING A POPPING SOUND. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: TRUNNION WEAR, TRUNNION BROKE OFF THE STEM, GRAYISH BLACK TISSUE, WEAR OF THE LINERS RIM DUE TO IMPINGEMENT OF THE STEM ON THE LINER. THE SHELL HAD NO ALLEGATIONS AGAINST IT AND WAS NOT REVISED. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD AND NEW LINER. REP PROVIDED INTRA- OP PHOTOS AND AN EXPLANT PICTURE AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9295774 ↗
• InjuryOct 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS AT HIS ACCOUNT AND CROSSED HIS LEGS AND HEAD DISASSOCIATED FROM STEM. UPDATE (B)(6) 2019 WG: SPOKE TO REP. A RIGHT HIP X-RAY FROM (B)(6) 2019, USAGE SHEET, AND EXPLANT PICTURE WERE PROVIDED. REP CONFIRMED NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9177138 ↗
• MalfunctionDec 11, 2018Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  BROACH SAT FLUSH WITH NECK RESECTION AND THE STEM SAT PROUD BY AT LEAST 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8152523 ↗
• MalfunctionDec 10, 2018Positioning Problem; Positioning Problem

  THE CITATION BROACH SAT COUNTER SUNK FROM THE NECK RESECTION AND THE REAL IMPLANT SAT PROUD BY AT LEAST 4MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148137 ↗