REFLECTION 71332540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010463296), received between Oct 2, 2018 and Nov 21, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K211176, K990666); they may or may not involve this specific model.

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.

• InjuryNov 21, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR THE THIRD TIME. ASEPTIC LOOSENING. HIP PREPPED AND DRAPED, JOINTLY OPENED, SPECIMENS TAKEN. JOINT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD REMOVED, POLY LINER AND CUP AND SCREWS REMOVED. EXISTING SOCKET REAMED TO A BLEEDING BONE BED. IMPLANT TRIALED, JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE. DEFINITIVE ACETABULAR IMPLANT INSERTED WITH BONE CEMENT. TRIPOLAR LINER/HEAD TRIALED VIA REDUCTION, HIP STABLE, DEFINITIVE TRIPOLAR IMPLANTS INSERTED AND HIP REDUCED, HIP CLOSED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9353653 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. STEM, HEAD AND ACETABULAR LINER REMOVED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8276369 ↗
• InjuryOct 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CPCS R3 REVISED FOR DISLOCATION. HIP STABLE ON TABLE. IMPINGE ANTERIOR ACETABULAR OSTEOPHYTE. HEAD STEM LINER & SCREWS REMOVED. POLAR CUP CEMENTED INTO SHELL. SMALLER STEM CEMENTED. POLAR ARTICULATION STABLE. NIL IMPLANTS FOR RETRIEVAL.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7928812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K990666. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-2297-2016 · Jul 6, 2016 · Terminated
  SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revis