REFLECTION 71336054Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010197559), received between Oct 20, 2017 and Feb 26, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K211176, K960094); 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 16, 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.

• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TOTAL HIP INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8370075 ↗
• InjuryFeb 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  A REVISION SURGERY WAS PERFORMED DUE TO THERE IS BONE LOSS AROUND PROXIMAL STEM AND CUP DUE TO SOME TYPE OF ACETABULAR LOOSENING, PAIN RADIATING INTO HIP AND GROIN AS MAIN SYMPTOMS. SURGEON OPENED THE JOINT VIA PREVIOUS INCISION, INSPECTED STEM AND CUP AND REMOVED HEAD. STEM WAS WELL FIXED. LINER WAS REMOVED USING APPROPRIATE TOOL. SCREWS REMOVED VIA ARTICULATING SCREWDRIVER. CUP WAS REMOVED VIA ZIMMER EXPLANT SURGEON REAMED TO 55MM AND INSERTED A 51MM POLAR CUP CEMENTED. AN APPROPRIATE 28MM PLUS ZERO HEAD TRAILED AND HIP WAS STABLE. LINER AND HEAD WERE INSERTED AS PER TECHNIQUE. SURGEON FELT HIP WAS STABLE. A ZIMMER GRIP PLATE WAS ALSO USED.

  Patient problems: Injury

  MAUDE report 8307730 ↗
• InjuryOct 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DEBRIDEMENT WAS PERFORMED DUE TO INFECTION. THE PATIENT HAD PAIN. THE PRODUCTS ARE STILL IMPLANTED. THERE IS NO PRODUCT FAILURE OR NO LOOSENING.

  Patient problems: Injury

  MAUDE report 6965504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K960094. 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-1066-2014 · Jan 23, 2014 · Terminated
  Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rh