REFLECTION 71332535Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010463289), received between Dec 11, 2017 and May 31, 2022 — classified as 4 injuries, 1 malfunction.

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, 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. 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.

• MalfunctionMay 31, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON STRIPPED A REFLECTION SPHERICAL HEAD SCREW 35MM ((B)(4)), THIS OCCURRED WHILE USING INSTRUMENTS INSIDE THE PATIENT. THE STRIPPED SCREW WAS LEFT IMPLANTED IN THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH AND NEPHEW BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549731 ↗
• InjuryAug 17, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT COMPLAINING OF A PAINFUL CLUNK WHEN INTERNALLY AND EXTERNALLY ROTATING LEG IN FLEXION. SURGEON BELIEVES CUP NOT MEDIALISED ENOUGH, IS PROUD AND A SCREW IS PERHAPS IRRITATING SOFT TISSUE. THE CUP ALSO RETROVERTED. REVISION SURGERY. - RANGE OF MOTION WAS TESTED WHILE PATIENT ASLEEP AND SURGEON REPORTED STABLE -THROUGH ORIGINAL INCISION -OPENED JOINT TO VIEW IMPLANTS. - SURGEON FELT ONCE OPEN THAT JOINT WAS DISLOCATING TOO EARLY WITH FLEXION AND INTERNAL ROTATION. HEAD REMOVED, LINER REMOVED, TWO SCREWS REMOVED AND THE CUP EXPLANTED. SURGEON REAMED DEEPER WITH A 58MM REAMER, TRIALLED A 58MM AND THEN INSERTED A 58MM THREE HOLE R3 CUP. A 40MM LATERALISED LINER 20 DEGREE HOOD WAS INSERTED AFTER TRIALLING AND 40MM PLUS 8MM HEAD INSERTED. SURGEON FELT THAT THIS COMBINATION GAVE BEST RANGE OF MOTION AND STABILITY.

  Patient problems: Pain

  MAUDE report 7795177 ↗
• InjuryFeb 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT POSITIONED AND HIP DISLOCATED. LINER AND SCREWS REMOVED CUP WAS LOOSE. REMOVED CUP REAMED ACETABULUM AND IMPLANTED A 52MM MULTIHOLE CUP AND THREE SCREWS. A CONSTRAINED LINER INSERTED AND CHECKED TO BE LOCKED IN THE CUP. HIP REDUCED USING A 22MM STRYKER HEAD. HIP STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 7262493 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 7140050 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE PARTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7105142 ↗

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