REFLECTION 71333336Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010455697), received between Oct 18, 2017 and Dec 28, 2021 — classified as 3 injuries, 5 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K002747, K211176); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REF XLPE 32 20 DEG 58-60 G COULD NOT BE INSTALLED WITH A REF THREE HOLE SHELL 58MM, ALTHOUGH IT WAS TRIED FOR AN HOUR IN VARIOUS DIRECTIONS. SURGERY WAS COMPLETED, AFTER A DELAY OF AN HOUR, WITH A S+N BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095834 ↗
• MalfunctionJun 17, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR SURGERY, A REFLECTION XLPE 32 20 DEGREES 58-60 G COULD NOT BE IMPLANTED. SURGERY WAS COMPLETED USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED, YET A DELAY GREATER THAT 30 MINS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020935 ↗
• MalfunctionJan 24, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A THR, THE REFLECTION XLPE 32 20 DEGREES 58-60 G COULD NOT BE IMPLANTED IN PLACE. SEVERAL ATTEMPTS WERE MADE, BUT IT STILL DID NOT WORK. FINALLY, A BACKUP DEVICE WAS USED TO FINISH THE SURGERY. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221230 ↗
• InjuryOct 23, 2020Difficult to Insert; Fitting Problem; Difficult to Insert; Fitting Problem

  IT WAS REPORTED THAT DURING A THA SURGERY, THE LINER COULD NOT BE PLACED SMOOTHLY AFTER THE SURGEON IMPLANTED THE REFLECTION ACETABULAR SYSTEM. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO HARM OR INJURY REPORTED ON PATIENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10730613 ↗
• MalfunctionJun 10, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A THR PROCEDURE, AFTER INSTALLING THE REFLECTION XLPE 58MM-60MM LINER DURING THE SURGERY, IT WAS FOUND THAT THE LINER COULD NOT BE LOCKED WITH THE OUTER CUP. AFTER TRYING FOR 20 MINUTES, ANOTHER LINER OF THE SAME SIZE WAS OPENED, AND FINALLY THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT RESULTED IN A TOTAL DELAY OF NEARLY 30 MINUTES, WHICH INCREASED THE RISK OF BLEEDING IN SURGERY, NEVERTHELESS, NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10139547 ↗
• InjuryOct 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY, PERFORMED DUE TO DISLOCATION OF HIP 3 TIMES. LINER AND HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 9164265 ↗
• 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 7105144 ↗
• MalfunctionOct 18, 2017Loose or Intermittent Connection

  DURING THE SURGERY AFTER ACETABULAR CUP WAS IMPLANTED, THE LINER WOULD NOT MATCH TIGHTLY WITH THE CUP. FINALLY THE SURGEON TOOK USED BACKUP DEVICE TO COMPLETE THE SURGERY. DELAY 20MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6957420 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002747, K211176. 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.