REFLECTION 71333345Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010479754), received between Aug 17, 2018 and Feb 3, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K022902, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Degraded; Degraded

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED APPROXIMATELY 20 YEARS AGO, THE PATIENT EXPERIENCED A WEAR OF THE REFLECTION LINER. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE LINER WAS EXCHANGED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 16297878 ↗
• MalfunctionAug 5, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A HIP SURGERY, THE REF XLPE 36 20 DEG 54-56 F DID NOT LOCK AFTER SEVERAL ATTEMPTS TO THE CUP. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285682 ↗
• MalfunctionAug 4, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REF XLPE 36 20 DEG 54-56 F WAS NOT GETTING LOCKED WITH THE 54 MM OD REFLECTION THREE HOLE ACETABULAR SHELL. THE SHELL DID FITTED AND LOCKED APPROPRIATELY WITH THE TRIAL LINER AND THE REPLACEMENT LINER. SURGERY WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276842 ↗
• MalfunctionJun 30, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING THR, THE REF XLPE 36 20 DEG 54-56 F WAS INSTALLED DURING THE OPERATION, AND THE TRIAL WAS TESTED AFTER THE FEMUR WAS FINISHED. AFTER TESTING THE RANGE OF MOTION AND DISLOCATION OF THE JOINT, THE REF XLPE 36 20 DEG 54-56 F ON THE TRIAL HEAD FELL OFF. THE LINER WAS DEFORMED AND COULD NOT BE USED NORMALLY. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097478 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REVISION DUE TO PAIN THAT BECAME PROGRESSIVELY WORSE. THE WHOLE SYSTEM WAS REPLACED.

  Patient problems: Pain

  MAUDE report 9362847 ↗
• 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 TRIALED 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: Pain

  MAUDE report 8307817 ↗
• InjuryAug 17, 2018Appropriate Device Problem Term/Code Not Available

  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 7795361 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022902, 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.