REFLECTION 71332530Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010460479), received between Apr 7, 2017 and Feb 14, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2026Malposition of Device

  IT WAS REPORTED THAT, DURING A REDAPT FULLY POROUS CUP SURGERY, ONE (1) REF SPHER HEAD SCREW 30MM HAD GONE BEYOND THE SCREW HOLE AND LOWER THAN THE PETALS OF ONE (1) REDAPT FULLY POROUS SHELL 58MM, THEREFORE THE CANCELLOUS SCREW WAS REMOVED WITH SOME DIFFICULTY. SURGEON DECIDED TO NOT REPLACE THE SCREW, THEREFORE, LEAVING A VOID IN PATIENT'S BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24341241 ↗
• MalfunctionSep 12, 2025Flaked; Material Deformation; Material Twisted/Bent; Positioning Problem; Flaked; Material Deformation; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN THE SURGEON WAS TIGHTENING ONE (1) REF SPHER HEAD SCREW 30MM INSIDE OF THE CUP, THE SCREW PULLED ALL THE WAY THROUGH THE CUP, DEFORMING THE HEAD OF THE SCREW. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23041806 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS SCHEDULED TO POTENTIALLY REMOVE AND REPLACE ACETABULAR CUP AND LINER DUE TO SUSPECTED LOOSENING DUE TO LYSIS. UPON INSPECTION THE CUP WAS WELL FIXED AND A CYST WAS FOUND UNDER A SECTION OF THE CUP. THIS WAS EXCISED AND BONE GRAFT PLACED THROUGH THE HOLE IN THE CUP. A NEW LINER AND FEMORAL HEAD WERE PUT IN PLACE AND THE WOUND CLOSED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Cyst(s)

  MAUDE report 11095645 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY OF PRIMARY THR (B)(6) 2020. IT WAS INFORMED THAT THE PATIENT HAD ANOTHER REVISION SURGERY IN (B)(6) 2020, BECAUSE IT PRESENTED A PERIPROSTHETIC FRACTURING FEMUR. THE SURGEON REMOVED THE FEMORAL PROSTHESIS AND THE FEMORAL HEAD. ALSO, IT WAS KNOWN THAT THE STEM WAS SUBSIDED. THE SURGEON FIXED THE PROBLEM WITH THREE CABLES. THE SURGEON DID NOT BLAME THE DEVICES IN THE DEVELOPMENT OF THE PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10230711 ↗
• 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 TRAILED, JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE. DEFINITIVE ACETABULAR IMPLANT INSERTED WITH BONE CEMENT. TRIPOLAR LINER/HEAD TRAILED VIA REDUCTION, HIP STABLE, DEFINITIVE TRIPOLAR IMPLANTS INSERTED AND HIP REDUCED, HIP CLOSED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9353498 ↗
• MalfunctionNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IT APPEARS THAT A 30MM ACETABULAR SCREW WENT THROUGH THE R3 CUP DURING INSERTION. THIS WAS NOT NOTICED UNTIL POST OP X-RAY WAS TAKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310405 ↗
• MalfunctionNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IT APPEARS THAT A 30MM ACETABULAR SCREW WENT THROUGH THE R3 CUP DURING INSERTION. THIS WAS NOT NOTICED UNTIL POST OP X-RAY WAS TAKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310359 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, AFTER THE PRIMARY R3 SHELL WAS IMPACTED, JUST ABOUT TO PLACE A SCREW IN THE SHELL WHEN IT WAS NOTICED THE SCREW HAD COME APART. THE SURGEON MANAGED TO RETRIEVE THE PIECE OF BROKEN SCREW FROM THE PATIENT AND USED A DIFFERENT SCREW (BACK-UP). NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258164 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE POST OPERATIVE FILM LOOKS LIKE THE SCREW WENT BEYOND THE SHELL. THERE IS NO INFORMATION THAT AN INTERVENTION OCCURRED DUE TO THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741896 ↗
• InjuryMar 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A TOTAL HIP CASE, THE SCREW PASSED BY THE ACETABULAR CUP.

  Patient problems: Injury

  MAUDE report 8409189 ↗
• MalfunctionJan 25, 2019Calibration Problem; Unintended Movement; Calibration Problem; Unintended Movement

  IT WAS REPORTED THAT AFTER A TOTAL HIP REPLACEMENT PROCEDURE, POST OPERATIVE FILM SHOWED THAT THE SCREW HAD GONE COMPLETELY THROUGH THE SHELL. NO DELAY REPORTED. NO REVISION SURGERY PERFORMED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8278472 ↗
• MalfunctionJan 25, 2019Calibration Problem; Unintended Movement; Calibration Problem; Unintended Movement

  IT WAS REPORTED THAT AFTER A TOTAL HIP REPLACEMENT PROCEDURE, POST OPERATIVE FILM SHOWED THAT THE SCREW HAD GONE COMPLETELY THROUGH THE SHELL. NO DELAY REPORTED. NO REVISION SURGERY PERFORMED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8278440 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ASPIRATION ON THE LEFT HIP DUE TO AN INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8139865 ↗
• InjurySep 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, THE HEAD POPPED OUT OF THE LINER. THE REFLECTION CUP, THE CONSTRAINED LINER, THE FEMORAL HEAD AND THE REFLECTION 30MM SCREWS WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 7917258 ↗
• InjurySep 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, THE HEAD POPPED OUT OF THE LINER. THE REFLECTION CUP, THE CONSTRAINED LINER, THE FEMORAL HEAD AND THE REFLECTION 30MM SCREWS WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 7917255 ↗
• InjuryApr 7, 2017Failure To Adhere Or Bond; Break; Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY OCCURED DUE TO BREAKAGE OF SCREW. PATIENT COMPLAINED OF PAIN IN (B)(6) 2017 BUT X-RAYS DIDN'T SHOW ANYTHING. SURGEON DECIDED TO OPERATE AS HE WAS AWARE THAT THE TROCHANTER HAD A NON-UNION. INTRAOPERATIVELY IT WAS DISCOVERED THAT 30MM SPHERICAL HEAD SCREWS HAD BROKEN. SURGEON REVISED THE CUP, 5 FIXATION SCREWS AND THE LINER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6471715 ↗

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