REFLECTION 71330001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010196590), received between Nov 27, 2017 and Aug 23, 2022 — classified as 15 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2022, THE PATIENT HAD AN INFECTION. A REVISION SURGERY WAS ADDRESSED TO EXPLANT ALL THE IMPLANTS (OXINIUM FEM HD 12/14 32MM +4, R3 20 DEG XLPE ACET LNR 36MM X 52MM, R3 0 HOLE HA CTD ACET SHELL 52MM, REF INTERFIT THRD HOLE COVER AND POLARSTEM STEM LAT.TI/HA 1 NON-CEM) AND INSERT CEMENT SPACERS. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 15274449 ↗
• MalfunctionSep 30, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REFLECTION INTERFIT THREADED HOLE COVER DID NOT SCREWED CORRECTLY. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITH A DELAY LESS THAN OR EQUAL TO 30MIN. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558613 ↗
• MalfunctionSep 30, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REFLECTION INTERFIT THREADED HOLE COVER DID NOT SCREWED CORRECTLY. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, AFTER A DELAY LESS THAN OR EQUAL TO 30MIN. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558548 ↗
• InjuryAug 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A THA SURGERY, AFTER IMPLANTING THE R3 3 HOLE ACET SHELL 56MM CUP, A REF INTERFIT THIRD HOLE COVER CENTRAL SCREW WAS IMPLANTED, WHICH EVENTUALLY GOT BLOCKED AND ITS EXTRACTION WAS IMPOSSIBLE. SURGEON WAS FORCED TO REMOVE THE ALREADY IMPLANTED R3 3 HOLE ACET SHELL 56MM AND REPLACE IT WITH ANOTHER OF THE SAME SIZE; SURGEON DECIDES TO IMPLANT IT WITHOUT A CENTRAL SCREW. SURGERY WAS COMPLETED SUCCESSFULLY AFTER A NON SIGNIFICANT DELAY, WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285316 ↗
• InjuryAug 4, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A THR SURGERY, AFTER IMPLANTING THE R3 CUP, THE CENTRAL SCREW-PLUG WAS IMPLANTED. THE SCREW APPEARS TO BE PROPERLY ADJUSTED AND IMPLANTED. WHEN INSERTING AN UNKNOWN XLPE LINER IT IS IMPOSSIBLE TO IMPACT IT ON THE CUP. THE PHYSICIAN DECIDES TO REMOVE THE INTERFIT THREADED HOLE COVER AND INSERTS THE PLASTIC WITHOUT THE CENTRAL SCREW-CAP. THE XLPE LINER THIS TIME IS CORRECTLY IMPLANTED. SURGERY WAS COMPLETED AFTER A NON SIGNIFICANT DELAY, PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277458 ↗
• MalfunctionJul 15, 2021Positioning Failure; Incomplete or Inadequate Connection; Positioning Failure; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CENTRAL SCREW IN THE REF INTERFIT THRD HOLE COVER TILTED IN SUCH WAY WHEN CLOSING THE CENTRAL HOLE THAT THE INSERTION OF THE INLAY WAS NOT POSSIBLE AND THE ALREADY IMPLANTED R3 0 HOLE ACET SHELL 52MM HAD TO BE REMOVED. THE SURGEON TRIED INTRAOPERATIVELY TO REMOVE THE JAMMED HOLE-COVER SCREW WITH THE RIGID SCREWDRIVER R3 AND A HEX WRENCH. HOWEVER, THE LAST ATTEMPT WITH THE HEX WRENCH FAILED COMPLETELY, BECAUSE IT BROKE OFF AND A PART OF THE HEX WRENCH IS STILL STUCK IN THE THREAD OF THE SCREW AND CUP. SURGERY WAS SUCCESSFULLY COMPLETED BY IMPLANTING AN IDENTICAL REPLACEMENT CUP IMPLANT WITH REPLACEMENT CENTRAL SCREW, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171140 ↗
• MalfunctionJul 14, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CENTRAL SCREW COULD NOT BE SCREWED IN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166160 ↗
• InjuryJul 7, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING HIP REPLACEMENT, TWO (2) REFLECTION INTERFIT THREADED HOLE COVERS FAILED TO BE SCREWED INTO THE IMPLANTED R-3 ACETABULAR CUP 52-MM. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. THIS CHANGE WAS MADE IN A WAY IN WHICH THE CUP HOLE WAS LEFT UNSCREWED AND A R-3 XLPE R3 XLPE ACETABULAR LINER 52/36-MM WAS INSERTED DIRECTLY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129374 ↗
• InjuryJul 7, 2021Failure to Align; No Apparent Adverse Event; Failure to Align; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING HIP REPLACEMENT, TWO (2) REFLECTION INTERFIT THREADED HOLE COVERS FAILED TO BE SCREWED INTO THE IMPLANTED R-3 ACETABULAR CUP 52-MM. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. THIS CHANGE WAS MADE IN A WAY IN WHICH THE CUP HOLE WAS LEFT UNSCREWED AND A R-3 XLPE R3 XLPE ACETABULAR LINER 52/36-MM WAS INSERTED DIRECTLY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129368 ↗
• InjuryApr 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO WEAR. THE PATIENT EXPERIENCED FALLING. REFLECTION XLPE ACETABULAR LINER ((B)(4)), OXINIUM HEAD 10/12 28MM +5 EXT ((B)(4)) AND REF INTERFIT THRD HOLE COVER ((B)(4)) DEVICES WERE EXPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Physical Asymmetry

  MAUDE report 11612103 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 DUE TO AN INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11568100 ↗
• InjuryJan 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE DEVICE, COMPATIBLE WITH AN R3 CUP, COULD NOT BE SCREWED INTO THE CENTRAL THREAD OF THE R3 CUP. AN UNSPECIFIED CHANGE IN SURGICAL TECHNIQUE WAS NEEDED IN ORDER TO COMPLETE THE PROCEDURE. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165406 ↗
• MalfunctionJan 6, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE CAP DOES NOT SCREW IN PROPERLY. INSTRUMENTS INSIDE THE PATIENT. PROCEDURE WAS FINISHED WITH A BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124809 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL THE COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9349951 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL THE COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9349938 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. STEM, HEAD AND ACETABULAR LINER REMOVED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8276394 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY AS CONSEQUENCE OF A FRACTURED ACETABULUM. NO FALL OR OTHER INCIDENT OCCURRED.

  Patient problems: Hip Fracture

  MAUDE report 7390959 ↗
• 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 7104645 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION, WHICH INVOLVED REMOVAL OF ALL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 7058459 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION, WHICH INVOLVED REMOVAL OF ALL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 7058458 ↗

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