REFLECTION 71336500Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010197634), received between Sep 7, 2017 and Oct 19, 2023 — classified as 9 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

7 other recalls cover devices cleared under the same FDA submission (K070756, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, WHEN TIGHTENING ONE (1) REF THREADED HOLE COVER INTO A NO HOLE R3 SHELL, THE COVER TIGHTENED SLIGHTLY AND THEN PROCEEDED TO SCREW RIGHT THROUGH THE SHELL INTO THE SUPERIOR SIDE OF THE SHELL. NORMALLY THEY TIGHTEN TO A POSITIVE STOP. THE THREADED HOLE COVER ENDED UP UNDER THE R3 ACETABULAR CUP, IN EFFECT WEDGED THERE BY THE CUP THAT HAD BEEN INSERTED. THE ONLY WAY THE SURGEON COULD REMOVE THE THREADED HOLE COVER WOULD BE TO REMOVE THE ALREADY IMPACTED AND SEATED R3 SHELL WHICH HE DECIDED NOT TO DO, INSTEAD LEAVING THE THREADED HOLE COVER IN SITU WHERE IT WAS, WEDGED UNDER THE R3 CUP. THE SURGEON LEFT THE HOLE COVER IN SITU AS IT CANNOT MIGRATE ANYWHERE ELSE (MOVE AROUND LIKE A LOOSE FOREIGN BODY) OR CAUSE SUCH ISSUES THAT WOULD NEED FURTHER INTERVENTION SURGICALLY OR OTHERWISE. THE SURGEON FOUND THIS EVENT UNUSUAL, AS HE HAS USED HUNDREDS OF THESE BEFORE AND THIS HAS NEVER HAPPENED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965848 ↗
• InjurySep 9, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING THR SURGERY, THE REF THREADED HOLE COVER WENT THROUGH TO BACK OF THE SHELL, WHEN IT WAS INSERTED TO THE SHELL. THE SHELL WAS RETRIEVED TO REMOVE THE HOLE COVER, THEN, THE SHELL WAS PLACED AGAIN WITH A BACK UP HOLE COVER. THE SURGEON USED SCREWS TO ASSURE THE SHELL FIXATION AND USED THE SAME SCREW HOLES TO RE-INSERT THE SHELL IN THE ACETABULUM. SURGERY WAS PERFORMED, AFTER A A NON SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393276 ↗
• MalfunctionAug 29, 2022Crack; Deformation Due to Compressive Stress; Positioning Problem; Crack; Deformation Due to Compressive Stress; Positioning Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE SCREWING THE REF THREADED HOLE COVER INTO THE R3 SHELL THERE WAS NO RESISTANCE. THE IMPLANT IS DEFORMED AND CRACKED. SURGERY WAS FINISHED WITH A S+N BACK-UP DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317161 ↗
• MalfunctionJun 8, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS FOUND THAT THE LABELLING OF THE BOX OF A REF THREADED HOLE COVER DID NOT MATCH THE LABELLING OF THE DEVICE THAT CAME INSIDE. THE REFERENCE NUMBER ON THE BOX WAS (B)(4) WHICH CORRESPONDS TO A REF THREADED HOLE COVER, BUT THE REFERENCE OF THE DEVICE THAT CAME INSIDE THE BOX WAS (B)(4) WHICH CORRESPONDS TO A R3 SCREW HOLE COVER. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A BACK UP REF THREADED HOLE COVER. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640191 ↗
• MalfunctionJul 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A PRIMARY TOTAL HIP REPLACEMENT SURGERY, ONE (1) REF THREADED HOLE COVER CANNOT BE SCREWED CORRECTLY. SURGERY WAS RESUMED, AFTER A DELAY LESS THAN OR EQUAL TO 30MINS, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201207 ↗
• MalfunctionMay 13, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A THR SURGERY THE REF THREADED HOLE COVER WHICH ARE USED WITH THE REFLECTION 0-HOLE UNCEMENTED CUPS DID NOT STOP WHEN IT WAS SCREWED INTO THE HOLE IN THE BOTTOM OF THE CUP. THE REFLECTION THREADED CENTRAL HOLE COVER DIDN'T GO ALL THE WAY THROUGH THE SHELL AND ARE STILL ATTACHED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, IT WAS COMPLETED USING THE SAME DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817203 ↗
• MalfunctionMay 13, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A THR SURGERY THE REF THREADED HOLE COVER WHICH ARE USED WITH THE REFLECTION 0-HOLE UNCEMENTED CUPS DID NOT STOP WHEN IT WAS SCREWED INTO THE HOLE IN THE BOTTOM OF THE CUP. THE REFLECTION THREADED CENTRAL HOLE COVER DIDN'T GO ALL THE WAY THROUGH THE SHELL. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816873 ↗
• MalfunctionMay 13, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A THR SURGERY THE REF THREADED HOLE COVER WHICH ARE USED WITH THE REFLECTION 0-HOLE UNCEMENTED CUPS DID NOT STOP WHEN IT WAS SCREWED INTO THE HOLE IN THE BOTTOM OF THE CUP. THE REFLECTION THREADED CENTRAL HOLE COVER DIDN'T GO ALL THE WAY THROUGH THE SHELL AND ARE STILL ATTACHED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, IT WAS COMPLETED USING THE SAME DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816871 ↗
• 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 11166947 ↗
• MalfunctionDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, HOLE COVER PASSED COMPLETELY THROUGH THE ACETABULAR SHELL AND COULD NOT BE RETRIEVED AS SHELL WAS ALREADY SCREWED INTO PLACE. NO INJURY AND A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS CONCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9425401 ↗
• InjuryApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A POSTOPERATIVE INFECTION HAS OCCURRED IN THE PATIENT WHO RECEIVED THESE IMPLANTS. THE SURGEON INFORMED THE SALES REP ABOUT THIS.

  Patient problems: Unspecified Infection

  MAUDE report 8507261 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTS ILIOPSOAS TENDINITIS ON OPERATIVE HIP. THIS WAS FOUND AFTER SURGERY. DEVICE BACK UP NOT APPLICABLE AND DELAY DURING PROCEDURE IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 8266513 ↗
• MalfunctionSep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED ON (B)(6) 2010 DUE TO SWELLING. RIGHT HIP BURSA WAS INJECTED.

  Patient problems: Injury

  MAUDE report 7879098 ↗
• InjurySep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011 A MEDICAL INTERVENTION WAS PERFORMED DUE TO PAIN. A STEROID INJECTION WAS PERFORMED TO TREAT SEVERE PAIN THE PATIENT WAS PRESENTING.

  Patient problems: Reaction, Injection Site

  MAUDE report 7878330 ↗
• InjuryJun 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO RECURRENT DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7564104 ↗
• 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 7262498 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND FEVER, THE TESTS WERE NON CONCLUSIVE OF INFECTION.

  Patient problems: Fever; Pain

  MAUDE report 7184219 ↗
• InjurySep 7, 2017Misconnection; Misconnection

  IT WAS REPORTED THAT THE LINER HAD DIFFICULTY SEATING AND WOULD NOT STAY LOCKED INSIDE SHELL. AFTER TRYING OTHER SHELL AND LINER, THEY REALIZE THE MISSFITTING DEVICE WAS THE HOLE COVER. THIS CAUSED A DELAY IN THE SURGERY GREATER THAN 30 MINUTES.

  Patient problems: Injury

  MAUDE report 6849207 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070756, 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.
• Z-2332-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM
• Z-2336-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54M
• Z-2335-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 7133866
• Z-2331-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 5
• Z-2333-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546
• Z-2334-2020 · Apr 22, 2020 · Open, Classified
  smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50M