REFLECTION 71332525Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010460462), received between Dec 11, 2017 and Sep 27, 2021 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. IT WAS REPORTED THAT PLAINTIFF UNDERWENT EXPLANTATION OF THE REF SPHER HEAD SCREW 25MM. IT IS UNKNOWN IF THE EXPLANTATION WAS PERFORMED DURING THE PRIMARY LEFT THA OR IF IT WAS PERFORMED DURING A REVISION SURGERY AFTER THE PRIMARY THA, HOWEVER THE DATE OF THE INCIDENT WAS (B)(6) 2019. PLAINTIFF EXPERIENCED UNSPECIFIED INJURIES. ADDITIONAL DETAILS ARE UNKNOWN. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12538248 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA ON (B)(6) 2021, THE PATIENT EXPERIENCED STINGING NUMBING PAIN DOWN LEG WHEN STANDING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DURING REVISION SURGERY, SURGEON FELT LIKE THE ACETABULAR SCREWS MAY BE CAUSING THE ISSUE, SO HE REMOVED BOTH ACETABULAR SCREWS AND PUT IN ONE SHORTER SCREW, ALSO LINER AND HEAD WERE REPLACED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Numbness; Pain; Paresthesia

  MAUDE report 11735866 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA ON (B)(6) 2021, THE PATIENT EXPERIENCED STINGING NUMBING PAIN DOWN LEG WHEN STANDING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DURING REVISION SURGERY, SURGEON FELT LIKE THE ACETABULAR SCREWS MAY BE CAUSING THE ISSUE, SO HE REMOVED BOTH ACETABULAR SCREWS AND PUT IN ONE SHORTER SCREW, ALSO LINER AND HEAD WERE REPLACED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11735277 ↗
• InjuryJan 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE SCREW WOULD NOT SEAT ALL THE WAY IN THE CUP. SURGEON STATED THE SCREW WAS SITTING UP ABOUT 1MM. WHEN TRYING TO IMPACT THE LINER THE SCREW ENDED UP DAMAGING THE CONVEX SIDE OF THE LINER DURING THE IMPACTION. THE PROBLEM WAS DISCOVERED THAT THE SCREW HAVEN¿T SEATED PROPERLY WHEN THE LINER DIDN¿T LOCK INTO PLACE. INSTRUMENTS WERE INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121261 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ARTHROSCOPY PROCEDURE IT WAS NOTICED THAT THERE WAS A DISPLACEMENT OF THE ACETABULAR SCREW. NO DELAY REPORTED.

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

  MAUDE report 10788679 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ARTHROSCOPY PROCEDURE IT WAS NOTICED THAT THERE WAS A DISPLACEMENT OF THE ACETABULAR SCREW. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788628 ↗
• InjuryApr 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE HAD THE PRIMARY HIP REPLACEMENT (SPECTRON/ R3) (B)(6) 2017. PATIENT COMPLAINED OF ONGOING GLUTEAL PAIN. CT REVIEW IN 2019 SHOWS ACETABULAR SCREW PROTRUDING POSTERIORLY. THE PATIENT REFERRED TO A SPORTS DOCTOR WHO ADVISED CORTISONE INJECTION AROUND THIS SCREW WHICH TEMPORARILY RELIEVED PAIN. THE SURGEON RECOMMENDED REVISION SURGERY TO REMOVE SCREW. DURING SURGERY, LINER, FEMORAL HEAD AND ACETABULAR SCREW WERE REMOVED FOLLOWING RECOMMENDED SURGICAL TECHNIQUE WITH NIL ISSUES, NEW LINER AND FEMORAL HEAD IMPLANTED.

  Patient problems: Injury

  MAUDE report 9928894 ↗
• MalfunctionDec 24, 2019Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A THR SURGERY, THE DOCTOR PREPARED ACETABULUM AND TOOK A TRIAL OF CUP SIZE 50. IT WAS GOOD AND FIXED WELL SO HE TOOK THE ORIGINAL REFLECTION SHELL AND IT FIXED WELL. HE THEN PUT A 25MM SCREW FOR BETTER FIXATION, THEN FIXED LINER FOR 32 MM HEAD. LATER HE PREPARED THE FEMUR FIX STEM AND TOOK TRIAL FOR THE HEAD AND REDUCED THE HIP JOINT. WHEN HE DISLOCATED THE HIP TO PUT THE ORIGINAL HEAD REFLECTION SHELL, THE LINER CAME OUT AND THE SCREW REMAINED INSIDE THE BONE (IT WAS LATER REMOVED). HE TRIED TO FIX IT AGAIN BUT DID NOT SUCCEED AND THEN HE TOOK SIZE 54 MM. THIS CAUSED A DELAY OF 30 MINUTES TO AN HOUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517190 ↗
• InjuryApr 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS CARRIED OUT FOR A HIP PROSTHESIS EXCHANGE DUE TO IT BROKE AT THE SHAFT.

  Patient problems: Injury

  MAUDE report 8478665 ↗
• InjuryMar 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT UPON REVIEWING POST OP XRAYS IMMEDIATELY FOLLOWING CLOSURE ON A PRIMARY HIP REPLACEMENT, IT WAS FOUND THAT ONE (POSSIBLY BOTH) SCREWS IMPLANTED DURING THE CASE ARE DISASSOCIATED WITH THE R3 CUP. TWO SCREWS WERE PUT IN RESPECTIVELY. EACH LOOK TO BE INTACT FROM THE POST OP X-RAY. THIS SUGGESTS THAT THE SCREWS WENT THROUGH THE R3 CUP. NEITHER THE FELLOW OR ATTENDING OPERATING APPLIED ABNORMAL AMOUNTS OF FORCE WHEN IMPLANTING THE SCREWS.

  Patient problems: Injury

  MAUDE report 8417292 ↗
• InjuryMar 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT UPON REVIEWING POST OP XRAYS IMMEDIATELY FOLLOWING CLOSURE ON A PRIMARY HIP REPLACEMENT, IT WAS FOUND THAT ONE (POSSIBLY BOTH) SCREWS IMPLANTED DURING THE CASE ARE DISASSOCIATED WITH THE R3 CUP. TWO SCREWS WERE PUT IN RESPECTIVELY. EACH LOOK TO BE INTACT FROM THE POST OP X-RAY. THIS SUGGESTS THAT THE SCREWS WENT THROUGH THE R3 CUP. NEITHER THE FELLOW OR ATTENDING OPERATING APPLIED ABNORMAL AMOUNTS OF FORCE WHEN IMPLANTING THE SCREWS.

  Patient problems: Injury

  MAUDE report 8417235 ↗
• InjuryMar 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS.

  Patient problems: Injury

  MAUDE report 8410210 ↗
• 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 8276379 ↗
• InjuryJun 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND DISLOCATION OF THE CUP. THE ACETABULAR SHELL, THE LINER, THE FEMORAL HEAD AND THE HEAD SCREW WERE EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 7608424 ↗
• InjuryJun 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO RECURRENT DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7564079 ↗
• InjuryDec 20, 2017Adverse 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 UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 7133845 ↗
• 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 7105135 ↗

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