REFLECTION 71363250Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION TRIAL LINER 20 DEGREE 32MM 50-52 OUTER DIAMETER · Class 2
All models of REFLECTION (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010530035), received between Sep 1, 2020 and Apr 2, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K123598); 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING THR, A SCREW OF ONE (1) TRIAL 20 DEG 32MM 50-52 OD BROKE DURING TIGHTENING. ALL PIECES WERE REMOVED BY HAND FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755996 ↗MalfunctionSep 5, 2022Fracture; Fracture
IT WAS REPORTED THAT THE CENTER SCREWS ARE BROKEN OUT OF FOUR (4) TRIAL 20 DEG 32MM 50-52 OD. THE SURGERY FINISHED WITH THE SAME DEVICE. NO INJURY OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15358672 ↗InjuryDec 3, 2021Break; Break
IT WAS REPORTED THAT, DURING A THR, A REFLECTION TRIAL 20 DEGREES 32 MM 50-52 BROKE INSIDE THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED; HOWEVER, NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12924174 ↗MalfunctionSep 1, 2020Break; Break
IT WAS REPORTED THAT DURING INSTRUMENT INSPECTION THE DEVICE WAS FOUND BROKEN. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10478887 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.
- Z-0730-2019 · Jan 7, 2019 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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