NA 71362752Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION REAMER DOME 52MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010456908), received between Sep 12, 2017 and Mar 1, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2021Break; Break
IT WAS REPORTED THAT DURING AN OFFICE INSPECTION, IT WAS FOUND THAT THE REAMER DOME 52MM IS BROKEN. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11391236 ↗MalfunctionJun 3, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, WHILE REAMING THE ACETABULUM, IT WAS DISCOVERED THAT THE REAMER HAD BECOME DULL. ALSO, DEVICE BROKE OVER THE PATIENT INCISION, THERE WAS NO HARM TO THE PATIENT, NO PIECES WERE LEFT IN THE PATIENT, PROCEDURE CONTINUED WITHOUT DELAY USING ANOTHER SIZE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8663102 ↗MalfunctionSep 12, 2017Break; Break
IT WAS REPORTED THE DOCTOR WAS USING THE SIZE 52 REAMER AND WHEN HE PULLED OUT THE REAMER IT WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6859341 ↗
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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