R3 71367954Recalls & reported problems
Smith & Nephew, Inc. · R3 20 DEGREE 36MM INNER DIAMETER TRIAL ACETABULAR LINER 54MM OUTER DIAMETER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010599889), received between Feb 28, 2019 and Feb 2, 2021 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2021Break; Break
IT WAS REPORTED THAT, DURING SURGERY, A FIN ON THE OUTSIDE OF THE TRIAL INSERT BROKE OFF OF THE TRIAL, INSIDE THE PATIENT. THE SURGEON DID NOT KNOW WHETHER IT HAPPENED DURING SEATING OF TRIAL LINER OR EXTRACTION OF TRIAL LINER. THE LINER TRIAL, AS WELL AS THE FULL PIECE OF THE FIN THAT BROKE OFF, WAS REMOVED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, THERE WAS NO DELAY. NO PIECE OF THE LINER WAS LEFT IN THE PATIENT ACCORDING TO THE SURGEON: THE PIECE WAS MATCHED UP WITH THE LINER AND THE SURGEON WAS CONFIDENT THAT NOTHING WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11267128 ↗MalfunctionFeb 28, 2019Break; Break
IT WAS REPORTED THAT A SMALL PIECE OF THE INSTRUMENT BROKE DURING SURGERY. THE BROKEN PIECE WAS RECOVERED. NO INJURIES OR DELAYS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8380039 ↗
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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