REFLECTION 71352855Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION ALL POLY CEMENTED ACETABULAR COMP 28 INNER DIAMETER 55 OUTER DIAMETER 20 DEGREE · Class 2 · Implant
All models of REFLECTION (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010198259), received between Jun 17, 2021 and Dec 6, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Degraded” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Pain2
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2023Degraded; Loosening of Implant Not Related to Bone-Ingrowth; Degraded; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(3) 2010, THE PATIENT EXPERIENCED PAIN AND CLICKING IN HIP, AND A REVISION SURGERY WAS PERFORMED ON (B)(3) 2023 DUE TO WEAR AND LOOSENING OF THE CUP, THE REF CEMENT ACET COM 28/55 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 18274817 ↗InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2002, THE PATIENT REPORTED HIP PAIN. THERE WAS A REVISION SURGERY ON (B)(6) 2021, IN WHICH IT WAS DECIDED TO EXPLANT THE REF CEMENT ACET COM 28/55 AND THE COCR 12/14 FEM HEAD 28 + 4 AND REPLACE THEM. IT WAS REPORTED THAT AFTER THE REPLACEMENT, THE PATIENT WAS STABLE.
Patient problems: Pain
MAUDE report 12020485 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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