REFLECTION, MICROSTABLE 71742854Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION LINER 28 INNER DIAMETER 54-56 OUTER DIAMETER 20 DEGREE SIZE F · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010232274), received between Sep 19, 2017 and Apr 19, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Degraded” (3 reports).
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
Device problems
- Degraded3
- Insufficient Device Problem Information2
- Naturally Worn2
- Fracture1
Patient problems
- Injury5
- Failure of Implant1
- Joint Laxity1
- Metal Related Pathology1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2023Degraded; Degraded
IT WAS REPORTED THAT, AFTER A SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED INSTABILITY, SCANS INDICATED LINER WEAR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A REF LNR 28ID 20 DEG SZ F AND A COCR 12/14 FEM HEAD 28 +0 WERE EXCHANGED. THE LINER THAT WAS EXPLANTED DISPLAYED ECCENTRIC WEAR DUE TO ITS AGE AND MATERIAL. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 16773443 ↗InjuryFeb 1, 2023Degraded; Degraded
IT WAS REPORTED THAT, AFTER TWENTY-FIVE (25) YEARS OF A THR SURGERY, IT WAS NOTICED THAT THE REF LNR 28ID 20 DEG SZ F WAS WORN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN ORDER TO SWAP THE IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 16277881 ↗InjuryMar 30, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT, AFTER A (B)(6) YEARS OLD THR, A REVISION SURGERY WAS PERFORMED DUE TO EXTENSIVE POLY WEAR. SURGEON PERFORMED A STANDARD POSTERIOR APPROACH AS PER SURGICAL TECHNIQUE ALSO A DEBRIMENT OF THE AFFECTED TISSUE. METALOSIS WAS FOUND. THE ZIRC 12/14 FEM HD 28 + 4 AND REF LNR 28ID 20 DEG SZ F WERE EXPLANTED AND EXCHANGE FOR NEW POLY AND HEAD. PATIENT OUTCOME IS UNKNOWN.
Patient problems: Metal Related Pathology
MAUDE report 11587198 ↗InjuryMar 31, 2020Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. STEM AND FEMORAL HEAD WERE EXPLANTED AND REPLACED FOR ZIMMER BIOMET STEM.
Patient problems: Injury
MAUDE report 9902698 ↗InjuryDec 16, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO WEAR.
Patient problems: Injury
MAUDE report 9477301 ↗InjuryJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE LINER AND THE HEAD WERE REPLACED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2003.
Patient problems: Injury
MAUDE report 8238614 ↗InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, DURING A HIP REVISION SURGERY, (B)(4) ACETABULUM CUP AND 54-56 LINER WERE USED, AFTER THE CUP WAS IMPLANTED PROPERLY, THE LINER COULDN'T BE IMPLANTED TO THE LOCATION, AFTER SEVERAL TIMES TRIALS, STILL FAILED. THE PATIENT CONDITION WAS NOT WELL, SO THE SURGEON HAD TO CHOOSE CUP+ BONE CEMENT TO COMPLETE THE SURGERY. THE POST-SURGERY OUTCOME OF THE PATIENT IS BEING CLOSELY WATCHED.
Patient problems: Injury
MAUDE report 6978119 ↗InjurySep 19, 2017Degraded; Degraded
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LINER WEAR.
Patient problems: Injury
MAUDE report 6876799 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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