REFLECTION 71332520Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION SPHERICAL HEAD SCREW 20MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010460455), received between Feb 10, 2018 and Feb 11, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K211176, K990666); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Delivered as Unsterile Product1
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Peeled/Delaminated1
Patient problems
- Joint Dislocation2
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING A THR SURGERY WHEN OPENING THE BOX OF ONE (1) REF SPHER HEAD SCREW 20MM IT WAS FOUND THE POUCH HAD BEEN OPENED. THE SURGERY WAS COMPLETED WITHOUT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355276 ↗MalfunctionJul 11, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING SURGERY, ONE (X1) REF SPHER HEAD SCREW 20MM WAS INSERTED AND REMOVED. IT WAS FOUND A WIRE-LIKE METAL WAS COMING OUT OF THE SCREW BODY. USING BACK UP DEVICE, THE SURGERY WAS COMPLETED 5 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17302916 ↗InjuryJun 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY DUE TO RECURRENT DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 7564077 ↗InjuryMay 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD FIRST STAGE REVISION HIP ARTHROPLASTY DUE TO INFECTED THR ON (B)(6) 2018 BY DR. (B)(6). PRIMARY PROCEDURE WAS DONE AT (B)(6) BY DR. (B)(6) ON (B)(6) 2018.
Patient problems: Unspecified Infection
MAUDE report 7489566 ↗InjuryFeb 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
PATIENT POSITIONED AND HIP DISLOCATED. LINER AND SCREWS REMOVED CUP WAS LOOSE. REMOVED CUP REAMED ACETABULUM AND IMPLANTED A 52MM MULTIHOLE CUP AND THREE SCREWS. A CONSTRAINED LINER INSERTED AND CHECKED TO BE LOCKED IN THE CUP. HIP REDUCED USING A 22MM STRYKER HEAD. HIP STABLE.
Patient problems: Joint Dislocation
MAUDE report 7262495 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211176, K990666. One submission often covers many models, so check the product and lot details in each record.
- Z-0326-2025 · Oct 15, 2024 · Open, ClassifiedTandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
- Z-2297-2016 · Jul 6, 2016 · TerminatedSPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revis
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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