REFLECTION 71332515Recalls & reported problems

Smith & Nephew, Inc. · REFLECTION SPHERICAL HEAD SCREW 15MM · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010460448), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

Most reported problems

Device problems

Loose or Intermittent Connection1

Patient problems

Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 21, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR THE THIRD TIME. ASEPTIC LOOSENING. HIP PREPPED AND DRAPED, JOINTLY OPENED, SPECIMENS TAKEN. JOINT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD REMOVED, POLY LINER AND CUP AND SCREWS REMOVED. EXISTING SOCKET REAMED TO A BLEEDING BONE BED. IMPLANT TRIALED, JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE. DEFINITIVE ACETABULAR IMPLANT INSERTED WITH BONE CEMENT. TRIPOLAR LINER/HEAD TRIALED VIA REDUCTION, HIP STABLE, DEFINITIVE TRIPOLAR IMPLANTS INSERTED AND HIP REDUCED, HIP CLOSED. NO MORE INFORMATION IS AVAILABLE.
Patient problems: Injury
MAUDE report 9360066 ↗

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, Classified
Tandem 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 · Terminated
SPHERICAL 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

Device details

UDI-DI	`03596010460448`
Brand	REFLECTION
Model	71332515
Company	Smith & Nephew, Inc.
Product code	MEH · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Class	Class 2
FDA submission	K211176, K990666
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 25, 2025

Device type (GMDN): Orthopaedic bone screw (non-sliding)

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

Novation 130-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls156 reports
Novation 130-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls79 reports
CORAIL 3L92511
Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
158 reports
Acumatch A Series 138-36-29
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
3 recalls1 report
Novation 136-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls43 reports
Novation 130-32-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls33 reports
Novation 132-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls26 reports
Novation 136-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls22 reports

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

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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