REFLECTIONRecalls & reported problems across all models
Smith & Nephew, Inc. · 112 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,162
- Deaths reported
- 0
- Injuries reported
- 314
- Recalls
- 0
We found 112 models of REFLECTION by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 1,162 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and Jun 22, 2026 — classified as 314 injuries, 848 malfunctions.
The most frequently reported specific device problem is “Break” (516 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported REFLECTION problems
Device problems
- Break516
- Fracture203
- Material Deformation79
- Adverse Event Without Identified Device or Use Problem60
- Insufficient Device Problem Information54
- Connection Problem37
- Device Dislodged or Dislocated34
- Detachment of Device or Device Component28
Patient problems
- No Clinical Signs, Symptoms or Conditions708
- No Consequences Or Impact To Patient119
- No Known Impact Or Consequence To Patient106
- Injury90
- No Patient Involvement45
- Joint Dislocation40
- Unspecified Infection30
- Failure of Implant28
REFLECTION models
112 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- REFLECTION 71362295SCREWDRIVER178 reports
- REFLECTION 71362279Prosthesis, hip, femoral component, cemented, metal155 reports
- REFLECTION 71364022Prosthesis, hip, femoral component, cemented, metal131 reports
- REFLECTION 71362299Prosthesis, hip, femoral component, cemented, metal115 reports
- REFLECTION 71364071ORTHOPEDIC MANUAL SURGICAL INSTRUMENT54 reports
- REFLECTION 71362294ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES45 reports
- REFLECTION 71362925Prosthesis, hip, femoral component, cemented, metal29 reports
- REFLECTION 71362297Prosthesis, hip, femoral component, cemented, metal26 reports
- REFLECTION 71362935Prosthesis, hip, femoral component, cemented, metal26 reports
- REFLECTION 71362293PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER24 reports
- REFLECTION 71330001Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- REFLECTION 71336500Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 reports
- REFLECTION 71364023Prosthesis, hip, femoral component, cemented, metal18 reports
- REFLECTION 71332525Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate17 reports
- REFLECTION 71332530Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate16 reports
- REFLECTION 71333324Prosthesis, hip, semi-constrained, metal/polymer, cemented15 reports
- REFLECTION 71362292PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- REFLECTION 71362298Prosthesis, hip, femoral component, cemented, metal13 reports
- REFLECTION 71336452Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous11 reports
- REFLECTION 71333334Prosthesis, hip, semi-constrained, metal/polymer, cemented11 reports
- REFLECTION 71336454Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous9 reports
- REFLECTION 71333373Prosthesis, hip, semi-constrained, metal/polymer, cemented9 reports
- REFLECTION 71333336Prosthesis, hip, semi-constrained, metal/polymer, cemented8 reports
- REFLECTION 71362012APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT7 reports
- REFLECTION 71362290PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- REFLECTION 71333325Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- REFLECTION 71358034Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- REFLECTION 71333345PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- REFLECTION 71323114Prosthesis, hip, constrained, cemented or uncemented, metal/polymer7 reports
- REFLECTION 71333335Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- REFLECTION 71362950Prosthesis, hip, femoral component, cemented, metal6 reports
- REFLECTION 71363654Prosthesis, hip, femoral component, cemented, metal6 reports
- REFLECTION 71323125Prosthesis, hip, constrained, cemented or uncemented, metal/polymer6 reports
- REFLECTION 732109APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT5 reports
- REFLECTION 71333323Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- REFLECTION 71332520Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- REFLECTION 71332535Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- REFLECTION 71363658Prosthesis, hip, femoral component, cemented, metal5 reports
- REFLECTION 71336450Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous4 reports
- REFLECTION 71336456Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous4 reports
- REFLECTION 71336458Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous4 reports
- REFLECTION 71333346PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- REFLECTION 71363250Prosthesis, hip, femoral component, cemented, metal4 reports
- REFLECTION 71336054Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous3 reports
- REFLECTION 71336448Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous3 reports
- REFLECTION 71332540Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- REFLECTION 71333397PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- REFLECTION 71363660Prosthesis, hip, femoral component, cemented, metal3 reports
- REFLECTION 71352243PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- REFLECTION 71352855PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- REFLECTION 71334252Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- REFLECTION 71362291PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- REFLECTION 71362915Prosthesis, hip, femoral component, cemented, metal2 reports
- REFLECTION 71323145Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- REFLECTION 71323144Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- REFLECTION 71333434Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- REFLECTION 71363253Prosthesis, hip, femoral component, cemented, metal2 reports
- REFLECTION 71358065Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- REFLECTION 71334513PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REFLECTION 71332056Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- REFLECTION 71334523PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REFLECTION 71338456Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- REFLECTION 71335150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REFLECTION 71331070PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REFLECTION 71334056Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71336046Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71352849PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REFLECTION 71352852PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REFLECTION 732119Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71336248Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71336252Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71336256Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71336258Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71336460Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71336462Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71362846Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71362850Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71362917Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71334152Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71334154Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71334160Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71333303Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333313Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333315Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333326Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333329Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333337Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333338Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333353Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333365Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333374Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71333375Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REFLECTION 71362851Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71362855Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71332515Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71336444Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- REFLECTION 71332545Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71332560Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REFLECTION 71363255Prosthesis, hip, femoral component, cemented, metal1 report
- REFLECTION 71358037Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent REFLECTION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) REAMER HANDLE BROKE AND PART DISASSOCIATED WHEN REAMING. NO PIECES FELL INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25573118 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) OFFSET REF CUP POS/IMPACTOR BROKE UPON IMPACTION OF THE CUP. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25343082 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) REF BALL JNT SCREWDRIVER SHAFT WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342864 ↗MalfunctionMay 25, 2026Fracture
IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE OFF DUE TO TORSION. ALL BROKEN PIECES WERE ACCOUNTED FOR AND DID NOT FALL IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273385 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) REF BALL JNT SCREWDRIVER SHAFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203657 ↗MalfunctionMay 15, 2026Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP ON ONE REF BALL JNT SCREWDRIVER SHAFT BROKE OFF, ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185578 ↗MalfunctionMay 11, 2026Fracture
IT WAS REPORTED THAT DURING A THR, THE SHAFT OF A REAMER HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136347 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT, DURING A THA, AN REAMER HANDLE SNAPPED AT THE ADAPTOR/HANDLE JUNCTION. NO PIECES WERE LOST. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776555 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT, DURING A THA SURGERY, TWO (2) REF BALL JNT SCREWDRIVER SHAFT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748122 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT DURING A THR SURGERY, THE REAMER HANDLE BROKE UPON REAMING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24724910 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED THAT, DURING A THR, ONE (1) SCREW FORCEPS BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674304 ↗MalfunctionMar 18, 2026Break
IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF THE REAMER HANDLE WAS BROKEN WHILE REAMING SOCKET. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626494 ↗InjuryMar 9, 2026Fracture
IT WAS REPORTED THAT, AFTER A REVISION HIP SURGERY HAD BEEN PERFORMED IN 2017, THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND LIMITED MOBILITY DUE TO A DISLOCATED HIP, AND IT APPEARS ON X-RAY THAT THE LOCKING RING OF THE CON LNR 0DEG 26ID 50-52OD SZ E HAS BROKEN, AND THE COCR 12/14 FEM HEAD 26 + 8 HAS MIGRATED SUPERIORLY. THE ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON, IN WHICH THE CON LNR 0DEG 26ID 50-52OD SZ E WAS REMOVED AND A CEMENTED POLARCUP WAS INSERTED INTO THE EXISTING SHELL. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Discomfort; Joint Dislocation; Loss of Range of Motion; Pain
MAUDE report 24545599 ↗MalfunctionMar 7, 2026Fracture
IT WAS REPORTED THAT DURING A THA, THE REF BALL JNT SCREWDRIVER SHAFT BROKE OFF WHEN INSERTING SCREW INTO 3 HOLE CUP. THE FRAGMENT DID FALL INTO THE PATIENT, BUT WAS REMOVED PROMPTLY BY HAND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540971 ↗MalfunctionFeb 14, 2026Malposition of Device
IT WAS REPORTED THAT, DURING A REDAPT FULLY POROUS CUP SURGERY, ONE (1) REF SPHER HEAD SCREW 30MM HAD GONE BEYOND THE SCREW HOLE AND LOWER THAN THE PETALS OF ONE (1) REDAPT FULLY POROUS SHELL 58MM, THEREFORE THE CANCELLOUS SCREW WAS REMOVED WITH SOME DIFFICULTY. SURGEON DECIDED TO NOT REPLACE THE SCREW, THEREFORE, LEAVING A VOID IN PATIENT'S BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 24341241 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page