ZUKRecalls & reported problems across all models
Smith & Nephew, Inc. · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 234
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls
- 0
We found 46 models of ZUK by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 234 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2018 and Feb 6, 2024 — classified as 58 injuries, 176 malfunctions.
The most frequently reported specific device problem is “Break” (175 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 ZUK problems
Device problems
- Break175
- Crack15
- Insufficient Device Problem Information7
- Fracture6
- Dull, Blunt5
- Material Deformation5
- Adverse Event Without Identified Device or Use Problem4
- Defective Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- No Consequences Or Impact To Patient52
- No Known Impact Or Consequence To Patient38
- No Patient Involvement28
- No Information13
- Foreign Body In Patient6
- Failure of Implant4
- Unspecified Infection4
ZUK models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ZUK 00578907100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT35 reports
- ZUK 00584102508TEMPLATE32 reports
- ZUK 00584102408TEMPLATE29 reports
- ZUK 00584102308TEMPLATE28 reports
- ZUK 00133602800ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- ZUK 00584102608TEMPLATE11 reports
- ZUK 00584102208TEMPLATE8 reports
- ZUK 00584102509TEMPLATE8 reports
- ZUK 00584102309TEMPLATE7 reports
- ZUK 00584301800INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- ZUK 00584102409TEMPLATE5 reports
- ZUK 00584302500ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- ZUK 00584305200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- ZUK 00584202408PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ZUK 00584202409PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ZUK 00584305400ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- ZUK 00584200301PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202308PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202508PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202509PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584202608PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584209308PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ZUK 00584301402Guide, surgical, instrument2 reports
- ZUK 00578904900BIT, DRILL1 report
- ZUK 00579102300ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ZUK 00579104400ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ZUK 00579107100BIT, DRILL1 report
- ZUK 00584102108TEMPLATE1 report
- ZUK 00584102209TEMPLATE1 report
- ZUK 00584102210TEMPLATE1 report
- ZUK 00584102411TEMPLATE1 report
- ZUK 00584102510TEMPLATE1 report
- ZUK 00584102609TEMPLATE1 report
- ZUK 00584200202PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584200302PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584200401PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584201401PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584201501PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584202208PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584202209PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584202609PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584209408PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ZUK 00584301301Guide, surgical, instrument1 report
- ZUK 00584303008ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ZUK 00584305100INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- ZUK 00598304900ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent ZUK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
*US LEGAL* IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY FOR INSERT REPLACEMENT ON (B)(6) 2021, HE KEPT SUFFERING FROM PAIN, SWELLING AND MILD SYNOVITIS. ON (B)(6) 2021, THE PATIENT WAS ASPIRATED PRODUCING 50 CC OF SEROSANGUINEOUS FLUID AND ON (B)(6) 2021 THE PATIENT¿S LEFT KNEE WAS ASPIRATED AGAIN PRODUCING OVER 60 CC OF DARK BLOODY FLUID. THE PATIENT CONTINUED WITH ANTI-INFLAMMATORY AND PHYSICAL THERAPY. THE PATIENT IS CURRENTLY IN A LOT OF PAIN AND CONTINUES TO HAVE SWELLING IN THE KNEE, IS UNABLE TO CLIMB STAIRS OR BEND THE KNEE VERY MUCH. THE PATIENT RECEIVED A STEROID SHOT BUT DID NOT HELP WITH THE PAIN. ON (B)(6) 2022, THE PATIENT WAS RE-EVALUATED DUE TO PERSISTENT ANTERIOR KNEE PAIN WITH GRADE 3 CHONDROSIS OF THE PF COMPARTMENT (ACCORDING TO AN MRI). THE PATIENT WAS ADVISED TO HAVE A CONVERSION OF THE LEFT UKA TO A TKA, BUT HE HAS NOT DECIDED YET.
Patient problems: Joint effusion; Pain
MAUDE report 18655606 ↗InjuryAug 22, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN UNICOMPARTMENTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2020, THE PATIENT WOKE UP AND WHEN ATTEMPTED TO GET OUT OF BED, THE KNEE LOCKED IN A BENT POSITION. AS HE ATTEMPTED TO STRAIGHTEN HIS LEG, HE HEARD A POP AND FELT SOMETHING BREAK. THE PATIENT STARTED TO PRESENT PAIN AND IT WAS CONFIRMED VIA X-RAYS THAT PART OF THE TIBIAL COMPONENT FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO SOLVE THIS ADVERSE EVENT. THE PATIENT IS STILL RECOVERING AND USING CRUTCHES.
Patient problems: Failure of Implant; Foreign Body In Patient; Pain
MAUDE report 17597160 ↗InjuryDec 8, 2022Degraded; Degraded
IT WAS REPORTED THAT AFTER 3 YEARS ONE (1) VIVACIT-E ART SURF SZ 4 8MM WAS WORN THROUGH BY THE PATIENT. THE DEVICE WAS EXPLANTED ON (B)(6) 2022, IN ADDITION TO ONE (1) ZUK UNI TIB BASE SZ 4 RM/LL AND ONE (1) ZUK UNI FEMORAL SIZE D RM/LL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 15946335 ↗InjuryJan 4, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, AN ARTICULAR SURFACE PROVISIONAL SIZE 3 8MM BROKE DURING TRIALING. IT IS UNKNOWN IF ANY DELAY OCCURRED AS A CONSEQUENCE OF THE ISSUE. SURGERY WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153207 ↗InjuryDec 29, 2021Break; Break
IT WAS REPORTED THAT, DURING SURGERY, A ARTICULAR SURFACE PROVISIONAL SIZE 3 8MM BROKE DURING TRIALING. IT IS UNKNOWN IF ANY DELAY OCCURRED AS A CONSEQUENCE OF THIS ISSUE. SURGERY WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13114998 ↗InjuryDec 14, 2021Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN UKA ON (B)(6) 2021 PERFORMED 8 YEARS AGO, WHILE GETTING OUT OF THE TRUCK, THE PATIENT FELT SOMETHING. IT WAS DETERMINED THAT THE TIB BASE SZ 3 LM/RL FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE ALL THE IMPLANTS. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Discomfort; Failure of Implant
MAUDE report 13002721 ↗MalfunctionOct 8, 2021Break; Break
IT WAS REPORTED THAT AN ARTICULAR SURFACE PROVISIONAL SZ 3 8MM TRIAL IS BROKEN IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599280 ↗MalfunctionOct 6, 2021Break; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A FEMORAL IMPACTOR WAS SCARRED/DAMAGED. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. INVESTIGATION SHOWS THAT THE FEMORAL IMPACTOR WHITE HEAD IS MISSING FROM THE DEVICE DUE TO FRACTURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12584597 ↗InjuryOct 4, 2021Break; Break
IT WAS REPORTED THAT, DURING AN UNICOMPARTMENTAL KNEE SURGERY, AN ARTICULAR SURFACE PROVISIONAL SZ 2 8MM BROKE OFF. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12569087 ↗MalfunctionSep 2, 2021Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM BROKE. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12418215 ↗MalfunctionAug 16, 2021Break; Break
IT WAS REPORTED THAT A ZUK TENSION GAUGE IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325210 ↗MalfunctionAug 16, 2021Break; Break
IT WAS REPORTED THAT A ZUK TENSION GAUGE IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12325146 ↗MalfunctionAug 4, 2021Break; Break
IT WAS REPORTED THAT, DURING A TKA, THE FEMORAL IMPACTOR TIP BROKE OFF IN HANDLE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED AND IF IT WAS DELAYED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12277285 ↗MalfunctionJul 21, 2021Crack; Crack
IT WAS REPORTED THAT AN ARTICULAR SURFACE PROVISIONAL SZ 5 8MM WAS FOUND CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12201309 ↗MalfunctionJul 5, 2021Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE FOUND BROKEN: ONE (1) GENESIS II FEMORAL IMPLANT IMPACTOR ((B)(4)), ONE (1) OR3O DUAL MOBILITY TRIAL LINER 36/48 ((B)(4)), SIXTEEN (16) TRIGEN LIDS FOR OUTER CASES ((B)(4)), SEVEN (7) TRIGEN SMALL OUTER CASES - 2.4 ((B)(4)), THREE (3) TRIGEN LARGE OUTER CASES - 4.8, ((B)(4)), ONE (1) ZUK ARTICULAR SURFACE PROVISIONAL SIZE 4 8MM ((B)(4)), AND ONE (1) JOURNEY II BCS LOCKING FEMORAL IMPLANT IMPACTOR ((B)(4)). THIS WAS NOTED AS A DAMAGE DURING SHIPPING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12114785 ↗
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