REDAPTRecalls & reported problems across all models
Smith & Nephew, Inc. · 89 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 215
- Deaths reported
- 0
- Injuries reported
- 138
- Recalls
- 0
We found 89 models of REDAPT by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 215 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and May 1, 2026 — classified as 138 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Break” (32 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 REDAPT problems
Device problems
- Adverse Event Without Identified Device or Use Problem92
- Break32
- Fracture24
- Insufficient Device Problem Information18
- Mechanical Jam8
- Detachment of Device or Device Component7
- Contamination /Decontamination Problem4
- Device Dislodged or Dislocated4
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Unspecified Infection32
- Bone Fracture(s)19
- Injury13
- Pain12
- Failure of Implant11
- No Consequences Or Impact To Patient10
- Medical device site infection8
REDAPT models
89 models, most reported first. Each model has its own page with its reports, recalls and device details.
- REDAPT 71355107Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented26 reports
- REDAPT 71355094Prosthesis, hip, femoral component, cemented, metal25 reports
- REDAPT 71354632Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented14 reports
- REDAPT 71354631Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate9 reports
- REDAPT 71354234Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- REDAPT 71352360Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous6 reports
- REDAPT 71354709Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- REDAPT 71352356PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- REDAPT 71354805Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate4 reports
- REDAPT 71352352PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- REDAPT 71352354Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous4 reports
- REDAPT 71354703Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- REDAPT 71354708Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- REDAPT 71354865Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- REDAPT 71354465Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- REDAPT 71354483Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- REDAPT 71352362Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous3 reports
- REDAPT 71354243Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- REDAPT 71354521Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- REDAPT 71355121Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- REDAPT 71354722Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71354739Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71354807Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- REDAPT 71354822Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71354825Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- REDAPT 71354466Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71354467Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate2 reports
- REDAPT 71354482Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71354486Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71355344Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- REDAPT 71352348PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- REDAPT 71352358PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- REDAPT 71352366Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- REDAPT 71354041Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354313Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354318Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354319Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354320Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354334Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354335Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354363Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71355015Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71355051Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71355109Prosthesis, hip, femoral component, cemented, metal1 report
- REDAPT 71354427PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71354444PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71354416PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71354228Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REDAPT 71354264Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354229Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354231Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- REDAPT 71354233Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REDAPT 71354236Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REDAPT 71354238Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REDAPT 71354533PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71354543Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- REDAPT 71354298Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- REDAPT 71354704Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354706Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354707Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354711Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354713Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354723Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354724Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354738Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354742Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354743Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354746Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354757Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354758Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354802Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354806Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354808Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354824Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354829Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354843Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354844Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354846Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- REDAPT 71354855Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354858Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354464Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354468Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71355345Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71355438Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- REDAPT 71354641PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71355371PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71352364PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71352368PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- REDAPT 71354412PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent REDAPT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT TRIAL BODY SZ 12-15 OUTER SLEEVE CAME OFF DURING STANDARD USAGE. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 25062113 ↗InjuryApr 28, 2026Fracture
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON 2017, THE PATIENT EXPERIENCED THE BREAKAGE OF ONE (1) REDAPT FULLY POROUS SHELL 58MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE CUP WAS EXCHANGE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25024149 ↗MalfunctionDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT STRAIGHT SHAFT DRILL 35MM BROKE WHILE DRILLING THE ACETABULAR HOLE FOR SCREW IMPLANTATION. THE PROCEDURE WAS PERFORMED, 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 23922892 ↗MalfunctionDec 11, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR REVISION SURGERY, WHEN REMOVING THE REDAPT STEM USING THE REDAPT STEM EXTRACTOR UNIV JOINT, THE THREADED PIECE BROKE AND WAS LEFT IN THE STEM. NO PIECES FELL INSIDE THE SURGICAL SITE. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, BY REMOVING THE STEM USING A VICE GRIP AND SLAP HAMMER FROM INNOMED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782552 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL, SUSTAINED A DISLOCATION, AND WAS SUBSEQUENTLY REDUCED. THE CUP WAS FOUND TO HAVE SHIFTED VERTICALLY. THE ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, DURING WHICH IT WAS OBSERVED THAT THE LOCKING SCREW TABS WERE SEPARATED FROM THE CUP. ALL HARDWARE AND LOCKING TABS WERE SUCCESSFULLY REMOVED, AND THE CUP WAS EXCHANGED WITH A SLICE AUGMENT AND AN UPSIZED CUP. THE PATIENT¿S CURRENT HEALTH STATUS IS STABLE.
Patient problems: Joint Dislocation
MAUDE report 23461216 ↗InjurySep 10, 2025Biocompatibility; Biocompatibility
IT WAS REPORTED THAT, AFTER A THR FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION AND S+N DEVICES WERE IMPLANTED, AN ADDITIONAL REVISION SURGERY IS REQUIRED IN THE NEAR FUTURE, AS THE PATIENT IS EXPERIENCING ELEVATED METAL ION LEVELS.
Patient problems: High metal ion levels
MAUDE report 23017713 ↗MalfunctionJul 23, 2025Break; Break
IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) REDAPT STEM EXTRACTOR UNIV JOINT WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576015 ↗MalfunctionJun 11, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A REVISION THR SURGERY, A REDAPT REAMER REMOVAL CAP BROKE WHILE TRYING TO REMOVE THE REAMER. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE, THE SURGEON HAD TO PERFORM AN ETO ON THE PATIENT TO REMOVE THE REAMER. NOTHING FELL IN THE WOUND, AS THE THREADED END OF THE DISTAL REAMER BROKE OFF INSIDE THE REMOVAL CAP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185795 ↗InjuryJun 5, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT DISTAL REAMER 240MM SIZE 17 GOT STUCK WHILE REAMING. AN ETO WAS PERFORMED TO THE FEMUR TO REMOVE THE DISTAL REAMER. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: Laceration(s)
MAUDE report 22155750 ↗MalfunctionJun 3, 2025Break; Break
IT WAS REPORTED THAT, DURING THR, THREE (3) REDAPT REV ACETABULAR DRILL GUIDE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22129749 ↗MalfunctionApr 21, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, A REDPAPT STEM WAS PLACED. THE STEM WAS ABOUT 2CM PROUD. THE REDAPT STEM EXTRACTOR UNIV JOINT WAS SCREWED IN AND WHILE SLAPPING IT OUT THE TIP BROKE OFF IN THE STEM. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A COMPETITOR'S DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875772 ↗MalfunctionApr 21, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT TRIAL BODY SZ 12-15 BROKE INTO TWO PIECES WHILE SURGEON WAS EXPLAINING THE DEVICE FROM THE STEM. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21873735 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THA REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023, THE PATIENT EXPERIENCED PAIN. A I&D PROCEDURE WAS CARRIED OUT ON THE (B)(6) 2024 AND THE PATIENT WAS CONFIRMED WITH A HIP INFECTION BY MSSA. A REVISION SURGERY WAS THEN PERFORMED ON THE (B)(6) 2024, IN WHICH ANTIBIOTIC SPACERS WERE PLACED UNTIL THE (B)(6) 2024 WHEN THE PATIENT RECEIVED NEW IMPLANTS. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: Bacterial Infection; Pain
MAUDE report 21067258 ↗InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THR SURGERY ON (B)(6) 2022 THE PATIENT EXPERIENCED ACUTE BLOOD LOSS ANEMIA. THE SUBJECT LOST 500 CC AND HGB DROPPED 6.4. THIS ADVERSE EVENT WAS TREATED BY BLOOD TRANSFUSION. ALSO, THE LEG WAS BRACE FOR A WEEK. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding
MAUDE report 21018696 ↗MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN REMOVING THE TRIAL COMPONENTS WITH THE HOOK AFTER IMPACTION, THE BODY OF ONE (1) REDAPT TRIAL BODY SZ 12-15 DISCONNECTED, AND THE WAVE SPRING POPPED OUT FALLING INTO THE SURGICAL TABLE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662432 ↗
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.
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