SL-PLUSRecalls & reported problems across all models
Smith & Nephew, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 1
- Injuries reported
- 45
- Recalls
- 0
We found 18 models of SL-PLUS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Sep 25, 2018 and May 22, 2025 — classified as 1 death, 45 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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 SL-PLUS problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture19
- Break18
- Loss of Osseointegration11
- Crack1
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
- Failure to Osseointegrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Inadequate Osseointegration12
- Bone Fracture(s)8
- Failure of Implant6
- Injury5
- Hip Fracture4
- Joint Dislocation4
- Unspecified Infection4
SL-PLUS models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SL-PLUS 75004612Prosthesis, hip, semi-constrained, metal/polymer, uncemented14 reports
- SL-PLUS 75002701Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 death8 reports
- SL-PLUS 75004613Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented8 reports
- SL-PLUS 75002703Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented7 reports
- SL-PLUS 75002697Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- SL-PLUS 75002705Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented5 reports
- SL-PLUS 75007309Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented4 reports
- SL-PLUS 75002756Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- SL-PLUS 75002699Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- SL-PLUS 75002707Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- SL-PLUS 75002758Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- SL-PLUS 75002695Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- SL-PLUS 75004495Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- SL-PLUS 75007255Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- SL-PLUS 75002750Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SL-PLUS 75002719Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- SL-PLUS 75004487Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- SL-PLUS 75004604Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Recent SL-PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY, A PIECE OF ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING BROACH INTO FEMUR. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. IT WAS REPORTED THAT DURING A THR SURGERY, A PIECE OF ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING THE BROACH INTO THE FEMUR. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22067999 ↗MalfunctionApr 17, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) PLUS SL MIA DBL OFFSET ADAPT. RT 60/25MM BROKE DURING THE FEMORAL BROACHING. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 21862220 ↗MalfunctionMar 5, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, THE LOCKING MECHANISM SHEARED OFF INSIDE THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM WHILE DOING INSERTION. IT IS UNKNOWN HOW SURGERY WAS PERFORMED AND IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21531814 ↗MalfunctionMar 3, 2025Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT, DURING THA SURGERY, THE PART OF THE ROD ON ONE (1) SL-PLUS STEM IMPACTOR, CRACKED WHILE IN USE AND BROKE. THE PIECE DID NOT FALL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, BUT IT IS UNKNOWN HOW, WITHOUT ANY DELAY. NO INJURIES WERE REPORTED. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505225 ↗InjuryNov 25, 2024Fracture; Fracture
IT WAS REPORTED THAT, AFTER A THR PERFORMED, AN UNKNOWN. SL-PLUS STEM BROKE. IT IS UNKNOWN WHEN AND WHERE THE IMPLANTATION WAS PERFORMED OR IF A REVISION SURGERY IS PLANNED. CURRENT STATUS OF PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 20775811 ↗MalfunctionOct 25, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE BUTTON USED TO ENGAGE THE BROACHES TO ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM SNAPPED OFF THE BROACH HANDLE UPON IMPACTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537046 ↗MalfunctionSep 26, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY, THE CONNECTION OF THE PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE WHILE IMPACTING. CARE WAS TAKEN TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. X-RAYS WERE ALWAYS USED DURING SURGERY TO ENSURE THAT NO ADDITIONAL FRAGMENTS WERE PRESENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING 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 20311452 ↗MalfunctionAug 7, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR, A SL-PLUS MIA CURVED RASP SNAPPED NEAR THE TIP WHEN PLACED UNDER FLEXION. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19934042 ↗MalfunctionJun 17, 2024Break; Break
IT WAS REPORTED THAT, DURING THR SURGERY, A BROACH HANDLE BROKE. 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 19547264 ↗MalfunctionMar 18, 2024Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) SL-PLUS MIA CURVED RASP BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18927177 ↗MalfunctionMay 26, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT, DURING A THR, THE CONNECTION SECTION ON A PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM WAS FOUND TO BE BROKEN. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO PATIENT HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17008449 ↗MalfunctionFeb 15, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF BROACH HANDLE OF ONE (1) PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM BROKE OFF WHILE BROACHING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16383549 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2008 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A FEMORAL CALCAR CRACK AND A SHAFT FRACTURE. THE PRECISE MOMENT IN SURGERY DURING WHICH THESE EVENTS TOOK PLACE IS NOT CLEAR, NOR ARE THE MEASURES TAKEN TO RESOLVE THIS COMPLICATION. THE PATIENT'S OUTCOME IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A BICON-PLUS SHELL AND THAT SUSTAINED AN INTRAOPERATIVE ADVERSE EVENT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 15563821 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2007 TO ADDRESS AVASCULAR NECROSIS AND OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A FEMORAL SHAFT PENETRATION. THE PRECISE MOMENT IN SURGERY DURING WHICH THIS EVENT TOOK PLACE IS NOT CLEAR, NOR ARE THE MEASURES TAKEN TO RESOLVE THIS COMPLICATION. THE PATIENT'S OUTCOME IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A BICON-PLUS SHELL AND THAT SUSTAINED AN INTRAOPERATIVE ADVERSE EVENT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Perforation
MAUDE report 15560519 ↗InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2006 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A FEMORAL TROCHANTERIC FRACTURE. THE PRECISE MOMENT IN SURGERY DURING WHICH THIS EVENT TOOK PLACE IS NOT CLEAR, NOR ARE THE MEASURES TAKEN TO RESOLVE THIS COMPLICATION. THE PATIENT'S OUTCOME IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A BICON-PLUS SHELL AND THAT SUSTAINED AN INTRAOPERATIVE ADVERSE EVENT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Hip Fracture
MAUDE report 15556396 ↗
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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