K-15 PORKRecalls & reported problems across all models
Smith & Nephew, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 13 models of K-15 PORK by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2021 and May 15, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 K-15 PORK problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Loss of Osseointegration4
- Failure to Osseointegrate3
- Osseointegration Problem3
- Flaked2
- Implant subsidence2
- Loosening of Implant Not Related to Bone-Ingrowth1
- No Apparent Adverse Event1
Patient problems
- Inadequate Osseointegration11
- Pain5
- Joint Laxity3
- No Clinical Signs, Symptoms or Conditions3
- Discomfort2
- Insufficient Information2
- Loss of Range of Motion2
- Unspecified Infection2
K-15 PORK models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- K-15 PORK 71425325PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- K-15 PORK 71425303PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- K-15 PORK 71425304PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- K-15 PORK 71425305PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- K-15 PORK 71425307PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- K-15 PORK 71425324PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- K-15 PORK 71425327PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- K-15 PORK 71425306PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- K-15 PORK 71425308PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- K-15 PORK 71425323PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- K-15 PORK 71425326PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- K-15 PORK 74027432PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- K-15 PORK 74027438PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Recent K-15 PORK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, ON (B)(6) 2025, 17 DAYS POSTOPERATIVELY, THE PATIENT BEGAN OUTPATIENT PHYSICAL THERAPY, AND DURING HOME THERAPY PERIOD, A FALL WAS REPORTED. ON A FOLLOW-UP VISIT ON (B)(6) 2025, THE PATIENT REPORTED PERSISTENT KNEE PAIN, WHICH INCREASED WITH MOVEMENT. THE PATIENT REPORTED THAT AFTER EXPERIENCING A TWISTING INJURY TO THE KNEE SHORTLY AFTER SURGERY, HAD NOT FULLY RECOVERED. RADIOGRAPHIES SHOWED A PERIPROSTHETIC MEDIAL PROXIMAL TIBIA FRACTURE LEADING TO GROSS LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 IN WHICH THE TIBIAL COMPONENT WAS REVISED DURING THE PROCEDURE. PATIENT'S CURRENT STATUS IS NORMAL RECOVERY OF REVISION PROCEDURE.
Patient problems: Fall; Inadequate Osseointegration; Periprosthetic fracture
MAUDE report 22024944 ↗InjuryMay 7, 2025Implant subsidence; Implant subsidence
IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SINKING ASSOCIATED WITH LOOSENING OF TIBIAL BASEPLATE AND DISCOMFORT. THE SURGEON BELIEVED THAT THIS ADVERSE EVENT WAS CAUSED BY JOINT DEGENERATION DUE TO CHARCOT JOINTS. THE ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2025 IN WHICH ONE (1) POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 RT, ONE (1) JRNY II BCS FEMORAL OXIN RT SZ 7 AND ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 11MM WERE EXPLANTED AND CHANGED. THE CURRENT PATIENT'S STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Discomfort; Joint Laxity
MAUDE report 21981448 ↗InjuryApr 23, 2025Implant subsidence; Implant subsidence
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SINKING OF THE TIBIAL BASEPLATE AND DISCOMFORT. THE SURGEON BELIEVED THAT THE PATIENT'S STIFF JOINT, HAD CAUSED THE STRESS TO BE CONCENTRATED IN THE ANTERIOR TIBIA, WHICH WAS THE CAUSE OF THE SINKING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE BASEPLATE WAS EXCHANGED TO JOURNEY TIBIAL BASEPLATE SIZE 2 AND GENESIS LONG STEM 12MM×150MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Discomfort; Loss of Range of Motion
MAUDE report 21896148 ↗InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED THE FEMUR TO BE LOOSE. IT WAS ACCOMPANIED BY PAIN AND STIFFNESS. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) POROUS TIBIA BASEPLATE W/JRNY LOCK SZ4 LT WAS EXPLANTED. PATIENT IS RECOVERING FROM SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Joint Laxity; Loss of Range of Motion; Pain
MAUDE report 20833367 ↗InjuryOct 15, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED LOOSENING AND PAIN. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 LT WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "RECOVERING".
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20458283 ↗InjuryJul 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A FRACTURE OF THE MEDIAL TIBIAL PLATEAU, WHICH CAUSED ENOUGH MOTION FOR THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ3 RT DEVICE TO NOT GROW IN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE DEVICE WAS REMOVED. CURRENT HEALTH STATUS OF PATIENT AND FURTHER DETAILS ARE UNKNOWN AT THIS MOMENT.
Patient problems: Insufficient Information
MAUDE report 19850233 ↗InjuryMay 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT AFTER A TKA SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT. THIS ADVERSE EVENT WAS SOLVED BY EXPLANTING ONE (1) POROUS TIBIA BASEPLATE WJRNY LOCK SZ6 LT. NO BONE INGROWTH WAS FOUND. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 19377268 ↗InjuryFeb 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2022, ONE (1) POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 RT WAS LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE IMPLANTS WERE REMOVED AND REPLACED WITH CEMENTED REVISION KNEE IMPLANTS. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.
Patient problems: Insufficient Information
MAUDE report 18792112 ↗InjuryFeb 19, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, ONE (1) POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 LT WAS DEEMED TO BE LOOSE PER THE SURGEON. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS REMOVED AND REPLACED WITH CEMENTED REVISION COMPONENTS. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 18734931 ↗InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A LOOSENING OF THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ3 RT. THIS INCIDENT WAS DETERMINED VIA X-RAYS. A REVISION SURGERY HAS BEEN SCHEDULED BUT THE DATE STILL UNKNOWN. CURRENTLY THE PATIENT COMPLAINS OF PERSISTENT KNEE PAIN.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 17813587 ↗InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023 THREE MONTHS AFTER, THE PATIENT EXPERIENCED PERSISTENT PAIN ON THE ANTERIOR PORTION OF THE KNEE AND A LOOSENING OF THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ4 RT. THE ADVERSE EVENT WAS TREATED BY REVISION SURGERY PERFORMED ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 17813571 ↗InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A LOOSENING OF THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 LT. THIS INCIDENT WAS DETERMINED VIA X-RAYS. A REVISION SURGERY HAS BEEN SCHEDULED BUT THE DATE STILL UNKNOWN. CURRENTLY PATIENT COMPLAINS OF PERSISTENT PAIN IN KNEE.
Patient problems: Inadequate Osseointegration; Radiolucent Lines
MAUDE report 17813325 ↗InjurySep 20, 2023Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, IT WAS DETERMINED VIA X RAY THAT ONE (1) POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 LT WAS LOOSE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO SOLVE THE PROBLEM. PATIENT HEALTH STATUS IS UNKNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 17780517 ↗InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 DUE TO INSTABILITY AND PAIN. DURING THE REVISION SURGERY IT WAS FOUND THAT THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 RT DID NOT PRESENT FULLY INGROWN. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. FURTHER DETAILS ARE NOT AVAILABLE AT THIS MOMENT.
Patient problems: Failure of Implant; Inadequate Osseointegration; Joint Laxity; Pain
MAUDE report 16857670 ↗InjuryApr 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A LOOSENING FROM THE POROUS TIBIA BSEPLATE W/JRNY LOCK SZ4 RT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY IN WHICH THE DEVICE WAS EXCHANGED ON (B)(6) 2023. PATIENT STATES THAT HER RIGHT KNEE DOES OKAY.
Patient problems: Inadequate Osseointegration
MAUDE report 16735006 ↗
Other Smith & Nephew, Inc. products
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- 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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