Triathlon 5520-B-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613327050318), received between Jan 11, 2017 and Mar 24, 2026 — classified as 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: DURING A REVISION FOR A POLY SWAP, IT WAS DISCOVERED THAT THERE WAS A CRACK ON THE POSTEROMEDIAL TIBIAL PLATEAU. REVISION SURGERY HAS YET TO BE SCHEDULED.

  Patient problems: Periprosthetic fracture

  MAUDE report 24682023 ↗
• InjuryMar 3, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT: PATIENT DID PRIMARY TKR ON (B)(6) 2025. CAME BACK WITH AN UNSTABLE JOINT. SURGEON INFORMED THAT MCL IS RUPTURED, DECIDED TO DO A REVISION WITH MRH ON (B)(6) 2026. MRH TIBIA BASEPLATE COULDN'T COVER WELL ON THE REMAINING SURFACE DUE TO THE LONG STEM. SURGEON COMPLAINED ABOUT OUR MRH SYSTEM THAT DOESN'T ALLOW TIBIA OFFSET. PATIENT'S BONE QUALITY WAS FOUND VERY OSTEOPEROSIS AND WAS ADVISED BY SURGEON TO WALK WITH WALKING AID AFTER REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24501321 ↗
• InjuryOct 28, 2024Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A LEFT KNEE REVISION DUE TO LOOSENING AND "LIGHTING UP ON BONE SCAN". BONE SCAN SHOWED FEMUR, PATELLA AND BASEPLATE AS LOOSE. ALL DEVICES EXPLANTED. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20543629 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A PAINFUL TIBIA. A CR KNEE WAS CONVERTED TO A TS KNEE WITH CONES AND STEMS. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 20513359 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL DOWN AND FRACTURED HER KNEE. PRIMARY LTKR WAS DONE ON (B)(6) 2023. NOW BOOKING FOR LTKR REVISION ON (B)(6) 2024. UPDATE: PATIENT WAS REVISED ON (B)(6) 2024.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 19360205 ↗
• InjuryMay 18, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN FOLLOWING 2 FALLS. PRE-OPERATIVELY, SURGEON REPORTED TIBIAL FRACTURE AND BASEPLATE SUBSIDENCE. THE BASEPLATE, INSERT, AND FEMORAL COMPONENT WERE REVISED. REP CONFIRMED FEMUR WAS REVISED TO CONVERT TO A PS KNEE, AND THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT. THE PATELLAR COMPONENT WAS RETAINED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 16951359 ↗
• InjuryFeb 16, 2023Unintended Movement; Unintended Movement

  REVISED A TIBIA OF A TRIATHLON DUE TO TIBIAL SUBSIDENCE FROM POOR BONE QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 16384140 ↗
• InjuryDec 1, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO MEDIAL SUBSIDENCE OF THE TIBIAL BASEPLATE. INTRA-OPERATIVELY, IT WAS ALSO REPORTED THAT THE PATELLAR COMPONENT WAS NOT WELL-FIXED. THE BASEPLATE, PATELLA, AND INSERT WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15896288 ↗
• InjuryOct 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REP THAT SURGEON NOTIFIED ABOUT THE TKR REVISION IS NEEDED. UPDATE: REASON FOR REVISION DUE TO DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 15622121 ↗
• InjuryMar 9, 2022Loss of Osseointegration; Loss of Osseointegration

  ASEPTIC LOOSENING TOTAL RIGHT KNEE TIBIAL BASEPLATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13714978 ↗
• InjuryOct 18, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED VIA MEDWATCH REPORT 5103633: PATIENT RECEIVED A LEFT AND RIGHT STRYKER TRIATHLON TOTAL KNEE IN 2019. PATIENT COMPLAINED OF PAIN IN 2020 WHICH PROGRESSIVELY WORSENED. LEFT KNEE IMPLANT WAS REOPERATED ON (B)(6) 2021. THE INTEROPERATIVE LAB RESULTS RULED OUT ANY INFECTION. IT WAS DISCOVERED THAT THE BONE CEMENT DID NOT BOND TO THE UNDERSIDE OF THE TIBIAL COMPONENT. THE TIBIAL IMPLANT WAS GROSSLY LOOSE. THIS IS NOT SUPPOSED TO OCCUR AND I AM REPORTING. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12646612 ↗
• InjuryJul 14, 2021Unstable; Unstable

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2008 WHERE SHE WAS IMPLANTED WITH A STRYKER KNEE SYSTEM. IT IS FURTHER ALLEGED THAT THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE SURGEON NOTES THAT "EXAMINATION OF THE POLYETHYLENE LINER AFTER REMOVAL SHOWED COMPLETE WEAR OVER THE POSTERIOR ASPECTS OF BOTH MEDIAL AND LATERAL ASPECTS OF THE POLYETHYLENE LINER." UPDATED AS PER MEDICAL REVIEW , ON (B)(6) 2017 IT WAS NOTED THAT A "REVISION RIGHT TKA" WAS PERFORMED FOR A PRE- AND POST­OPERATIVE DIAGNOSIS OF "FAILED RIGHT TKA". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A 120 MINUTE TOURNIQUET TIME. THE OPERATIVE REPORT NOTES, " ... RADIOGRAPHS ... PARTIAL POSTERIOR SUBLUXATION OF FEMUR ON TIBIA ... WITH INSTABILITY ... " AND " ... POLYETHYLENE LINER ... COMPLETE WEAR OVER THE POSTERIOR ASPECTS OF BOTH MEDIAL AND LATERAL .

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 12164846 ↗
• InjuryMar 17, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO EXTREMELY LIMITED RANGE OF MOTION. A SIZE 3 BASEPLATE AND 3X11 PS INSERT WERE REVISED TO A SIZE 3 UNIVERSAL BASEPLATE WITH AUGMENTS AND STEM, AND A 3X16 TS INSERT. REP REPORTED THAT HE MAY BE ABLE TO GET THE DATE OF PRIMARY IMPLANTATION, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 11507370 ↗
• InjuryMar 12, 2021Unstable; Unstable

  REMOVAL OF PRIMARY TRIATHLON IMPLANTS DUE TO INSTABILITY AND REPLACEMENT WITH TRIATHLON TS.

  Patient problems: Joint Laxity

  MAUDE report 11474356 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2018 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH SIMPLEX HV BONE CEMENT WITH GENTAMICIN. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO ALLEGED LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10801826 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2017 THE PATIENT UNDERWENT A RIGHT SIDED TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT WITH GENTAMICIN AND TRIATHLON KNEE SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2020 SHE HAD TO UNDERGO A REVISION SURGERY DUE TO MECHANICAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10799789 ↗
• InjuryOct 30, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A MALPOSITIONED TIBIAL BASEPLATE. SURGEON REPORTED THE TIBIA WAS IN VALGUS. PATIENT'S TIBIA WAS RE-CUT AND A SIZE 3 PRIMARY BASEPLATE AND 3X9 CR INSERT WERE REVISED TO A SIZE 3 BASEPLATE WITH A 3X14 INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Insufficient Information

  MAUDE report 10761639 ↗
• InjuryOct 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE SIZE 3 BASEPLATE, SIZE 3 R CR FEMORAL COMPONENT, AND 3 X 13 CR TIBIAL INSERT WERE REVISED TO A TS KNEE. THE PATELLA WAS NOT REVISED. THE REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10720754 ↗
• InjuryMar 9, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THE PATIENT'S KNEE WAS REVISED. AS REPORTED BY REP: "LOOSE TIBIAL BASEPLATE. REPLACED TRAY WITH STEMMED COMPONENT."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9805803 ↗
• InjuryDec 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW FOR ANOTHER PI, ON (B)(6) 2014 A "1. RIGHT KNEE ARTHROSCOPY EXTENSIVE DEBRIDEMENT/ SYNOVECTOMY [...] "WAS PERFORMED FOR A POST-OPERATIVE DIAGNOSIS OF "1. RIGHT KNEE PAINFUL ... SYNOVITIS, ADHESIONS AND METAL DEBRIS " [...] THE OPERATIVE REPORT NOTES THE RIGHT KNEE "... WIDESPREAD GRAYISH DEBRIS ... COATING THE SYNOVIUM ... SOME ADHESIONS ... REMOVED WITH SHAVER ... WIDESPREAD METALLIC DEBRIS OVER THE ENTIRE SYNOVIUM ... REMOVED ... JOINT SURFACE LOOKED GOOD" [...]

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Pain; Synovitis

  MAUDE report 9520434 ↗
• InjuryDec 9, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "LOOSE TIBIAL TRAY". PATIENT'S KNEE WAS REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9437646 ↗
• InjuryNov 18, 2019Unstable; Unstable

  IT WAS REPORTED BY THE SALES REP THAT PATIENT REPORTED TO SURGEON THAT EXPERIENCE LIGAMENT LAXITY AND INSTABILITY. INITIAL PLACEMENT OF IMPLANT WAS APPROPRIATE. SURGEON TRIALLED WITH A THICKER INSERT (13, 16MM) WHICH WAS STABLE IN EXTENSION BUT TOO TIGHT IN FLEXION. HENCE, SURGEON OPTED FOR CHANGE TO COMPETITOR HINGE TO ENSURE EXTENSION-FLEXION STABILITY AND ALSO TO MAKE SURE THAT PATIENT DOES NOT GO INTO RECURVATUM (STRYKER TRIATHLON DOES NOT HAVE A HINGE). OLD TRIATHLON IMPLANT (DONE ON (B)(6) 2017) WAS RETURNED TO PATIENT.

  Patient problems: Injury

  MAUDE report 9335157 ↗
• MalfunctionNov 14, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT, DURING A TKA, OUR SALES STAFF NOTICED A SCUFF ON THE TIBIAL TRAY. A SPARE WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9322950 ↗
• InjurySep 24, 2019Mechanical Problem; Mechanical Problem

  REVISION OF TIBIAL BASEPLATE AND POLY DUE TO MOVEMENT IN POLY AND BASEPLATE FROM LOCKING MECHANISM. SEPTEMBER 3, 2019: UPDATE PER SALES REP, "IT WAS NOT AN ALL POLY. PRODUCT CODES WERE 5531-G-309 AND 5520-B-300. SPECIFIC LOT NUMBERS ARE UNKNOWN."

  Patient problems: Injury

  MAUDE report 9109217 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN PERFORMED A PRIMARY TOTAL KNEE ON PATIENT. WHILE BACK IN PACU, THE PATIENT X-RAY SHOWED THE KNEE WAS DISLOCATED AND THE PHYSICIAN BROUGHT THE PATIENT BACK AND REVISED THE KNEE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9079691 ↗