Triathlon 5520-B-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 07613327050325), received between Jun 27, 2017 and Aug 25, 2026 — classified as 53 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unstable” (13 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Loss of Osseointegration

  Second revision TKA. Reason for revision: loosening. Outcome: all implants removed, TS femur implanted, universal baseplate implanted, TS insert implanted.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50435586 ↗
• InjuryAug 3, 2026Osseointegration Problem

  It was reported that the patient's Left knee was revised due to aseptic loosening/ debonding of the cemented tibial baseplate. A size 4 tibial baseplate and 4x11 PS insert were revised to a size 3 Universal baseplate with 50mm stem and 3x13 PS insert. Rep confirmed there were no allegations against the revised insert. Hospital disposed of the implant.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50118726 ↗
• InjuryJan 21, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: PRIMARY TKA SURGERY WAS PERFORMED ON (B)(6) 2025. REVISION SURGERY WAS PERFORMED DUE TO THE TIBIA WAS SLIGHTLY VARUS ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 24129692 ↗
• InjuryOct 1, 2025Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: REVISION OF TRITANIUM BASEPLATE, REP TO PROVIDE FURTHER DETAILS. ADDITIONAL INFORMATION PROVIDED 2/10/25: WAS THE REVISION PROCEDURE COMPLETED SUCCESSFULLY? YES. PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE (OR INDICATE ¿NONE¿ TO CONFIRM THERE WAS ABSOLUTELY NO DELAY): NO.

  Patient problems: Insufficient Information

  MAUDE report 23190719 ↗
• InjuryNov 22, 2024Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  ON (B)(6), THE PATIENT CL WAS OPERATED, A TRIATHLON TS PROSTHESIS. THE PATIENT HAD TO HAVE A REVISION OF A PRIMARY PROSTHESIS OF OURS, IMPLANTED IN THE YEAR 2021 (I LEAVE ATTACHED CERTIFICATE OF IMPLANTS OF THE INSTITUTION). THE SURGERY ENDED SUCCESSFULLY, THE TIBIAL COMPONENT AND THE RESPECTIVE INSERT WERE CHANGED. THE FEMORAL COMPONENT WAS NOT CHANGED, BECAUSE IT WAS NOT LOOSE. LAST NIGHT THE SURGEON CONTACTED US, REPORTING THAT HE HAD TO OPERATE ON THE PATIENT, DUE TO A DISLOCATION. IN THIS LAST INTERVENTION COULD NOT RESOLVE THE DISLOCATION, THE DOCTOR SAID THAT THE FEMORAL COMPONENT IS NOT THE FEMORAL COMPONENT IS NOT COMPATIBLE WITH THE INSERT, THAT IS VERY NOTICEABLE THE DIFFERENCE OF THE SIZE OF THE FEMORAL THE SIZE OF THE FEMORAL BOX, WITH THE SIZE OF THE INSERT.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 20756134 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OF TRIATHLON TKA TIBIAL IMPLANTS. DR. COMPLETING REVISION SURGERY OF EXISTING TKA IMPLANTS. REVISION DUE TO PATIENT COMPLAINT OF PAIN AND INFECTION AS PER DR.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20287872 ↗
• InjuryMar 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF RIGHT TOTAL KNEE REPLACEMENT. SURGEON'S REASON IS POLY DISSOCIATION. ISSUE NOTICED POST IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 18884450 ↗
• InjuryJul 12, 2023Fracture; Fracture

  THE FOLLOWING WAS REPORTED, "PLEASE SEE LETTER OF THE ATTORNEY TRANSLATED BELOW: "ON (B)(6) 2019, OUR CLIENT WAS ADMITTED TO THE HOSPITAL FOR INPATIENT TREATMENT AND UNDERWENT A KNEE TEP IMPLANTATION (RIGHT) DUE TO ADVANCED GONARTHROSIS. IN CONFIDENCE IN THE EXAMINATIONS AND DIAGNOSES MADE UP TO THAT POINT, THE OPERATION WAS THEN PERFORMED ON OUR CLIENT ON (B)(6) 2019, WHEREBY THE MEDICAL PRODUCT OF THE COMPANY STRYKER, MODEL TRIATHLON CS, FEMUR SIZE 4, TIBIA SIZE 4, 11MM CS INLAY WAS SELECTED AS THE PROSTHESIS AND ITS SIZE WAS DETERMINED TO BE SIZE 4. IN A LETTER DATED (B)(6) 2019, 2019, STRYKER GMBH & CO KG INFORMED ALREADY AT THAT TIME ABOUT A DEFECTIVENESS OF THE TRIATHLON FEMORALES SERIES AND RECALLED A LARGE NUMBER OF PRODUCTS ALREADY PLACED ON THE MARKET. OUR CLIENT, WHO HAD PREVIOUSLY BEEN IMPLANTED WITH A TOTAL ENDOPROSTHESIS FROM THE SERIES AFFECTED BY THE RECALL, THEN EXPERIENCED COMPLAINTS IN THE FORM OF PERSISTENT KNEE PAIN (RIGHT) AND RESTRICTED MOVEMENT OF THE RIGHT KNEE AFTER APPROXIMATELY 2.5 YEARS, STARTING IN (B)(6) 2021. OUR CLIENT THEREFORE PRESENTED TO THE JOINT PRACTICE IN (B)(6) 2021. SINCE BOTH THE PAIN AND THE MOVEMENT RESTRICTIONS IN THE RIGHT KNEE PERSIS

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

  MAUDE report 17305884 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT TOTAL KNEE REVISION. THE REASON FOR THE REVISION TODAY WAS PAIN AND INSTABILITY. AFTER REMOVING THE IMPLANTS IT WAS BELIEVED THAT THEY WERE ORIGINALLY IMPLANTED TOO TIGHT IN FLEXION WITH TOO MUCH POSTERIOR SLOPE ON THE TIBIA. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Joint Laxity

  MAUDE report 17264229 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-DISPLACED TIBIAL PLATEAU FRACTURE OCCURRED INTRAOPERATIVELY DUE TO SCLEROTIC BONE. IT WAS FIXATED WITH SCREWS AND A FLUTED STEM. IT WAS LISTED AS RESOLVED ON THE SAME DAY. LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17258521 ↗
• InjuryJun 26, 2023Loss of Osseointegration; Loss of Osseointegration

  THIS PI FOR THE LEFT KNEE - IMPENDING REVISION (B)(6) 2023; AS REPORTED BY THE PATIENT:: RIGHT KNEE: (B)(6) 2018: PRIMARY RIGHT KNEE STRYKER IMPLANT (B)(6) 2019: REVISION, RIGHT KNEE, STRYKER IMPLANT - REASON UNKNOWN POSSIBLE SECOND REVISION OF THE RIGHT KNEE, DATE TO DETERMINE -REASON UNKNOWN (B)(6) 2023: DAUGHTER CONFIRMED THAT RIGHT KNEE REVISION WILL BE IN 2-3 MONTHS. THE SURGEON WOULD LIKE TO MINIMIZE THE RISK OF BLOOD CLOTS BY WAITING TO DO THE REVISION. LEFT KNEE: (B)(6) 2020:PRIMARY LEFT KNEE STRYKER IMPLANT (B)(6) 2022: PATIENT REPORTS PAIN, A BONE SCAN WAS PERFORMED (B)(6) 2023: DR CONFIRMED THAT HER IMPLANTS ¿FELL APART.¿ LEFT KNEE REVISION REQUIRED, REVISION SCHEDULED FOR 9 MARCH 2023. DAUGHTER IS NOT SURE IF THAT IS EVEN POSSIBLE IMPLANTS FALLING APART AND WOULD LIKE IT INVESTIGATED. (B)(6) 2023: DAUGHTER CONFIRMED HER MOTHER HAD REVISION SURGERY OF THE LEFT KNEE ON (B)(6) 2023 AND SHE IS CURRENTLY EXPERIENCING INCREASED PAIN SINCE THE PROCEDURE. DAUGHTER STATED HER MOTHER'S QUALITY LIFE HAS DIMINISHED SINCE THE MULTIPLE REVISIONS. UPDATE PER OP REPORT: PATIENT WAS REVISED ON (B)(6) 2023 DUE TO PAIN AND LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17199693 ↗
• InjuryJun 15, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT SURGEON INFORMED THAT MEDIAL LAXITY AND HYPEREXTENSION WHEN PATIENT EXTEND HIS LEG DETECTED THROUGH CLINICAL FINDING UPON CLINIC APPOINTMENT. EXPLANTED DONE AND REPLACED WITH TS IMPLANTS ( REVISION SURGERY) THIS IS A FIRST REVISION SURGERY , THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020. PATIENT OUTCOME ( AS OF 25 MAY 2022) : AS THE REVISION SURGERY JUST BEEN DONE, PATIENT IS RECOVERING WELL.

  Patient problems: Joint Laxity

  MAUDE report 14700813 ↗
• InjurySep 21, 2021Unstable; Unstable

  THIS PI IS FOR REVISION SURGERY IN 2015. "IN 2015 PATIENT WAS SEEN AGAIN COMPLAINING OF PAIN AND INSTABILITY IN THE RIGHT TOTAL KNEE REPLACEMENT. ON (B)(6) 2015 SHE UNDERWENT REVISION OF THE FEMORAL AND TIBIAL COMPONENTS OF HER RIGHT TOTAL KNEE REPLACEMENT. IT IS UNCLEAR A WHY A REVISION OF THE COMPONENTS WAS PERFORMED. NO MENTION WAS MADE OF TRYING TO CORRECT THE INSTABILITY WITH ANOTHER POLYETHYLENE EXCHANGE. THE SURGEON USED COMPONENTS WITH A ROTATING PLATFORM REVISION TRAY WITH A FEMORAL SLEEVE AND ADAPTER AND THE TIBIA HAD A METAPHYSEAL SLEEVE. THE PATELLA WAS LEFT IN PLACE."

  Patient problems: Joint Laxity; Pain

  MAUDE report 12506598 ↗
• InjurySep 16, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PATIENT PRESENTED IN SEVERE VARUS DUE TO TIBIAL BASEPLATE LOOSENING. INTRA-OPERATIVELY, IT WAS NOTICED THAT THE INSERT HAD CRACKED MEDIALLY POSTERIORLY.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 12482519 ↗
• InjurySep 11, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL FAILED LEFT TOTAL KNEE ARTHROPLASTY. UPDATE FROM MED REVIEW: "REVISION LEFT TKA - FEMORAL AND TIBIAL COMPONENTS' FOR "PAINFUL, FAILED LEFT TKA WITH INADEQUATE FIXATION OF TIBIAL COMPONENT." " ...TIBIAL AND FEMORAL COMPONENTS REMOVED WITH OSTEOTOME - REVISED TO CEMENTED, MODULAR REVISION COMPONENTS. UNCOMPLICATED SURGERY - PATELLA NOT MENTIONED."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12457635 ↗
• InjuryMay 13, 2021Device Slipped; Device Slipped

  CEMENTED TIBIA APPEARS TO HAVE SUBSIDED REQUIRING A REVISION OF THE TIBIA COMPONENT ONLY. UPDATE: "THERE IS NO INFORMATION AVAILABLE REGARDING WHICH CEMENT WAS USED FOR THE PRIMARY PROCEDURE. THE INSERT EXPLANTED SHOWED NO UNUSUAL SIGNS OF WEAR. THE LOCKING MECHANISM WAS INTACT AND HAD TO BE BROKEN TO REMOVE THE INSERT.

  Patient problems: Insufficient Information

  MAUDE report 11816980 ↗
• InjuryDec 21, 2020Osseointegration Problem; Osseointegration Problem

  OBESE PATIENT (BMI 43) HAD A LEFT PRIMARY TRIATHLON PS IMPLANTED FOR OA AND THE MEDIAL SIDE ENDED UP COLLAPSING.

  Patient problems: Arthritis

  MAUDE report 11045174 ↗
• InjuryNov 5, 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 LEFT SIDED TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT AND TRIATHLON KNEE SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 SHE HAD TO UNDERGO A REVISION SURGERY DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10795185 ↗
• InjuryOct 23, 2020Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING (IT WAS NOT REPORTED TO THE REP WHICH SPECIFIC DEVICE(S) LOOSENED). A FEMORAL COMPONENT, BASEPLATE AND INSERT WERE REVISED TO A TS KNEE CONSTRUCT WITH FEMORAL AND TIBIAL AUGMENTS, AND STEMS. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10725080 ↗
• InjurySep 14, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL SUBSIDENCE. THE BASEPLATE, INSERT, AND CR FEMORAL COMPONENT WERE REVISED TO CONVERT THE PATIENT TO A TS KNEE WITH STEMS AND AUGMENTS. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 10527288 ↗
• InjuryAug 31, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT LEFT AND RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT UNDERWENT REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY. ALL COMPONENTS EXCHANGED, EXCEPT PATELLA ON (B)(6) 2020.

  Patient problems: Injury

  MAUDE report 10471892 ↗
• InjuryJun 30, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  INFORMATION RECEIVED IN FOLLOW-UP INCLUDES AN OPERATIVE REPORT FOR A RIGHT KNEE REVISION ON (B)(6) 2019. NOTED IN THE RECORDS ARE THE FOLLOWING: "...FELL IN THE BATHTUB...SHE HAD IMMEDIATE PAIN...CONTINUED TO HAVE PAIN AND DISABILITY...FOUND TO HAVE A RUPTURE PATELLAR TENDON...FAILED RIGHT TOTAL KNEE ARTHROPLASTY WITH DISLOCATION OF THE PROSTHESIS...INSTABILITY OF HER PROSTHETIC JOINT..." A SIZE 4 PRIMARY BASEPLATE (IMPLANTED (B)(6) 2009) AND A 4X11 PS INSERT (IMPLANTED (B)(6) 2018) WERE REVISED TO A SIZE 4 UNIVERSAL BASEPLATE WITH STEM AND AUGMENTS, AND A 4X13 TS INSERT.

  Patient problems: Ambulation or Postural Difficulties; Fall; Injury; Pain

  MAUDE report 10210685 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2020 AS REPORTED: "DOCTOR STATED 'DIAGNOSIS IS ARTHROFIBROSIS.' GOT LOST TO FOLLOWUP FOR 4 YEARS, AND DEVELOPED FLEXION CONTRACTURE. PATIENT WASHED OUT (B)(6) 2014, AND HAD POLY INSERT EXCHANGED. RIGHT SIDE. NOTHING WAS LOOSE OR BROKEN. GRAHM STAIN WAS NEGATIVE [FOR INFECTION]. THIS WILL BE ALL INFORMATION DUE TO HOSPITAL POLICIES." SPOKE TO REP. THE PATIENT'S PS KNEE CONSTRUCT WAS REVISED TO A TS KNEE ON (B)(6) 2020 DUE TO THE REPORTED FLEXION CONTRACTURE.

  Patient problems: Injury; Muscular Rigidity

  MAUDE report 10206163 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN WAS REPORTED TO THE REP, BUT THE IMPLANTS WERE REPORTED AS NOT BEING LOOSE. THE PATIENT'S BASEPLATE AND INSERT WERE REVISED, AND OSTEOPHYTES REMOVED.

  Patient problems: Injury; Pain

  MAUDE report 9532009 ↗
• MalfunctionOct 31, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  CUSTOMER REPORTED THAT THEY OPENED A SIZE 4 TRIATHLON PRIMARY TIBIAL BASEPLATE (ITEM CODE: 5520-B-400), BUT INSIDE IT WAS A SIZE 4 TRIATHLON UNIVERSAL BASEPLATE (ITEM CODE: 5521-B-400). THEY HAD MORE STOCK ON CONSIGNMENT SO WERE ABLE TO COMPLETE THE SURGERY SAFELY WITH THE CORRECT IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261336 ↗