Triathlon 5510-F-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327040296), received between Apr 23, 2018 and Sep 9, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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, 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING (CAUSE OR CONTRIBUTOR FOR LOOSENING NOT REPORTED). THE FEMORAL COMPONENT AND INSERT WERE REVISED (NO ALLEGATIONS AGAINST THE REVISED INSERT). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23000680 ↗
• InjuryMar 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED BECAUSE THE KNEE WAS IN VARUS. A TRIATHLON PS KNEE WAS REVISED TO A TRIATHLON TS KNEE WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 18957855 ↗
• InjuryMar 31, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 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) 23 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 16653541 ↗
• InjuryAug 10, 2022Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  PATIENT'S WIFE REPORTED HER HUSBAND HAD A PRIMARY LEFT KNEE ARTHROPLASTY ON (B)(6) 2021 AND IS SCHEDULED FOR A REVISION SURGERY ON AUGUST 1, 2022. IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING CONSTANT PAIN AND SWELLING AND FEELING OF "LOOSENING". AUDIBLE NOISE WAS ALSO REPORTED. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15203152 ↗
• InjuryJan 17, 2022Fracture; Fracture

  AS REPORTED: "WE NOTICED THE FEMUR PRIMARY (MEDIAL) CONDYLE WAS BROKEN. DR. THEN EXPLANTED THE PRIMARY COMPONENTS AND REPLACED WITH STRYKER TRIATHLON TS REVISION KNEE." SPOKE TO REP. THE PATIENT'S LEFT KNEE WAS CONVERTED FROM A CS TO A TS CONSTRUCT. ALL COMPONENTS WERE REVISED. DUE TO THE BROKEN IMPLANT, THE LINER WAS DAMAGED IN SITU. THE PATELLAR COMPONENT AND BASEPLATE WERE REVISED IN ORDER TO CONVERT THE KNEE, THERE ARE NO ALLEGATIONS AGAINST THOSE IMPLANTS.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13266129 ↗
• InjurySep 9, 2021Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Unintended Movement; Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Unintended Movement

  IT WAS REPORTED THAT; AFTER REVISION SURGERY, PATIENT STATES THAT HE CONTINUES TO EXPERIENCE PAIN AND SWELLING ON LEFT KNEE. PATIENT HAS HAD BONE SCANS AND IS CURRENTLY FOLLOWING UP WITH SURGEON AS HE STATES HIS KNEE FEELS LOOSE. *UPDATE ON 16-AUG-2021: THIS PI IS FOR THE SECOND REVISION ON (B)(6) 2013. PER MEDICAL REVIEW, "THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2013 WITH A DIAGNOSIS OF A PAINFUL UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. AT SURGERY THEY FOUND THAT THE FEMORAL COMPONENT WAS SLIGHTLY ELEVATED ANTERIORLY AND MAY HAVE RESULTED IN NARROWING THE PATELLOFEMORAL SPACE. THEY REMOVED THE FEMORAL COMPONENT THERE WAS SOME BONE LOSS LATERALLY AND ANTERIORLY AND POSTERIORLY, THEY FOUND ON THE MEDIAL SIDE THE POSTERIOR CONDYLE HAD NOT BEEN FULLY RESECTED AND THEY DOWNSIZED TO A SIZE 4. THE TIBIAL COMPONENT WAS ALSO LOOSE. THE PATELLA HAD A SCRATCH ON IT AND THEY REMOVED IT. THEY THEN CEMENTED A TRIATHLON SIZE 4 UNIVERSAL BASE PLATE AND CEMENTED A TRIATHLON X3 SYMMETRICAL 9 MM THICK PATELLA. THEY USED A SIZE 4 ¿ 16MM TOTAL STABILIZED POLY INSERT. "

  Patient problems: Inadequate Osseointegration; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12444878 ↗
• InjuryOct 30, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SURGEON SELECTED NEEDED IMPLANTS AFTER TRIALING. I SELECTED IMPLANTS OFF THE KNEE IMPLANT CART. THERE WAS A CEMENTED FEMUR IMPLANT ON THE CART WHERE THE CORRESPONDING CEMENTLESS IMPLANT WAS DESIGNATED. ALL IMPLANTS WERE SHOWN TO THE CIRCULATOR AND SURGEON PRIOR TO BEING PLACED ON THE FIELD. CEMENTED FEMUR WAS IMPLANTED, RATHER THAN THE INTENDED CEMENTLESS IMPLANT. THE PATIENT WAS BROUGHT BACK INTO THE ROOM, AND THE CEMENTED IMPLANT WAS REMOVED AND REPLACED WITH THE PROPER CEMENTLESS IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10761646 ↗
• InjuryMay 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. THE ORIGINAL SURGICAL PLAN WAS TO PERFORM A POLY EXCHANGE. INTRA-OPERATIVELY, THE MEDIAL CONDYLE OF THE FEMORAL COMPONENT WAS FOUND TO HAVE BROKEN OFF OF THE IMPLANT. THE POLY, WHICH HAD METAL EMBEDDED INTO IT, WAS ALSO FOUND TO HAVE HAD SOME WEAR MEDIALLY. PATIENT WAS REVISED TO A PS FEMORAL COMPONENT WITH A TS INSERT.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 10101239 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DURING MEDICAL REVIEW, IT WAS NOTED THAT A FURTHER EVENT WHEREBY THE LEFT KNEE WAS INVOLVED IN A PERIPROSTHETIC FRACTURE TOOK PLACE ON THE (B)(6) 2016, THIS PI IS FOR THAT EVENT.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9261814 ↗
• InjuryAug 9, 2019Unstable; Unstable

  THIS PI IS FOR THE LEFT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT AND LEFT KNEE POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WITH INSTABILITY.

  Patient problems: Injury

  MAUDE report 8879981 ↗
• InjuryJun 21, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " LOOSE LEFT TOTAL KNEE".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8721887 ↗
• InjuryMar 29, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHEN WALKING AFTER SURGERY. PATIENT STATES KNEE WAS LOOSE AND THEREFORE REQUIRED A REVISION SURGERY IN (B)(6) 2011. UPDATE: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO "PAINFUL LEFT TOTAL KNEE ARTHROPLASTY WITH ADHESIONS AND MILD SIDE-TO-SIDE LAXITY."

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury

  MAUDE report 8466811 ↗
• InjuryOct 22, 2018Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED : "FEMORAL COMPONENT AND INSERT WERE REMOVED. TS FEMUR, TWO DISTAL 10MM AUGMENTS, 15MMX100MM CEMENTED STEM, AND A 5X11 TS INSERT WERE IMPLANTED. SIZE 5X19 CR INSERT AND SIZE 5 CR FEMUR WERE EXPLANTED". UPDATE 04-OCTOBER-2018: REP REPORTED THE REASON FOR REVISION IS INSTABILITY.

  Patient problems: Injury

  MAUDE report 7991220 ↗
• InjuryOct 8, 2018Osseointegration Problem; No Apparent Adverse Event; Osseointegration Problem; No Apparent Adverse Event

  PATIENT CALLED STATING SHE HAD A LEFT KNEE REPLACEMENT ABOUT A YEAR AGO. FEW MONTHS AFTER IMPLANTATION SHE STARTED EXPERIENCING LOOSENING AND DIFFICULTY WALKING. PATIENT WAS REVISED TO COMPETITIVE DEVICES ON (B)(6) 2018. PATIENT IS SEEKING COMPENSATION. UPDATE PER MEDICAL REVIEW: PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018 (COMPETITOR DEVICES), NOT A LEFT KNEE REVISION. THIS PI TO COVER "LOOSENING & DIFFICULTY WALKING" WITHOUT REVISION.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 7944484 ↗
• InjurySep 18, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON ORIGINALLY BELIEVED THE TIBIAL BASEPLATE WAS LOOSE. ACCORDING TO THE OPERATIVE NOTE SUPPLIED BY THE REP, THE BASEPLATE WAS FOUND NOT TO BE LOOSE, BUT THE FEMORAL COMPONENT WAS SUSPECTED TO BE LOOSE. THE FEMORAL COMPONENT (IMPLANTED 2016) AND INSERT (IMPLANTED 2017) WERE REVISED TO A PS FEMORAL COMPONENT AND A TS INSERT. REP PROVIDED IMPLANT SHEETS AND OPERATIVE REPORTS FOR ALL SURGERIES AND PRE-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY. ON 27AUG2018 UPDATE AS PER MEDICAL REVIEW RECEIVED: FEMORAL COMPONENT MALPOSITION.

  Patient problems: Injury; Pain

  MAUDE report 7887362 ↗
• InjuryAug 21, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISED TOTAL KNEE FOR INFECTION AND LOOSE COMPONENTS. TIBIA AND FEMUR WERE LOOSE. INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED. FURTHER INFORMATION WILL NOT BE PROVIDED BY THE SURGEON OR HOSPITAL.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 7801483 ↗
• MalfunctionJul 24, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED VIA VOICEMAIL THAT DURING A PROCEDURE, THE PACKAGING OF A SIZE 7 CR FEMUR WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715020 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT BILATERAL TKA AND RETURNED COMPLAINING OF PAIN AND REDUCED ABILITY TO AMBULATE. PATIENT UNDERWENT LEFT KNEE REVISION TKA FOR INSTABILITY. FEMUR AND POLY EXCHANGED

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7675732 ↗
• InjuryJul 3, 2018Off-Label Use; Off-Label Use

  REPLACED FEMORAL COMPONENT. UPDATE 06-07-2018: AS REPORTED BY REP: "REASON FOR REVISION IS IT WAS DISCOVERED AFTER THE PATIENT LEFT THE ROOM THAT THE FEMORAL IMPLANT THAT WAS PRESS FIT IN PLACE WAS A CEMENTED FEMUR." UPDATE 11JUN2018: AS REPORTED BY REP: REASON FOR EVENT WAS HUMAN ERROR.

  Patient problems: Injury

  MAUDE report 7658941 ↗
• MalfunctionApr 23, 2018Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, LEFT TOTAL KNEE. IT WAS REPORTED THAT UPON OPENING THE FEMORAL COMPONENT, THE PLASTIC TRAY OF THE OUTER STERILE PACKAGE BROKE FREE WHEN THE TYVEK WAS PEELED BACK. THE INNER STERILE PACKAGING WAS INSPECTED AND DEEMED INTACT, SO THE IMPLANT WAS USED WITH NO SURGICAL DELAY. REP RETAINED THE OUTER STERILE PACKAGING ONLY (NO UDI NUMBER AS THE OUTER PACKAGING WAS DISPOSED AND NO PICTURES TAKEN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451445 ↗