Triathlon 5510-F-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07613327040272), received between May 11, 2017 and Dec 19, 2025 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  NO NEW INFORMATION.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 23847411 ↗
• InjuryFeb 18, 2025Unstable; Implant subsidence; Unstable; Implant subsidence

  AS REPORTED: "REVISION LEFT TOTAL KNEE. THE SURGEON REQUESTED INVESTIGATION RESULTS FROM THIS COMPLAINT BECAUSE HE SAID THE IMPLANTS HAVE BEEN IN FOR LESS THAN 5 YEARS. NO INFORMATION FROM THE INDEX SURGERY WAS PROVIDED. THE KNEE WAS NOT REVISED TO STRYKER IMPLANTS SO THE ONLY INFORMATION I HAVE FROM THE DOCTOR OR HOSPITAL IS THE PICTURES PROVIDED BELOW. THE SURGEON ALSO REQUESTED THAT THE IMPLANTS BE RETURNED TO STRYKER FOR THE INVESTIGATION." REP CONFIRMED THAT A STRYKER PATELLAR COMPONENT WAS LEFT IN SITU.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 21399686 ↗
• InjuryOct 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISED A FEMUR AND INSERT OF A LEFT KNEE DUE TO FEMORAL LOOSENING. ORIGINAL PRIMARY WAS DONE (B)(6) 2019 AND WAS REVISED TO A CEMENTED FEMUR ON (B)(6) 2023.

  Patient problems: Joint Dislocation

  MAUDE report 20501303 ↗
• InjuryMay 22, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "DURING THE FIRST CASE OF THE DAY, A CEMENTED FEMUR WAS OPENED IN PLACE OF A PRESSFIT FEMUR. CEMENTED AND PRESSFIT WERE IN THE ROOM DUE TO THE DOCTOR ASKING FOR A POSSIBLE CEMENTED TIBIA WITH STEM. CEMENTED AND PRESSFIT IMPLANTS WERE IN SEPARATE LOCATIONS DURING THE CASE. WHEN ASKED FOR IMPLANTS, I ANNOUNCED AND SHOWED THE BOXES TO MYSELF, DR. MITCHELL, HIS PA, THE SCRUB TECH AND CIRCULATING NURSE. DURING THE SECOND CASE OF THE DAY I NOTICED THAT MY INVENTORY WAS OFF FROM THE FIRST CASE. AFTER ASKING THE CIRCULATOR FOR THE SECOND CASE, IF THE PATIENT WAS STILL AT THE HOSPITAL WHICH THEY HAD ALREADY BEEN DISCHARGED, I NOTIFIED DR. MITCHELL THAT THERE WAS AN URGENT MATTER TO DISCUSS. AFTER THE IMPLANTATION OF THE SECOND CASES IMPLANTS, HE SCRUBBED OUT AND I NOTIFIED HIM THAT A CEMENTED FEMUR WAS USED IN THE FIRST CASE. THIS IS ALL THE INFORMATION THAT WILL BE RELEASED BY THE HOSPITAL AND SURGEON." MPS CONFIRMED THAT PATIENT WAS REVISED ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19368648 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT TOTAL KNEE REVISION OF FEMORAL COMPONENT AND TIBIAL BEARING INSERT DUE TO PCL LAXITY. CONVERTED CR KNEE CONSTRUCT TO A PS KNEE CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18664504 ↗
• InjuryMay 12, 2023Fracture; Fracture

  THE FOLLOWING WAS REPORTED: "REVISION OF A CRACKED BROKEN 4 LEFT CR FEMUR PUT IN 2009."

  Patient problems: Insufficient Information

  MAUDE report 16917161 ↗
• InjuryApr 3, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  PT IS INQUIRING IF PRODUCT IS SUBJECT TO RECALL. PT STATED THAT A LEFT TRIATHLON FEMORAL COMPONENT IS IMPLANTED IN HER RIGHT KNEE. PENDING REVISION, DATE TBD. PRIMARY SURGERY NOVEMBER 2018.

  Patient problems: Insufficient Information

  MAUDE report 16662743 ↗
• InjuryOct 31, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: REMOVED CEMENTED CR FEMUR AND REPLACED WITH PRESS-FIT CR FEMUR. SURGEON IMPLANTED CEMENTED FEMUR INSTEAD OF PRESS-FIT FEMUR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697876 ↗
• InjuryFeb 11, 2022Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "THE PATIENT PRESENTED COMPLAINING OF PAIN AND INSTABILITY. IT WAS FOUND IN SURGERY THAT THE FEMUR WAS NOT WELL FIXED. NO OTHER INFORMATION OR RETURNS ARE AVAILABLE FROM THE HOSPITAL OR SURGEON." SPOKE TO REP, WHO PROVIDED PRIMARY AND REVISION USAGE FOR THE PATIENT'S LEFT KNEE. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Pain

  MAUDE report 13516745 ↗
• InjuryAug 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION ON (B)(6) 2020. PATIENT IS A (B)(6)-YEAR-OLD FEMALE WHO PREVIOUSLY UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT - OUTSIDE CORS SCOPE. SHE UNDERWENT REVISION ON (B)(6) 2020 FOR PJI. PATIENT REQUIRED REIMPLANTATION WHICH WAS PERFORMED IN (B)(6) 2020. ALL COMPONENTS WHERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 12323565 ↗
• InjuryMay 26, 2021Component Incompatible; Component Incompatible

  A LEFT TRIATHLON SIZE 4 CEMENTED FEMUR WAS IMPLANTED ON A RIGHT TKR. (B)(6) 2021: PATIENT IS NOT GOING TO BE REVISED. THE PLAN IS TO MONITOR THE PATIENT. CURRENTLY SHE IS DOING WELL. HER RANGE OF MOTION IS 90 DEGREES OF FLEX ION AND EXTENSION AND SHE IS HAPPY AND PAIN FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889302 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SURGERIES (B)(6) 2021 ((B)(6) 2021 REVISION, LEFT TOTAL KNEE REPLACEMENT) AND (B)(6) 2021 (PATELLOFEMORAL REPLACEMENT, LEFT KNEE.) NO EXPLANTED COMPONENTS SPECIFIED IN PATIENT CHART FOR (B)(6) 2021 SURGERY. (NOTE: A TRIATHLON FEMORAL COMPONENT WAS REVISED TO AN AVON FEMORAL COMPONENT).

  Patient problems: Insufficient Information

  MAUDE report 11523198 ↗
• InjuryMar 2, 2021Break; Break

  BROKEN FEMUR COMPONENT. HAD TO HAVE A REVISION LEFT TOTAL KNEE.

  Patient problems: Fall; Insufficient Information; Pain

  MAUDE report 11398497 ↗
• InjuryDec 10, 2020Adverse 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 ARTHROFIBROSIS. THE LEFT TOTAL KNEE WAS CONVERTED FROM CR TO PS. REP CONFIRMED THAT EXPLANTS WILL BE RETAINED BY THE HOSPITAL.

  Patient problems: No Information

  MAUDE report 10981984 ↗
• InjuryNov 3, 2020Unstable; Unstable

  PATIENT HAS INSTABILITY IN HER LEFT KNEE. FEMUR APPEARS TO BE ABLE TO SHIFT POSTERIORLY.

  Patient problems: Joint Laxity

  MAUDE report 10781478 ↗
• InjuryNov 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "I PULLED IMPLANTS FOR OUR CASE AND HAD BOTH CEMENTED AND PRESS-FIT ON A CART AVAILABLE FOR OUR CASE. I GRABBED THE IMPLANTS AND SHOWED THE SURGEON DURING THE IMPLANT TIME OUT, WE AGREED THAT THEY WERE CORRECT AND THEY WERE OPENED. THE FEMUR THAT WAS OPENED WAS A CEMENTED IMPLANT WHEN IT WAS SUPPOSED TO BE A PRESS-FIT IMPLANT. THE IMPLANTS WERE PUT IN AND THEY CLOSED. WHEN I WENT TO PUT MY IMPLANTS AWAY AFTER THE CASE I NOTICED THAT I HAD A PRESS-FIT FEMUR ON MY CART WHEN I SHOULD HAVE HAD A CEMENTED FEMUR. I NOTIFIED STAFF AS SOON AS I REALIZED THE MISTAKE." SPOKE TO MPS. NO JR REP WAS PRESENT AS THEY WERE COVERING ANOTHER CASE. REVISION SURGERY TOOK PLACE (B)(6) 2020. MPS CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. LEFT MAKO TKA.

  Patient problems: Insufficient Information

  MAUDE report 10770226 ↗
• InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. REP REPORTED THAT THERE WERE NO OBSERVED ISSUES WITH THE EXPLANTED DEVICES. INTRA-OPERATIVELY, SURGEON CHECKED JOINT ALIGNMENT AND BALANCE AND REPORTED THAT THE IMPLANTS WERE WELL-POSITIONED. SURGEON REVISED A CR FEMORAL COMPONENT AND CS INSERT TO A PS FEMUR AND INSERT. REP PROVIDED THE PRIMARY USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain

  MAUDE report 10483796 ↗
• InjurySep 4, 2019Unstable; Unstable

  MEDICAL REVIEW IDENTIFIED 2 ADDITIONAL REVISION SURGERIES FOR INSTABILITY FOR THIS PATIENT. THIS PI IS FOR THE SECOND REVISION SURGERY WHICH TOOK PLACE ON (B)(6) 2014. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY OF LEFT TOTAL KNEE ARTHROPLASTY." MEDICAL REVIEW STATED: EARLY POSTOPERATIVE THE KNEE DID REASONABLY WELL BUT PATIENT RETURNED ALREADY ON (B)(6) 2013, WITH PERSISTENT PAIN AND POPPING SENSATIONS IN THE LEFT KNEE. UPON PHYSICAL EXAMINATION DIFFUSE INSTABILITY WAS NOTED, BOTH IN VARUS/VALGUS AS WELL AS ANTERIOR/POSTERIOR, BOTH IN EXTENSION AND FLEXION WITH HYPEREXTENSION BEING PRESENT IN THE KNEE. A DIAGNOSIS OF INSTABILITY WAS MADE WITH AN ASSUMPTION THAT THE PCL (POSTERIOR CRUCIATE LIGAMENT) WAS DAMAGED, SOMETHING THAT EXPLAINS INSTABILITY WITH A CR TYPE KNEE THAT REQUIRES AN INTACT PCL. CONVERSION TO A POSTERIOR STABILISED (PS) KNEE WAS DEEMED NECESSARY REQUIRING FEMORAL EXCHANGE BECAUSE OF THE BOX FOR THE POST/CAM MECHANISM. THIS SECOND LEFT KNEE REVISION WAS PERFORMED ON (B)(6) 2014, WITH EXCHANGE OF THE TRIATHLON CR FOR A TRIATHLON TS WITH PS BEARING INSERT. TIBIA WAS RETAINED. POSTERIOR AND DISTAL

  Patient problems: Injury; Pain

  MAUDE report 8959755 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD STATUS POST LEFT SEPTIC KNEE WITH CONCERN FOR RESIDUAL OSTEOMYELITIS (B)(6) 2017. INDEX WAS PERFORMED IN (B)(6) 2018. PATIENT UNDERWENT LEFT KNEE REVISION FOR PERIPROSTHETIC JOINT INFECTION IN (B)(6) 2019. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8821586 ↗
• InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  KNEE REPLACEMENT SURGERY ON (B)(6) 2019. CR CEMENTED FEMUR (WITHOUT CEMENT) WAS IMPLANTED INTO PATIENT WHEN THE COMPONENT SHOULD HAVE BEEN A CR BEADED/ PRESSFIT FEMUR. BOTH DOCTOR AND REP DID NOT CATCH THIS ERROR UNTIL YESTERDAY, (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8795082 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY OF LEFT TOTAL KNEE ARTHROPLASTY." UPDATE (B)(6), 2019: MEDICAL REVIEW HAS IDENTIFIED ADDITIONAL INFO: PRIMARY LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010, USING A TRIATHLON CR KNEE WITH 11-MM X3 CS INSERT ON A PRIMARY BASEPLATE. THE FIRST YEAR POSTOPERATIVE WENT REASONABLY WELL BUT PATIENT PRESENTED AGAIN TO SURGEON ON (B)(6) 2012, WITH PROGRESSIVE LEFT KNEE PAIN, A ¿WEAK KNEE¿ WITH FEELINGS OF GIVING WAY AND ¿POPPING¿ SENSATIONS. UPON PHYSICAL EXAMINATION ¿NO GROSS INSTABILITY¿ WAS REPORTED ALTHOUGH SUBTLE INSTABILITY SIGNS WERE STILL NOTED. A DECISION FOR REVISION WITH EXCHANGE OF THE BEARING WAS ESTABLISHED AND PERFORMED ON (B)(6) 2012, WITH EXCHANGE OF THE 11-MM CS BEARING FOR A 16-MM CS BEARING WHILE RETAINING FEMUR AND TIBIA. MED REVIEW ALSO IDENTIFIED 2 SUBSEQUENT REVISION OF THIS PATIENTS KNEE. THIS PI IS FOR REVISION OF THE PRIMARY IMPLANTED ON (B)(6) 2010 AND REVISED ON (B)(6) 2012.

  Patient problems: Injury

  MAUDE report 8752768 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " LEFT TOTAL KNEE ARTHROPLASTY WITH LAXITY AND PAIN".

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 8712654 ↗
• InjuryMay 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF PRIMARY TRIATHLON TOTAL KNEE, ONE YEAR POST OP DUE TO PATELLAR DISLOCATION AND TO TIBIAL SUBSIDENCE FOLLOWING TIBIAL BONE FRACTURE.

  Patient problems: Bone Fracture(s); Injury; Joint Dislocation

  MAUDE report 8588546 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IN REPORTING A REVISION OF PATIENT'S LEFT KNEE ON (B)(6) 2019, REP REPORTED THAT AFTER THE PRIMARY IMPLANTATION ON (B)(6) 2015, A DISTAL FEMORAL FRACTURE WAS ADDRESSED WITH AN ORIF PLATE. REP WAS NOT PRESENT FOR THE PROCEDURE AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8518016 ↗
• InjuryApr 11, 2019Unstable; Unstable

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

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8506483 ↗