Triathlon 5532-G-411Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327050714), received between Mar 15, 2017 and Jan 8, 2026 — classified as 23 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A PS KNEE WAS CONVERTED TO A TS KNEE. INTRA-OPERATIVELY, IT WAS NOTED THAT THE FEMUR AND TIBIA WERE WELL-FIXED, BUT THE POST OF THE PS INSERT WAS DAMAGED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 24002507 ↗
• InjuryOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL REVIEW OF RELATED PI NOTED THAT THE PATIENT'S LEFT KNEE "INCURRED AN INFECTION REQUIRING I & D AND POLY LINER EXCHANGE".

  Patient problems: Unspecified Infection

  MAUDE report 23244489 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED "AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S RIGHT KNEE."

  Patient problems: Loss of Range of Motion

  MAUDE report 22538765 ↗
• InjuryOct 6, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "GLOBALLY UNSTABLE RIGHT KNEE." A 4X11 PS INSERT WAS REVISED TO A 4X16 PS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 17883745 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "DID A POLY SWAP. PATIENT HAD AN INFECTION IN HIS RIGHT KNEE AFTER A DENTAL PROCEDURE. NO ALLEGATIONS AGAINST THE IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE ON THIS CASE."

  Patient problems: Unspecified Infection

  MAUDE report 16551582 ↗
• InjuryApr 11, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  THIS PI IS CREATED FOR THE LEFT KNEE. IT WAS REPORTED BY STRYKER SALES REP THAT PATIENT COMPLAINED CONSISTENT PAIN AND EFFUSION IN BOTH KNEES AFTER BILATERAL MAKO TKR SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 14073715 ↗
• InjuryMar 17, 2022Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. SURGEON PERFORMED CYST REMOVAL AND EXCHANGED A 4X11 PS INSERT FOR A 4X12 PS INSERT. UPON EXPLANTATION, THE INSERT WAS SEEN TO HAVE SOME FORM OF DISCOLORATION/ CRYSTALLIZATION UNDER THE SURFACE OF THE INSERT.

  Patient problems: Cyst(s); Pain

  MAUDE report 13800899 ↗
• InjuryDec 10, 2020Unstable; Unstable

  AS REPORTED: "REVISION LTKA WITH POLY EXCHANGE FOR INSTABILITY." A TRIATHLON X3 4 X 11 LINER WAS REVISED TO THE SAME TIME SIZE 4 X 14 LINER. SPOKE TO REP, HOSPITAL RETAINED EXPLANTS AND NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 10987651 ↗
• InjuryOct 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. AS REPORTED BY REP: "PT. PRESENTED WITH A DRAINING KNEE WOUND FOLLOWING A PREVIOUS ¿WASHOUT AND LINER-EXCHANGE¿. PT¿S KNEE WAS WASHED OUT AND THE LINER EXCHANGED AS PART OF DR¿S I&D PROTOCOL." SPOKE TO REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10688277 ↗
• MalfunctionSep 25, 2020Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED BY SALE REP THAT DURING KNEE SURGERY ,SURGEON TRY TO PUSH TIBIA INSERT INTO TIBIA TRAY BUT TIBIA INSERT COULDN'T LOCKED WITH TIBIA TRAY SO THAT SURGEON DECIDED TO CHANGE TO THE NEW ONE. THE OPERATION WAS COMPLETED SUCCESSFULLY AND NO SURGICAL DELAYED.

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

  MAUDE report 10586993 ↗
• 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 10471796 ↗
• InjuryJun 29, 2020Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unstable; 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 10206456 ↗
• InjuryJun 15, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 4X11 INSERT WAS REVISED TO A 4X14 INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10152087 ↗
• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED IN A REPORT OF LEFT KNEE EFFUSION AFTER A RECENT FALL. ON (B)(6) 2013: "UNDER STERILE TECHNIQUE, HER LEFT KNEE WAS ASPIRATED FOR BLOOD-TINGED FLUID."

  Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Inflammation; Pain

  MAUDE report 10152086 ↗
• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED IN A REPORT OF A RECURRENCE OF LEFT KNEE EFFUSION AFTER A RECENT FALL. ON (B)(6) 2013: "UNDER STERILE TECHNIQUE, HER LEFT KNEE WAS ASPIRATED FOR NOW WITH SEROUS-TYPE OF FLUID, WHICH IS NO LONGER AN ACUTE BLEED. THIS IS MORE OF A SEROSANGUINOUS TYPE OF FLUID."

  Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Fall; Inflammation; Pain

  MAUDE report 10152085 ↗
• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED INCLUDES A REPORT OF A RECURRENCE OF LEFT KNEE EFFUSION AFTER A RECENT FALL. ON (B)(6) 2013: "UNDER STERILE TECHNIQUE, HER LEFT KNEE WAS ASPIRATED...SHE HAD BLOOD-TINGED FLUID."

  Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Fall; Inflammation; Pain

  MAUDE report 10152083 ↗
• InjuryDec 2, 2019Unstable; Unstable

  AS REPORTED: "LEFT REVISION TOTAL KNEE ARTHROPLASTY, POLY LINER EXCHANGE ONLY. SURGEON COMMENT: PATIENT COMPLAINT OF HYPEREXTENSION OF KNEE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."

  Patient problems: Injury

  MAUDE report 9394587 ↗
• MalfunctionSep 5, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE NURSE OPENED THE LINER, WHEN SHE LOOKED AT IT SHE NOTICED A HAIR INSIDE THE PACKAGE THAT WAS ON TOP OF THE INSERT ITSELF. I'M SENDING THE INSERT WITH THE HAIR AND PACKAGE AS IT WAS. NO HARM TO THE PATIENT. THE INSERT WAS NEVER ON THE SURGICAL FIELD. WE OPENED ANOTHER LINER AND FINISHED THE CASE. UPDATE: 1 MIN DELAY, PRIMARY KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964977 ↗
• InjuryAug 28, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. THE FEMORAL COMPONENT AND PS INSERT WERE REVISED. THE REVISED IMPLANTS WERE NOT LOOSE, BROKEN, OR WORN. PATIENT WAS REVISED TO A FEMORAL COMPONENT WITH AUGMENTS AND STEM, AND A PS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8939509 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " FAILED LEFT TOTAL KNEE REPLACEMENT, INSTABILITY AND SUSPECTED LOOSE OR MALPOSITIONED PATELLAR COMPONENT"

  Patient problems: Injury

  MAUDE report 8686917 ↗
• MalfunctionMay 9, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON NOTICED A "FRAY" ON A 4X11MM PS POLY. WE DID NOT IMPLANT IT. IT IS AVAILABLE TO SEND IN. RIGHT SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595964 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "FIRST STAGE WASH OUT / POLY SWAP TO TREAT POSSIBLE INFECTED RIGHT TOTAL KNEE".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8528034 ↗
• InjuryFeb 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. THE PATIENT'S ENTIRE PS KNEE CONSTRUCT AND A29 ASYMMETRIC PATELLA WERE EXPLANTED. UNKNOWN IF INFECTION WAS CLINICALLY CONFIRMED OR IDENTIFIED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8302178 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT PRIMARY TKA (B)(6) 2017 AND SUBSEQUENT IRRIGATION AND DEBRIDEMENT WITH LINER EXCHANGE FOR POSSIBLE INFECTION ON (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7675455 ↗
• MalfunctionFeb 20, 2018Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  AS REPORTED: "PATIENT HAD PRIMARY TOTAL KNEE ARTHROPLASTY IMPLANTING SIZE 4 X 11 PS TIBIAL BEARING INSERT INTO SIZE 4 UNIVERSAL BASEPLATE, AFTER USING TIBIAL INSERT IMPACTOR TO FULLY SEAT INSERT, NOTICED LOCKING WIRE HAD BEEN PARTIALLY DISLODGED FROM THE INSERT NOT ALLOWING INSERT TO FULLY SEAT IN BASEPLATE. DOCTOR STATED THAT HE BELIEVED FIRST INSERT WAS DEFECTIVE. DOCTOR ASKED FOR NEW INSERT WHICH WAS AVAILABLE AND IMPLANTED NEW INSERT WITHOUT ISSUE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7282501 ↗