Triathlon 5532-G-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327050738), received between Jul 2, 2019 and Jan 29, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Detachment of Device or Device Component

  NEW NEW INFORMATION.

  Patient problems: Fall

  MAUDE report 24207997 ↗
• InjuryNov 22, 2024Device Dislodged or Dislocated; 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: Joint Dislocation

  MAUDE report 20756131 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE. PATIENT WAS CALLED FOR THEIR 6Y FOLLOW-UP VIA PHONE ON 14MAR2024. FOLLOW-UP QUESTIONNAIRE (FUPQ) WAS CONDUCTED. SUBJECT ANSWERED "YES" TO QUESTION "DO YOU HAVE ANY PAIN IN YOUR KNEE THAT HAS THE STUDY KNEE REPLACEMENT?" AND ANSWERED "NO" TO QUESTION" ARE YOU SATISFIED WITH THE RESULTS OF YOUR STUDY KNEE REPLACEMENT?". PER COMMENT NOTED BY SUBJECT, "NOT TOO SATISFIED DUE TO PAIN AND STIFFNESS". PER SENIOR CLINICAL RESEARCH COORDINATOR: THEIR BASELINE IS 1/10 DISCOMFORT NORMALLY, AND THIS IS THE SOURCE OF THEIR SATISFACTION LEVEL. THEY WERE ENCOURAGED TO REACH OUT TO DOCTOR¿S OFFICE FOR AN APPOINTMENT BUT DID NOT WISH TO MAKE AN APPOINTMENT. PREVIOUS REPORTED AE (B)(6) 2019 EXCESSIVE KNEE PAIN RESOLVED ON (B)(6) 2019: "COMPLAINTS OF RIGHT KNEE CAP PAIN, VERY PAINFUL TO WALK. WORSE UP OR DOWN STEPS. ICING 15 MINS ON/OFF. ON (B)(6) 2019 NOTED RIGHT AND LEFT KNEE PAIN AFTER PARTICIPATING IN FIREMAN TRAINING DRILLS, CRAWLING ON KNEES. TRIED USING AN ELLIPTICAL TRAINER BUT PAIN WAS LIMITING ABILITY TO PARTICIPATE VERY LONG. AFTER USE OF BIOFREEZE, ICE, AND REST, PAIN HAD RETURNED TO BASELINE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19947593 ↗
• InjuryOct 29, 2022Adverse 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 INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 15697232 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "NOT SEVERE - SWELLS. I LIMP. SPORADIC, BEHIND KNEE OR BACK OF KNEE. THOUGHT IT WOULD BE NO PAIN AT ALL, SWELLS."

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14161035 ↗
• InjuryOct 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. A 4X16 PS INSERT WAS REVISED TO A 4X22 TS INSERT. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE, THE REP WHO WAS PRESENT IS NO LONGER WITH STRYKER. REPORTING REP PROVIDED USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 10668865 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A 4X16 PS INSERT WAS EXCHANGED FOR ANOTHER 4X16 PS INSERT. REP PROVIDED USAGE SHEETS FROM CURRENT AND PRIOR REVISIONS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10189275 ↗
• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED INCLUDES AN OPERATIVE REPORT FOR A REVISION OF THE PATIENT'S LEFT KNEE WITH DIAGNOSIS "FAILED REVISION LEFT KNEE ARTHROPLASTY WITH ACUTE INFECTION." A POLY SWAP WITH IRRIGATION & DEBRIDEMENT WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10152057 ↗
• InjuryJun 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED INCLUDES A REPORT OF A FOLLOW-UP VISIT ON (B)(6) 2015. NOTED IN THE REPORT: "SHE DOES HAVE SOME REDNESS AROUND THE MEDIAL ASPECT OF THE KNEE, WHICH WAS SOMEWHAT CONCERNING TO HER. UNDER STERILE TECHNIQUES, THE LEFT KNEE WAS ASPIRATED AND APPROXIMATELY 75CC OF BLOOD-TINGED SYNOVIAL FLUID WAS ASPIRATED."

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

  MAUDE report 10147700 ↗
• InjuryJun 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED INCLUDES A REPORT OF A FOLLOW-UP VISIT ON (B)(6) 2015. NOTED IN THE REPORT: "THE PATIENT PRESENTS TODAY WITH A SMALL AREA WITH SCANT DRAINAGE EVERY TWO OR THREE DAYS ON THE INFERIOR ASPECT OF HER INCISION. MOST LIKELY DUE FROM THE RETAINED STITCH WHICH IS EXPOSED. THE STITCH WAS REMOVED TODAY. UNDER STERILE TECHNIQUE, THE LEFT KNEE WAS ASPIRATED TODAY YIELDING ONLY A SMALL AMOUNT OF SEROSANGUINEOUS FLUID."

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

  MAUDE report 10147697 ↗
• InjurySep 17, 2019Unstable; Unstable

  THE DR. REVISED A TOTAL LEFT KNEE DONE BY A PREVIOUS DOCTOR IN (B)(6) 2017 DUE TO FLEXION INSTABILITY.

  Patient problems: Injury

  MAUDE report 9079588 ↗
• InjurySep 4, 2019Unstable; Unstable

  MEDICAL REVIEW PERFORMED AS PART OF A PREVIOUS REPORT IDENTIFIED 2 ADDITIONAL REVISION SURGERIES FOR INSTABILITY FOR THIS PATIENT. THIS PI IS FOR THE THIRD REVISION SURGERY WHICH TOOK PLACE ON AN UNKNOWN DATE. 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: ON (B)(6) 2019, PATIENT RETURNED TO SURGEON WITH AGAIN PROGRESSIVE KNEE PAIN WITH INSTABILITY SYMPTOMS INCLUDING POPPING SENSATIONS. UPON EXAMINATION THE KNEE WAS AGAIN NOTED AS UNSTABLE IN ALL DIRECTIONS, VARUS/VALGUS, ANTERIOR/POSTERIOR AND IN FLEXION AS WELL AS EXTENSION. A THIRD REVISION SURGERY WAS DISCUSSED AND PLANNED INCLUDING EXCHANGE OF THE POLY BEARING FOR A THICKER VERSION. NO DATE FOR THIS PROCEDURE HAS AS YET BEEN REPORTED. INSTEAD, A LETTER FROM PATIENT¿S LAWYER APPEARED WITH REQUEST FOR EXTENSIVE DOCUMENTATION.

  Patient problems: Injury; Pain

  MAUDE report 8959499 ↗
• InjuryJul 2, 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 "UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY, ALL COMPONENTS." UPDATE 14 OCTOBER 2019: AS PER MEDICAL REVIEW DATED 13 AUGUST 2019 "COMPONENT MALPOSITION OF TRIATHLON PS KNEE COMPONENTS WITH A ¿SIGNIFICANTLY ELEVATED JOINT LINE¿ HAS CONTRIBUTED TO GROSS INSTABILITY OF THE ARTHROPLASTY REQUIRING EXCHANGE OF ALL KNEE DEVICES AFTER 5-YEARS".

  Patient problems: Injury

  MAUDE report 8753785 ↗