Triathlon 5530-G-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07613327050479), received between Apr 10, 2017 and Sep 26, 2022 — classified as 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PATIENT UNABLE TO FULLY FLEX KNEE. TRIATHLON INSERT EXCHANGED

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15483765 ↗
• InjuryJun 25, 2021Fracture; Fracture

  IT WAS REPORTED THE SURGEON REVISED A BROKEN TRIATHLON TIBIAL INSERT WHICH HAD BEEN IMPLANTED 8 YEARS EARLIER.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12072007 ↗
• InjuryMay 19, 2021Fracture; Fracture

  A TRIATHLON KNEE REPLACEMENT WAS REVISED ON (B)(6) 2021 DUE TO A DAMAGED POLYETHYLENE LINER. PATIENT COMPLAINED TO SURGEON OF CLICKING, PAIN AND INSTABILITY, WHO THEN PERFORMED A REVISION PROCEDURE. THE PRIMARY KNEE REPLACEMENT WAS PERFORMED ON (B)(6)2012. THE LINER WAS FOUND TO BE CRACKED LATERALLY AND POSTERIORLY WITH MULTIPLE PIECES MISSING FROM THE POSTERIOR ASPECT OF THE LATERAL ARTICULATING SURFACE. THIS WAS REMOVED ON (B)(6) 2021 AND REPLACED WITH A NEW POLYETHYLENE LINER.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11847349 ↗
• InjuryFeb 15, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 CR INSERT WAS SWAPPED FOR A 4X13 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11327979 ↗
• InjuryNov 25, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY CAUSED BY A TORN PCL. A 4X9 CR INSERT WAS REVISED TO A 4X12 INSERT. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10905533 ↗
• InjuryJun 19, 2020Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  AS REPORTED: "EVENT INCLUDED IN THE REPORTED SUBMITTED AS PROOF OF MILESTONE FOR AN INVESTIGATOR INITIATED STUDY (B)(4). PER THE REPORT RECEIVED 31/MARCH/2020, INDICATION FOR REVISION IS PAIN AND LOOSENING; TIBIAL LINER AND TIBIAL BASEPLATE REVISED." UPDATE 02/JUNE/2020: OPERATIVE REPORT AND EXAM NOTES PROVIDED BY STUDY SITE REPORT THE FOLLOWING: "IN LATE 2012, SHE HAD A FALL. THIS DID RESULT IN SOME INCREASING RIGHT KNEE PAIN. RECENT X-RAYS HAVE SHOWN THAT SHE HAS LATERAL SUBLUXATION AND BONY EROSION AS A RESULT OF THE WEAR OF HER PATELLA AGAINST THE FEMORAL COMPONENT...FAILED RIGHT KNEE ARTHROPLASTY WITH FEMORAL COMPONENT LOOSENING AND POLYETHYLENE WEAR...THE PATIENT'S PATELLAR COMPONENT WAS COMPLETELY FLOATING IN THE KNEE...THE TIBIAL COMPONENT WAS WELL ALIGNED. THE FEMORAL COMPONENT WAS WELL ALIGNED..." IMPLANT RECORD SHOWS THAT THE PATIENT'S LINER AND PATELLAR COMPONENT WERE REVISED. NEITHER THE TIBIAL COMPONENT OR THE FEMORAL COMPONENT WERE REVISED.

  Patient problems: Fall; Injury; Pain

  MAUDE report 10173255 ↗
• InjuryJan 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MY MOTHER IS (B)(6) RIGHT NOW. SHE HAD A TOTAL KNEE REPLACEMENT IN 2013. THE 6 YEARS SHE HAS NOT BEEN ABLE TO WALK PROPERLY, HAD SEVERE PAIN, AND INVOLVED I FACTION. FINALLY HER DR. REMOVED A MASS AND AFTER THE INFECTION WOULDN¿T GO AWAY THEY TOOK THE KNEE REPLACEMENT OUT AND FOUND THE INSERT HAD BEEN DEFECTIVE. THIS IS COMPLETELY UNACCEPTABLE. IT IS A 5530-G-409.

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

  MAUDE report 9566320 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REMOVED CR SIZE4 9MM TIBIAL INSERT AND REPLACES IT WITH A CS SIZE 4 11MM TIBIAL INSERT. PATELLA WAS ALSO IMPLANTED. PATIENT HAD BEEN COMPLAINING OF WEAKNESS. XRAYS AND PRODUCT LABELS ATTACHED IN PHOTOS. PRIMARY SURGERY WAS A RIGHT KNEE REPLACEMENT DONE BY (B)(6) ON (B)(6) 2019.

  Patient problems: Injury; Weakness

  MAUDE report 9347933 ↗
• InjuryOct 7, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  REVISION ASEPTIC LOOSENING.

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

  MAUDE report 9163184 ↗
• InjuryAug 9, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT KNEE CORONAL PLANE INSTABILITY.

  Patient problems: Injury

  MAUDE report 8879984 ↗
• InjuryAug 7, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY (POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY NOT REPORTED TO REP). A 4X9 INSERT WAS EXCHANGED FOR A 4X13 CS INSERT.

  Patient problems: Injury

  MAUDE report 8869535 ↗
• InjuryJul 2, 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 "PAINFUL FAILED LEFT TOTAL KNEE ARTHROPLASTY."

  Patient problems: Injury; Pain

  MAUDE report 8752403 ↗
• InjuryJun 20, 2019Mechanical Problem; Unstable; Mechanical Problem; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "MECHANICAL FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury

  MAUDE report 8717114 ↗
• InjuryMay 22, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8631556 ↗
• InjuryMay 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A RUPTURED PCL. POSSIBLE CAUSE OR CONTRIBUTOR FOR THE RUPTURE WAS NOT REPORTED TO THE REP BUT THERE ARE NO ALLEGATIONS AGAINST THE STRYKER CONSTRUCT. THE LINER AND FEMORAL COMPONENT WERE REVISED TO TS COMPONENTS. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8616964 ↗
• InjuryMay 9, 2019Unstable; Unstable

  PATIENT HAD A TOTAL KNEE REPLACEMENT (B)(6) 2017 BY A DIFFERENT SURGEON AT ANOTHER FACILITY. PATIENT SUBSEQUENTLY HAD A FALL AND SUFFERED AN INFRAPATELLAR FRACTURE. PATIENT WAS TREATED CONSERVATIVELY IN A BRACE. PATIENT THEN COMPLAINED OF INSTABILITY. PATIENT CAME FOR FOLLOW UP FOR EVALUATION. IT WAS DETERMINED THAT PATIENT HAD INSTABILITY. PATIENT WAS SCHEDULED FOR REVISION. PATIENT WAS REVISED FROM A 9MM INSERT TO A 16. PATIENT WAS STABLE AND BALANCED. PATIENT HAS A HIGH BMI, COPD AND DIABETES. SURGEON THOUGHT THAT SHE HAD TORN HER PCL IN HER FALL AND CREATED HER INSTABILITY.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 8594753 ↗
• InjuryMay 1, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LAXITY TO RIGHT TOTAL KNEE." *UPDATE ON (B)(6) 2021: THIS PI IS FOR REVISION SURGERY IN 2013. "[...] ON (B)(6) 2013 WITH A PREOPERATIVE DIAGNOSIS OF LAXITY TO RIGHT TOTAL KNEE. THE PROCEDURE WAS A REVISION OF THE POLYETHYLENE INSERT. SURGEON REMOVED THE 9 MM INSERT AND PUT IN AN 11 MM. "

  Patient problems: Injury; Joint Laxity; Pain

  MAUDE report 8568697 ↗
• InjuryApr 11, 2019Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT TOTAL KNEE ARTHROPLASTY FAILURE WITH POLYETHYLENE WEAR, OSTEOLYSIS, AND ANTERIOR TO POSTERIOR INSTABILITY".

  Patient problems: Injury; Osteolysis

  MAUDE report 8505340 ↗
• InjuryApr 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT KNEE WASHOUT & POLY INSERT EXCHANGE FOR INFECTION (B)(6) 2019. HISTORY: RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2014. RIGHT PATELLA RESURFACING (B)(6) 2017. PATIENT FELL ONTO RIGHT KNEE AROUND (B)(6) 2019. PRESENTED WITH DAMAGED QUADRICEPS SURGERY TO REPAIR (B)(6) 2019. AT THIS SURGERY INFECTION NOTED. SPECIMENS SENT TO PATHOLOGY FOR ANALYSIS. (B)(6) GROWN.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8482338 ↗
• InjuryMar 14, 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 "INSTABILITY, RIGHT TOTAL KNEE ARTHORPLASTY".

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8421654 ↗
• InjuryOct 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. REVISION COMPONENTS WERE A SIZE 4 CR FEMUR AND 4X8 CS ALL POLY TIBIA.

  Patient problems: Injury

  MAUDE report 7997012 ↗
• InjuryOct 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO PAIN. A PATELLAR IMPLANT AND INSERT WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 7991385 ↗
• InjuryOct 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A PRIMARY TOTAL KNEE (B)(6) 2018. HE DID WELL UNTIL THIS WEEK. HE SHOWED UP FOR FOLLOW UP THIS WEEK WITH WOUND ISSUES AND AN INFECTION. PATIENT IS DIABETIC AND HAS SEVERAL COMORBIDITIES INCLUDING RENAL FAILURE, CIRRHOSIS, HYPERTENSION, ATRIAL FIBRILLATION, PREVIOUS MYOCARDIAL INFARCTION ETC. THE SURGEON ALLEGES NO ISSUES WITH THE IMPLANTS AND BELIEVES THE PATIENT GENERAL HEALTH ISSUES CONTRIBUTED TO THE INFECTION.

  Patient problems: Atrial Fibrillation; High Blood Pressure/ Hypertension; Injury; Renal Failure; Unspecified Infection

  MAUDE report 7944550 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT FELL AND HAS PAIN. SURGEON REMOVED PRIMARY TRIATHLON AND IMPLANTED TRIATHLON TS. STABLE KNEE. NO COMPLICATIONS.

  Patient problems: Fall; Injury; Pain

  MAUDE report 7860743 ↗
• MalfunctionJun 28, 2018Material Discolored; Material Discolored

  I GOT A TRIATHLON X3 TIBIAL BEARING INSERT CR SIZE 4 9MM OFF THE RACK IN THEATRE AND NOTICED THERE WAS A BROWN/ORANGE MARK ON THE OUTSIDE OF THE CARDBOARD BOX (BUT UNDER THE EXTERNAL PLASTIC BOX WRAP). WHEN THE SCOUT NURSE TOOK THE IMPLANT OUT OF THE CARDBOARD BOX I INSPECTED THE INSIDE OF THE CARDBOARD BOX. THERE WERE NO MARKINGS. THE SCRUB NURSE OPENED THE STERILE PACKAGING BUT DID NOT TOUCH THE IMPLANT. I WAS NOT SURE THAT THE IMPLANT WOULD BE STERILE SO THE IMPLANT WAS NOT IMPLANTED AND ANOTHER IDENTICAL IMPLANT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645760 ↗