Triathlon 5530-G-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327050585), received between Feb 24, 2017 and Nov 22, 2024 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT REQUIRING REVISION SURGERY FOR TIBIAL INSERT CHANGE, AND PATELLA RESURFACING (ADDITION OF PATELLA IMPLANT).

  Patient problems: Insufficient Information; Pain

  MAUDE report 20756212 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WASHOUT/POLY EXCHANGE FOR CELLULITIS." RIGHT KNEE.

  Patient problems: Cellulitis

  MAUDE report 13521852 ↗
• InjuryNov 12, 2021Adverse 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, A 6X9 MM CR INSERT, SIZE 5 CR FEMORAL COMPONENT, SIZE 6 PRIMARY BASEPLATE, AND 39 MM SYMMETRIC PATELLA WERE REMOVED. A WASHOUT WAS DONE AND A 6X13 MM PS INSERT, SIZE 5 PS FEMORAL COMPONENT, SIZE 6 UNIVERSAL BASEPLATE, AND NEW 39 MM PATELLA WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 12804529 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERING FROM LEFT TRICOMPARTMENTAL GONARTHROSIS, OPERATED ON (B)(6) 2020 FOR IMPLANTATION OF TOTAL LEFT KNEE PROSTHESIS (TRIATHLON TRIANIUM CR) WITH MAKO ROBOTIC SYSTEM (STRYKER) ON (B)(6) 2020 POSTOPERATIVELY, THE PATIENT DEVELOPED AN ACUTE PERIPROSTHETIC INFECTION LEFT KNEE FOR WHICH SURGERY WAS REQUIRED CLEANING AND REMOVAL OF MOVING PARTS (POLYETHYLENE INSERT).

  Patient problems: Unspecified Infection

  MAUDE report 11146607 ↗
• InjuryDec 9, 2019Unstable; Unstable

  PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PAIN AND INSTABILITY. ALL AVAILABLE INFORMATION SUBMITTED." A 6X9 CR INSERT WAS REVISED TO A 6X13 CS INSERT. REP PROVIDED X-RAYS, PRIMARY OPERATIVE REPORT, AND EXPLANT PICTURE.

  Patient problems: Injury; Pain

  MAUDE report 9437536 ↗
• InjuryJul 22, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR. A LINER EXCHANGE WAS PERFORMED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8812781 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO" ONE YEAR STATUS POST CEMENTLESS LEFT TOTAL KNEE ARTHROPLASTY WITH ANTERIOR-POSTERIOR INSTABILITY."

  Patient problems: Injury

  MAUDE report 8755078 ↗
• InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A RANGE OF MOTION ISSUE (PATIENT COULD NOT FULLY EXTEND THE KNEE). THE TIBIAL INSERT WAS SWAPPED FOR A DEVICE OF THE SAME CATALOG NUMBER (DIFFERENT LOT). NO ALLEGATIONS WERE REPORTED TO THE REP AGAINST THE REVISED DEVICE. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8735874 ↗
• MalfunctionJun 24, 2019Difficult to Insert; Difficult to Insert

  UPON IMPLANTING THE INSERT, IT WAS NOTED THE LATERAL SIDE DID NOT ENGAGE INTO THE TIBIAL BASE PLATE ANTERIORLY. IT WAS ASSUMED THE WIRE BENT ON INSERTION AND WOULD NOT SINK BELOW THE LEVEL OF THE LOCKING TAB. THE IMPLANT WAS REMOVED AND ANOTHER REPLACED WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8728262 ↗
• InjuryMay 29, 2019Unstable; Unstable

  IT WAS REPORTED: "PAIN AND STABILITY COMPLAINTS. ALL INFORMATION AVAILABLE HAS BEEN SUBMITTED".

  Patient problems: Injury; Pain

  MAUDE report 8650203 ↗
• MalfunctionMay 7, 2019Difficult to Insert; Difficult to Insert

  SURGEON CEMENTED CR TRIATHLON FEMUR AND TIBIA INTO PATIENT. USED A TRIAL CR LINER TO CEMENT WITH. THEN INSERTED THE REAL POLY, BUT DIDN'T ENGAGE THE BACK OF THE LINER BEFORE IMPACTING IT IN. POLY WAS THEN NOT INSERTED CORRECTLY. HAD TO REMOVE THE POLY, WHICH RUINED THE WIRE AND REQUIRED US TO OPEN ANOTHER POLY CR INSERT. WE HAD ANOTHER POLY, SO PATIENT WAS UNAFFECTED BY THIS. SURGEON IDENTIFIED THAT THE POLY WASN'T LOCKED IN AT THE BACK. SURGEON AGREED THIS WAS A SURGEON ERROR. ITEM WAS THROWN AWAY AS IT WAS NOT KNOWN THAT IT COULD/ SHOULD BE RETURNED UNTIL REP SPOKE TO RM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588325 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. INFECTING MICROORGANISM WAS NOT REPORTED TO THE REP, BUT THE SURGEON REPORTED PATIENT'S EXISTING BLADDER INFECTION AS THE CAUSE. PATIENT'S ENTIRE CR CONSTRUCT INCLUDING PATELLA WERE REVISED TO ANOTHER STRYKER KNEE CONSTRUCT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8565637 ↗
• MalfunctionDec 28, 2018Break; Break

  THE CUSTOMER REPORTED "INSERT LOCKING WIRE". AS PER ADDITIONAL INFORMATION RECEIVED: BREAKAGE OF INSERT LOCKING WIRE. CUSTOMER HAS CONFIRMED THAT PATIENTS DIDN¿T SUFFER ANY INJURY REGARDING THE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203756 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO MECHANICAL COMPLICATIONS. SURGEON WOULD NOT ELABORATE ON THE MECHANICAL COMPLICATIONS BUT EMPHATICALLY RULED OUT THE DEVICES HAVING CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED TO A TRIATHLON TS CONSTRUCT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 7742581 ↗
• MalfunctionFeb 24, 2017Component Missing; Mechanics Altered; Component Missing

  INSERT WOULD NOT LOCK INTO BASEPLATE AFTER REPEATED TRIES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6356921 ↗