Triathlon 5550-G-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327014778), received between Jul 25, 2017 and Jan 30, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Degraded; Off-Label Use

  LEFT MEDIAL UNI TO TOTAL KNEE REVISION WITH PATELLA AND POLY WEAR AND BROKEN PIECES.

  Patient problems: Insufficient Information

  MAUDE report 24222437 ↗
• InjuryJun 29, 2020Unstable; Loss of Osseointegration; Osseointegration Problem; Unstable; Loss of Osseointegration; Osseointegration Problem

  INFORMATION RECEIVED IN FOLLOW-UP INCLUDES AN OPERATIVE REPORT FOR A RIGHT KNEE REVISION ON (B)(6) 2018. NOTED IN THE RECORDS ARE THE FOLLOWING: "...HAD A FALL. SHE IS NOW HAVING SYMPTOMS OF PAIN AND PRESENTED TODAY FOR OPERATIVE INTERVENTION...FAILED RIGHT KNEE ARTHROPLASTY WITH PATELLAR LOOSENING, INSTABILITY, AND EXTENSOR MECHANISM COMPROMISE...THE PATIENT'S PATELLAR COMPONENT WAS GROSSLY LOOSE AND FREE-FLOATING..." A CR FEMUR, CS INSERT, AND TRIATHLON PATELLA WERE REVISED TO A TS FEMORAL COMPONENT WITH A STEM AND 4 AUGMENTS, A PS INSERT, AND A COMPETITOR PATELLA.

  Patient problems: Ambulation or Postural Difficulties; Fall; Injury; Pain

  MAUDE report 10206337 ↗
• InjuryJun 15, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  INFORMATION RECEIVED IN FOLLOW-UP INCLUDES AN OPERATIVE REPORT FOR A REVISION SURGERY PERFORMED (B)(6) 2010. A SYNOVECTOMY AND REMOVAL OF A LOOSE PATELLAR COMPONENT WAS PERFORMED. A NEW PATELLA WAS NOT IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 10152056 ↗
• InjuryMar 25, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO "RIGHT TOTAL KNEE REPLACEMENT INSTABILITY."

  Patient problems: Injury

  MAUDE report 8449158 ↗
• InjurySep 18, 2018Break; Osseointegration Problem; Break; Osseointegration Problem

  PATIENT HAD HIS KNEE REVISED FOR LAXITY AND PATELLA LOOSENING. THE EXPLANTED PATELLA WAS MISSING ITS PEGS AND THERE WAS NO CEMENT ATTACHED TO THE IMPLANT. THERE WERE CHUNKS OF COBALT CEMENT IN THE JOINT SPACE. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED WITH A UNIVERSAL BASEPLATE AND TS POLY INSERT. THE PS FEMORAL COMPONENT WAS RETAINED. THE PATELLA WAS RESECTED AGAIN AND REPLACED WITH A 36MM X3 SYMMETRIC PATELLA. UPDATE (B)(6) 2018: IT WAS REPORTED THROUGH MEDWACTH MW5079401 "THE PT HAD A KNEE REPLACEMENT ON 2013. HE HAD A REVISION SURGERY ON 2018 WHERE IT WAS DISCOVERED THE PATELLA BUTTON HAD FRACTURED AT ITS PEGS. THE VENDOR REP WAS IN THE REVISION SURGERY"

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7884590 ↗
• InjurySep 17, 2018Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO AN ASEPTICALLY LOOSE PATELLA. INTRA-OPERATIVELY, THE PEGS OF THE PATELLAR DEVICE WERE FOUND TO HAVE SHEARED OFF AND REMAINED IN THE CEMENT AND BONE. PATIENT DID NOT REPORT ANY FALL OR TRAUMA AND THE SURGEON HAD NO THEORY AS TO HOW THE IMPLANT COULD HAVE BECOME SHEARED OFF. PATIENT WAS REVISED FROM A SIZE 36 TO A SIZE 33 PATELLA.

  Patient problems: Injury

  MAUDE report 7883075 ↗
• InjuryFeb 16, 2018Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO DISLOCATION OF THE PATELLA. SURGEON ALSO REPORTED THAT THE FEMORAL COMPONENT LOOKED ROTATED AND REVISED THE ENTIRE CONSTRUCT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7276913 ↗
• InjuryJul 25, 2017Loss of Osseointegration; Loss of Osseointegration

  IT WAS DISCOVERED DURING A MONITORING VISIT FOR A STRYKER TRIATHLON CONES OUTCOMES STUDY (A REVISION STUDY): PATIENT HAD A DEEP WOUND INFECTION STARTING A FEW DAYS PRIOR TO HOSPITALIZATION ON (B)(6) 2017. PATIENT WAS ADMITTED FOR DEBRIDEMENT AND ANTIBIOTIC TREATMENT. PATIENT WENT TO OPERATING ROOM ON (B)(6) 2017 FOR SEPTIC KNEE WITH: IRRIGATION AND DEBRIDEMENT, SYNOVECTOMY, POLYETHYLENE LINER EXCHANGE, REMOVAL OF LOOSE PATELLAR IMPLANT AND RETAINED PATELLAR CEMENT. CULTURES POSITIVE FOR (B)(6). PATIENT ALSO HAD CARDIAC COMPLICATION DURING SAME ADMISSION.

  Patient problems: Injury; Sepsis; Synovitis; Unspecified Infection

  MAUDE report 6740574 ↗