Triathlon 5560-S-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327026702), received between Jan 8, 2019 and Oct 18, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2021Unstable; Unstable

  AS REPORTED: "PATIENT¿S [LEFT] FEMUR, POLY, FEMORAL STEM AND AUGMENTS REVISED DUE TO PAIN AND INSTABILITY. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12647869 ↗
• InjuryAug 17, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT IS A 57-YEAR-OLD FEMALE WHO PREVIOUSLY UNDERWENT RIGHT TOTAL KNEE REPLACEMENT - OUTSIDE CORS SCOPE (ROI IN 2016). SHE UNDERWENT REVISION FOR TIBIAL COMPONENT LOOSENING (B)(6) 2017, ALL COMPONENTS REVISED. PATIENT REQUIRED A SECOND REVISION DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT PERFORMED IN (B)(6) 2020. ALL COMPONENTS WHERE EXCHANGED." AN OP REPORT WAS PROVIDED WHICH CITED ASEPTIC LOOSENING OF THE TIBIA, AND "AROUND THE FEMUR, THERE WAS ALSO EXTENSIVE AMOUNT OF BONE LOSS AND THE FEMUR APPEARED TO BE ALSO LOOSE. WE THEREFORE DECIDED TO REMOVE BOTH COMPONENTS."

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 12334679 ↗
• InjuryDec 17, 2020Adverse 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. AS REPORTED: "PT. PRESENTED WITH PAIN AND LIMITED RANGE-OF-MOTION DUE TO FIBROTIC/SCAR TISSUE FORMATION. THE TIBIAL COMPONENTS WERE REVISED IN ORDER TO ADDRESS JOINT-TIGHTNESS IN BOTH THE EXTENSION AND FLEXION GAPS. ALTOGETHER, THE TIBIA-BASEPLATE, STEM, AND CORRESPONDING INSERT WERE SWAPPED OUT. THE TS CONE AUGMENT WAS NOT REMOVED, IT REMAINS IN-PLACE. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS, AND NO FURTHER INFORMATION IS AVAILABLE." THE PATIENT WAS REVISED FROM A SIZE 6 TRIATHLON BASEPLATE AND STEM (IMPLANTED ON (B)(6) 2020) WITH A 6 X 9 MM TS INSERT (IMPLANTED ON (B)(6) 2020) TO A SIZE 5 TRIATHLON BASEPLATE AND STEM WITH A 5 X 9 MM TS INSERT. SPOKE TO REP: CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11029250 ↗
• InjuryJul 25, 2019Mechanical Problem; Mechanical Problem

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6) 2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8825982 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT WHILE IMPLANTING THE STEM ATTACHED TO THE TS FEMORAL COMPONENT, THE PATIENT SUSTAINED A FEMORAL PERIPROSTHETIC FRACTURE. A SMALLER DIAMETER STEM WITH THE SAME TS FEMORAL COMPONENT WAS IMPLANTED. REP PROVIDED AN IMPLANT SHEET SHOWING THE WASTED STEM.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8734874 ↗
• InjuryJan 8, 2019Corroded; Loss of Osseointegration; Corroded; Loss of Osseointegration

  LETTER RECEIVED FROM PATIENT'S LAWYERS ADVISING THE STRYKER TS TRIATHLON KNEE REPLACEMENT IS "DEFECTIVE AND MATERIALLY CONTRIBUTED TO... ON GOING LEFT LOWER LIMB PROBLEMS INCLUDING THE DEVELOPMENT OF A PSEUDO-TUMOUR". PATIENT IS REPORTS LEFT KNEE PROBLEMS FOLLOWING SURGERY ON THE (B)(6) 2012. PLEASE SEE COMMUNICATION LOG FOR DETAILS REGARDING ADDITIONAL INFORMATION.

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

  MAUDE report 8229287 ↗