Triathlon 5510-F-702Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327040357), received between Aug 29, 2017 and Dec 11, 2023 — classified as 5 injuries, 3 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Loss of Osseointegration; Loss of Osseointegration

  AS DESCRIBED BY PATIENT: "CAN THE LOWER PART OF THE TRIATHLON COME LOOSE IN THE BONE? MINE APPEARS TO BE LOSE. GOING FOR X-RAYS".

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18299668 ↗
• InjuryMar 15, 2022Unstable; Unstable

  AS REPORTED: "PT. PRESENTED WITH MID-FLEXION INSTABILITY. OPTED TO REVISE THE FEMUR COMPONENT AND INSERT OPTION, LEAVING THE TIBIAL-BASEPLATE COMPONENT IN-SITU." RIGHT KNEE. A CR FEMORAL COMPONENT AND CS INSERT WERE REVISED TO A TS FEMORAL COMPONENT WITH STEM, EXTENDER, AND AUGMENTS, AND A TS INSERT. REP PROVIDED REVISION USAGE SHEET. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  MAUDE report 13767232 ↗
• InjuryNov 10, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2017 THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT HE WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED LOOSENING OF HIS KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10816692 ↗
• InjurySep 24, 2020Fracture; Fracture

  PATIENT WAS EXPERIENCING PAIN AND SWELLING. PATIENT WAS BOOKED FOR A TKA REVISION. UPON EXPOSURE OF THE ORIGINAL CR FEMORAL COMPONENT IT WAS DISCOVERED THAT THE FEMORAL IMPLANT WAS BROKEN IN TWO PIECES AT THE POSTERIOR LATERAL FEMORAL CONDYLE. THE RIGHT FEMUR WAS REMOVED AND REPLACED WITH A TS FEMUR.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 10580002 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON-CR FEM CEMENT #7 RT WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(4), WAS REDISTRIBUTED BY STRYKER AUSTRALIA AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT (B)(4) HOSPITAL. A FULL LOAN TRIATHLON IMPLANT SET WAS ACCIDENTALLY RETRIEVED FROM A HOSPITAL BY A COURIER AND WAS RETURNED TO A STRYKER KIT ROOM. HOWEVER, THE COURIER WAS UNAWARE THAT THE ITEMS WERE AFFECTED AND THEREFORE DID NOT COMMUNICATE TO THE KIT ROOM THAT THESE PARTS WERE PREVIOUSLY QUARANTINED AT THE HOSPITAL. AS A RESULT THE KIT ROOM DID NOT PROCEED WITH ANY QUARANTINE ACTION AND 18 OF THE AFFECTED ITEMS WERE RE-DISTRIBUTED. UPDATE 19/AUGUST/2019 WG: NONE OF THE PACKAGING WAS RETAINED FROM THE IMPLANTED DEVICES. SURGEONS EXPRESSED NO CONCERN, AND HAVE COMMUNICATED NO PLANS TO SURGICALLY ADDRESS THE IMPLANTATION OF THE DEVICES. TO DATE, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THESE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974451 ↗
• InjuryMay 1, 2019Unstable; Unstable

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

  Patient problems: Injury

  MAUDE report 8568770 ↗
• MalfunctionApr 16, 2018Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT IN OPENING THE OUTER STERILE PACKAGING, THE RIM OF THE PLASTIC PACKAGING BROKE OFF WITH THE TYVEK. THE INNER PACKAGING WAS INTACT, BUT DUE TO STERILITY CONCERNS, THE IMPLANT WAS NOT USED AND WAS DISPOSED. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE, AND REP CONFIRMED THERE WAS NO SURGICAL DELAY WHATSOEVER. REP WAS PRESENT IN THE O.R. AND WITNESSED THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435292 ↗
• MalfunctionAug 29, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A PRIMARY TKA PROCEDURE ON PATIENT'S RIGHT KNEE, A TRIATHLON CEMENTED FEMUR WAS OPENED. THE OUTER PACKAGING WAS INTACT BUT THE INNER PLASTIC PACKAGING WAS BROKEN. THE SURGEON REFUSED TO USE THE IMPLANT AS ITS STERILITY COULD NOT BE ASSURED. A REPLACEMENT IMPLANT WAS PROCURED IN THE TIME IT TOOK TO MIX THE CEMENT - AS A RESULT, THERE WAS NO SURGICAL DELAY AND NO ADVERSE AFFECT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6827383 ↗