Triathlon 5510-F-701Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327040333), received between Jan 17, 2019 and May 16, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Use of Device Problem; Use of Device Problem

  CEMENTED PROSTHESIS 5510F701 WAS OPENED DURING A CEMENTLESS PROCEDURE IN ERROR. BOTH SURGEON AND SCRUB NURSE CHECKED BOX. PROSTHESIS WAS IMPLANTED WITHOUT CEMENT. BECOME AWARE OF EVENT THROUGH JOINT REGISTRY HIGHLIGHTING TO THE HOSPITAL THAT NO CEMENT WAS USED. LEFT TKA PROCEDURE. REVISION OF COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 19330538 ↗
• InjuryDec 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED: "2 YEARS-OLD X3 INSERT ARE BROKEN ON THE BACK SIDE."

  Patient problems: Insufficient Information

  MAUDE report 13049287 ↗
• InjuryNov 16, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY UPDATE ON 11-MARCH-2022 PER MEDICAL REVIEW: "ON (B)(6) 2017: THERE IS IN OPERATION REPORT FROM DR. THE PRE-AND POSTOP DIAGNOSIS WAS PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. THE OPERATION PERFORMED WAS A REVISION LEFT TOTAL KNEE ARTHROPLASTY. THE IMPLANTS UTILIZED WERE A STRYKER TRIATHLON X3 19 MM POLYETHYLENE INSERT CS SIZE #6. OPERATIVE FINDINGS INCLUDED WELL FIXED IMPLANTS, NO PATELLA WEAR, MILD POSTERIOR MEDIAL TIBIAL INSERT WEAR, A FLEXION GAP THAT WAS EQUAL IN SIZE TO THE EXTENSION GAP, COMPETENT POSTERIOR CRUCIATE LIGAMENT, FEMORAL AXIAL ROTATION SLIGHTLY EXTERNAL TO THE TIBIA WITH THE TIBIAL ROTATION AT THE JUNCTION OF THE MEDIAL AND MIDDLE THIRD OF THE TIBIAL TUBERCLE. THERE WAS CLEAR YELLOW FLUID PRESENT BUT NO EVIDENCE OF INFECTION. A 19 MM CS INSERT PROVIDED SATISFACTORY STABILITY ACCORDING TO THE SURGEON."

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 10842750 ↗
• InjuryNov 9, 2020Osseointegration Problem; Osseointegration Problem

  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 LEFT TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO ALLEGED LOOSENING OF HIS KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10814571 ↗
• InjuryOct 14, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND LOOSENING. THE REP WAS NOT TOLD WHAT HAD LOOSENED. THE FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED TO COMPETITOR DEVICES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10677190 ↗
• MalfunctionSep 12, 2019Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED THAT WHEN THEY OPENED THE DEVICE THERE WAS DAMAGE DISCOVERED TO THE INNER PLASTIC PACKAGING OF A TRIATHLON FEMORAL IMPLANT DURING A TKR. THE CUSTOMER FURTHER REPORTED THAT THE RIM OF THE PLASTIC BOX ISN¿T COMPLETE ALL THE WAY AROUND. THIS PIECE OF PLASTIC THAT HAS SNAPPED OFF IS ACTUALLY STUCK TO THE BACK OF THE PEEL COVER. **UPDATE** THE CUSTOMER REPORTED THAT EVERY OTHER ASPECT OF THE PACKAGING WAS INTACT. A REPLACEMENT WAS USED TO COMPLETE THE CASE. AS REPORTED IN THE ATTACHED STRYKER COMPLAINT INTAKE FORM "THIS PRODUCT WAS NOT INTRODUCED INTO THE PROCEDURE/TAKEN INTO THE STERILE FIELD BY THE SURGEON. ANOTHER ONE OF THE CONSIGNMENT STOCK WAS OPENED, THIS DID NOT HAVE ANY DEFECTS/ISSUES, AND THE PROCEDURE WAS COMPLETED AS NORMAL". PROCEDURE WAS CONFIRMED AS A PRIMARY PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9006285 ↗
• InjuryAug 26, 2019Osseointegration Problem; Osseointegration Problem

  LEFT TKA WAS REVISED DUE TO A LOOSE FEMORAL COMPONENT. FEMUR WAS REPLACED WITH A TS FEMUR WITH AUGMENTS AND A STEM. UPDATE 01/AUGUST/2019: AS REPORTED IN HOW WAS ISSUE NOTICED "PATIENT SOUGHT TREATMENT FOR A PAINFUL SWOLLEN KNEE".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8932266 ↗
• MalfunctionApr 11, 2019Packaging Problem; Packaging Problem

  DURING A TOTAL KNEE REPLACEMENT, THE SURGEON WAS PREPARING TO IMPLANT THE TRIATHLON KNEE COMPONENTS. THE FEMORAL IMPLANT IN QUESTION WAS OPENED OUTSIDE THE STERILE FIELD. AS THE SURGEON WAS ABOUT TO ACCEPT THE IMPLANT HE NOTICED THAT ONE OF INNER HARD PLASTIC PACKAGING SHELLS WAS DAMAGED AND THEREFORE HE WAS CONCERNED THE PRODUCT MAY BE UNSTERILE. EVERY OTHER ASPECT OF PRODUCT PACKAGING SEEMED INTACT. THE RIM OF THE PLASTIC SHELL WASN¿T COMPLETE ALL THE WAY AROUND, IT LOOKS LIKE ONE SIDE SNAPPED AWAY AT SOME STAGE. THIS PIECE OF PLASTIC WASN¿T WITHIN THE PACKAGING ANYWHERE. SURGEON DID NOT TAKE THE PRODUCT INTO THE STERILE FIELD AS A RESULT, AND A REPLACEMENT PART WAS TAKEN FROM THE CONSIGNMENT SHELF AND USED AND THE PROCEDURE WAS COMPLETED AS NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503555 ↗
• InjuryJan 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "EVIDENTLY, PATIENT WAS AT PHYSICAL THERAPIST, AND WAS GOING THROUGH THERAPY. PATIENT HAD A SLIGHT FLEXION CONTRACTURE, SO THERAPIST PUSHED STRAIGHT DOWN ON TOP OF KNEE CAP, FELT A POP, AND THAT LOOSENED KNEE UP TO THE POINT SURGEON FELT A REVISION WAS NECESSARY. SURGEON DECIDED ON A TRIATHLON TS FEMUR WITH STEM, AND A POSTERIOR STABILIZED TIBIAL BEARING SURFACE, AND WAS SATISFIED WITH THE STABILITY. LEFT SIDE - NOTHING WAS LOOSE OR BROKEN.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8257931 ↗