Triathlon 5515-F-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327050356), received between Mar 8, 2017 and Jan 28, 2026 — classified as 10 injuries, 3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Bone Fracture(s); Fall; Periprosthetic fracture

  MAUDE report 24205575 ↗
• InjuryMay 13, 2025Adverse 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 PAIN. A PS FEMUR AND INSERT WERE REVISED TO A TS FEMUR AND INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 22010760 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMUR FRACTURE DURING THE TKA. SURGEON ASSUME THAT THIS EVENT OCCURRED BECAUSE OF POOR BONE QUALITY AND TOO MUCH OSTECTOMY. IS THERE ANY PROBLEM IN MAKING THE BOX?

  Patient problems: Bone Fracture(s)

  MAUDE report 11271198 ↗
• InjuryDec 23, 2019Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED LEFT TOTAL KNEE ARTHROPLASTY. UPDATE ON 26-NOV-2019 BY QS BASED ON MEDICAL REVIEW: LEFT KNEE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, UNDER THE DIAGNOSIS OF ¿FAILED LEFT KNEE ARTHROPLASTY¿ WITH EXCHANGE OF ALL STRYKER COMPONENTS FOR NON STRYKER REVISION KNEE DEVICES. AT EXPLORATION, THE INSTABILITY WAS CONFIRMED AND THE PATELLA WAS FOUND TOO THICK WITH 28-MM. THE FEMORAL COMPONENT WAS DEEMED LOOSE AS IT COULD BE ¿POPPED OUT¿ WITHOUT EFFORT. ONLY 7-WEEKS POST SURGERY, THE SECOND X-RAYS OF (B)(6) 2016, CONFIRMED ALREADY SIGNIFICANT PROXIMAL MIGRATION OF THE FEMORAL COMPONENT WITH MORE THAN 1-CM SUBSIDENCE COMPARED WITH THE PREVIOUS X-RAY OF (B)(6) 2016, WITH LUCENCY AND BONE RESORPTION ALONG ALMOST THE ENTIRE FEMORAL IMPLANT-BONE INTERFACE.

  Patient problems: Inadequate Osseointegration; Injury; Osteolysis

  MAUDE report 9512805 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " FAILED LEFT TOTAL KNEE REPLACEMENT, INSTABILITY AND SUSPECTED LOOSE OR MALPOSITIONED PATELLAR COMPONENT."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8686920 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2018. LEFT KNEE REVEALS SUBSIDED FEMORAL IMPLANT INTO VARUS. PATIENT UNDERWENT LEFT TOTAL KNEE REVISION WITH DISTAL FEMORAL REPLACEMENT FOR PERIPROSTHETIC LEFT FEMUR FRACTURE (B)(6) 2018.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8569654 ↗
• InjuryMay 1, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE TOTAL KNEE REPLACEMENT OF LEFT KNEE".

  Patient problems: Injury

  MAUDE report 8568437 ↗
• InjuryAug 28, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMUR AND TIBIA.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7823436 ↗
• MalfunctionMar 21, 2018Material Deformation; Material Deformation

  FEMUR SIZE 4 (RIGHT) GOT A SHRINKAGE CAVITY ON THE CONDYLE BEARING SURFACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7358465 ↗
• MalfunctionMar 14, 2018Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT DURING A PRIMARY LEFT TKA, OUTER BLISTER OF THE FEMORAL COMPONENT WAS OPENED AND WHAT APPEARED TO BE A HAIR WAS ON THE TYVEK OF THE INNER BLISTER. DUE TO STERILITY CONCERNS, SURGEON ELECTED NOT TO USE THE IMPLANT BEFORE IT ENTERED THE FIELD. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE AND REP REPORTED THAT NO SURGICAL DELAY WAS CAUSED. REP WAS PRESENT AT THE TIME OF DISCOVERY AND WITNESSED THE IMPLANT OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338969 ↗
• MalfunctionJul 26, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN THE CIRCULATOR WAS PASSING THE 3 LEFT PS CEMENTED (TRIATHLON) FEMUR TO THE SURGICAL TECH, THE IMPLANT COULD NOT BE REMOVED FROM THE INNER PACKAGING. IN ORDER TO AVOID ANY STERILIZATION CONCERNS, THE SURGEON HAD A NEW IMPLANT OPENED INSTEAD. THERE WERE NO SURGICAL DELAYS, AND NO ADVERSE AFFECTS TO THE PATIENT. THIS WAS DURING A PRIMARY SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746022 ↗
• InjuryJun 5, 2017Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP REPORTED A PRIMARY SURGERY OF KNEE WHICH THE FEMORAL CONDYLE BROKE DURING THE SURGERY. SURGEON PUT A NOTCH IN THE FEMUR (TAKE AWAY SOME OF THE BONE) TO MAKE THE IMPLANT FIT. IT DID FIT AS IT WAS BEING TAPPED AND BROKE THE LATERAL CONDYLE. SURGEON REIMPLANTED A STRYKER COMPONENT IN PLACE AND USED A COMPETITORS SCREWS.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 6611547 ↗
• InjuryMar 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT POSTOPERATIVE TOTAL KNEE REPLACEMENT ON (B)(6) 2017. SHE FELL AND SUSTAINED A PERIPROSTHETIC FRACTURE. SHE WAS SCHEDULED FOR REVISION SURGERY (B)(6). SHE WAS SUCCESSFULLY REVISED TO A MRH HINGE KNEE.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 6389966 ↗