Triathlon 5551-G-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327014808), received between Mar 1, 2017 and Mar 24, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE PATELLAR COMPONENT SHEARING OFF ITS PEGS. THE IMPLANT WAS REMOVED, ADDITIONAL BONE RESECTED, AND A NEW PATELLAR COMPONENT IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24675742 ↗
• InjuryOct 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A PEG SHEARING OFF OF THE PATELLAR COMPONENT. THE PATELLAR COMPONENT WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18009533 ↗
• InjuryApr 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO ANTERIOR KNEE PAIN. INTRA-OPERATIVELY, IT WAS NOTED THAT THE ALL POLY PATELLAR COMPONENT WAS FRACTURED. THE PATELLAR COMPONENT WAS REVISED.

  Patient problems: Pain

  MAUDE report 14187345 ↗
• 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: "[...] JUNE 28, 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 10842679 ↗
• InjuryNov 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO POSTERIOR FAILURE OF THE POLY INSERT AND WEAR OF THE PATELLAR COMPONENT. SURGERY OCCURRED ON (B)(6) 2020. ON (B)(6) 2020, REVISING SURGEON DISCOVERED THAT A RIGHT SIDED FEMORAL COMPONENT WAS IMPLANTED INTO THE LEFT KNEE APPROXIMATELY 8 YEARS AGO (BY A SURGEON WHO IS NOW RETIRED). REP WAS NOT PRESENT FOR THAT PROCEDURE. INTRA-OPERATIVELY, THE FEMORAL COMPONENT WAS DEEMED TO BE WELL-FIXED AND WAS NOT REVISED. THE PATELLAR COMPONENT AND A 4X13 CR INSERT WERE REVISED TO A NEW PATELLAR COMPONENT AND CS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 10819656 ↗
• InjuryJun 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED INCLUDES A REPORT DATED (B)(6) 2014: "...RECTUS FEMORIS COMPLETE RUPTURE AND RETRACTED 8CM FROM THE SUPERIOR POLE OF THE PATELLA...THE QUADRICEPS TENDON WILL BE REPAIRED..."

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 10173124 ↗
• InjurySep 5, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO UNSTABLE RIGHT TOTAL KNEE.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8964642 ↗
• InjurySep 5, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING LEFT TOTAL KNEE REPLACEMENT AND MORBID OBESITY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8964576 ↗
• InjuryJul 2, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8754239 ↗
• InjuryJun 11, 2019Unstable; Malposition of Device; Osseointegration Problem; Unstable; Malposition of Device; Osseointegration Problem

  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 8687096 ↗
• InjuryMay 1, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "ASEPTIC LOOSENING, COMBINED PATELLA FEMORAL MEDIAL COMPARTMENT ARTHROPLASTY, LEFT KNEE."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8570101 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY, RIGHT TOTAL KNEE ARTHORPLASTY".

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8421576 ↗
• InjuryOct 8, 2018Osseointegration Problem; No Apparent Adverse Event; Osseointegration Problem; No Apparent Adverse Event

  PATIENT CALLED STATING SHE HAD A LEFT KNEE REPLACEMENT ABOUT A YEAR AGO. FEW MONTHS AFTER IMPLANTATION SHE STARTED EXPERIENCING LOOSENING AND DIFFICULTY WALKING. PATIENT WAS REVISED TO COMPETITIVE DEVICES ON (B)(6) 2018. PATIENT IS SEEKING COMPENSATION. UPDATE PER MEDICAL REVIEW: PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018 (COMPETITOR DEVICES), NOT A LEFT KNEE REVISION. THIS PI TO COVER "LOOSENING & DIFFICULTY WALKING" WITHOUT REVISION.

  Patient problems: Inadequate Osseointegration; Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 7944394 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED THAT HIS INITIAL KNEE SURGERY WAS DONE ON (B)(6) 2017. HE HAS BEEN EXPERIENCING PAIN AND SURGICAL ISSUES FOR THE PAST 13 MONTHS SINCE HIS SURGERY WHICH LED TO A REVISION ON (B)(6) 2018. UPDATE AS PER MEDICAL REVIEW RECEIVED STATED THAT " ON APRIL 11, 2018 A NOTE STATES, "WILL UNDERGO REVISION RIGHT TKA ... FOR SEVERE NICKEL ALLERGY ...". ON (B)(6) 2018 A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, FEMUR AND TIBIA, WAS PERFORMED."

  Patient problems: Injury; Pain

  MAUDE report 7611238 ↗
• MalfunctionMar 1, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THERE WAS A FIBER ON IMPLANT WHEN OPENED DURING SURGERY WHICH COMPROMISED STERILITY. NOT IMPLANTED. FIBER WAS SEEN DURING SURGERY, SURGEON DISCARDED AND USED A NEW ONE. UNABLE TO IDENTIFY TYPE OF FIBER. NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370495 ↗