Triathlon 5551-G-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327014815), received between Jan 29, 2018 and Dec 11, 2025 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (10 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Degraded; Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT TOTAL KNEE. THE REVISION TODAY WAS DUE TO HYPER EXTENSION AND INSTABILITY. THE 11 MM INSERT WAS REMOVED AND REPLACED WITH A 14 MM INSERT TO ADDRESS THE INSTABILITY AND HYPER EXTENSION. IT WAS ALSO DISCOVERED THAT THE PATELLA IMPLANT WAS SHOWING SIGNS OF WEAR. THE PATELLA WAS REVISED TO A COMPETITOR PATELLA AS THAT IS WHAT WAS AVAILABLE AT THE HOSPITAL. THIS SURGERY WAS ADDED ON LATE AND INSERTS WERE REQUESTED SO PATELLA COMPONENTS WERE NOT ORDERED IN. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 23783546 ↗
• InjuryMar 28, 2023Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  PATIENT STATED THAT HIS RIGHT TRIATHLON KNEE IS "COMING APART", PRIMARY SURGERY (B)(6) 2011. STATES HIS KNEE CAP IS LOOSE AND EXPERIENCES SORENESS. PRIMARY SURGEON STATED TO HIM HE WOULD "NOT" DO A REVISION DUE TO HIS AGE AND HEART. PATIENT SOUGHT A SECOND OPINION, FEBRUARY 2023, DR. CONFIRMED THAT HIS KNEE CAP IS LOOSE. XRAYS CONFIRM THAT THE KNEE CAP IS IN "TWO PIECES". HE ALSO HAD A PROTRUDING BULGE ON THE KNEE AT THE TIME OF THE SECOND OPINION. PATIENT STATED THAT SINCE HIS SECOND OPINION IN FEBRUARY HE NOW HAS 2-3 KNEE BULGES/LUMPS THAT ARE PALPABLE AND PROTRUDING HOWEVER CANNOT CONFIRM THEY ARE ACTUAL KNEE CAP "PIECES".

  Patient problems: Pain

  MAUDE report 16626578 ↗
• InjuryApr 25, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "SWOLLEN KNEE. UNSTABLE WHEN GETTING UP. DIFFICULTY WITH PUTTING ON SOCKS, TYING SHOES LACES; AND GETTING OUT OF DEEP CHAIRS."

  Patient problems: Ambulation or Postural Difficulties; Swelling/ Edema

  MAUDE report 14192812 ↗
• InjuryMar 12, 2021Unstable; Unstable

  REMOVAL OF PRIMARY TRIATHLON IMPLANTS DUE TO INSTABILITY AND REPLACEMENT WITH TRIATHLON TS

  Patient problems: Joint Laxity

  MAUDE report 11474325 ↗
• InjurySep 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: PATIENT HAD VISUAL PATELLA TILT WITH PAIN AND NOISE. THE FEMORAL COMPONENT, 4X9 CR INSERT, AND PATELLAR COMPONENT OF THE PATIENT'S LEFT KNEE WERE REVISED.

  Patient problems: Pain

  MAUDE report 10570002 ↗
• InjuryOct 22, 2019Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS NOTED THAT THE LEFT KNEE HAD AN ARTHROSCOPIC LATERAL RELEASE ON (B)(6) 2010.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 9219300 ↗
• InjurySep 4, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL LEFT TOTAL KNEE WITH OSTEOLYSIS OF THE TIBIAL COMPONENT, POLYETHYLENE WEAR.

  Patient problems: Injury; Pain

  MAUDE report 8960141 ↗
• InjuryAug 9, 2019Unstable; Unstable

  THIS PI IS FOR THE LEFT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT AND LEFT KNEE POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WITH INSTABILITY.

  Patient problems: Injury

  MAUDE report 8879983 ↗
• InjuryAug 9, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT KNEE CORONAL PLANE INSTABILITY.

  Patient problems: Injury

  MAUDE report 8879888 ↗
• InjuryAug 9, 2019Unstable; Unstable

  THIS PI IS FOR THE RIGHT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED . DUE TO RIGHT AND LEFT KNEE POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WITH INSTABILITY.

  Patient problems: Injury

  MAUDE report 8878777 ↗
• InjuryJul 2, 2019Unstable; Unstable

  THIS PI IS FOR THE LEFT KNEE IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY, ALL COMPONENTS." UPDATE (B)(6) 2019: AS PER MEDICAL REVIEW DATED (B)(6) 2019 "COMPONENT MALPOSITION OF TRIATHLON PS KNEE COMPONENTS WITH A ¿SIGNIFICANTLY ELEVATED JOINT LINE¿ HAS CONTRIBUTED TO GROSS INSTABILITY OF THE ARTHROPLASTY REQUIRING EXCHANGE OF ALL KNEE DEVICES AFTER 5-YEARS".

  Patient problems: Injury

  MAUDE report 8753918 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GLOBAL INSTABILITY OF RIGHT KNEE FOLLOWING TOTAL KNEE ARTHROPLASTY OF RIGHT KNEE WITH CHRONIC EFFUSIONS".

  Patient problems: Injury

  MAUDE report 8716911 ↗
• InjuryJun 20, 2019Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "MECHANICAL FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury

  MAUDE report 8716836 ↗
• InjuryJun 20, 2019Unstable; Unstable

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

  Patient problems: Injury

  MAUDE report 8716089 ↗
• InjuryJun 19, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8712739 ↗
• InjuryJun 19, 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 " LEFT TOTAL KNEE ARTHROPLASTY WITH LAXITY AND PAIN".

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 8712493 ↗
• InjuryMay 22, 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 "FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH CATASTROPHIC POLYETHYLENE FAILURE".

  Patient problems: Injury

  MAUDE report 8633080 ↗
• InjuryMay 1, 2019Osseointegration Problem; Osseointegration Problem

  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: Inadequate Osseointegration; Injury

  MAUDE report 8568439 ↗
• InjuryApr 11, 2019Unstable; Unstable

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

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8506486 ↗
• InjuryApr 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT TOTAL KNEE ARTHROPLASTY FAILURE WITH POLYETHYLENE WEAR, OSTEOLYSIS, AND ANTERIOR TO POSTERIOR INSTABILITY".

  Patient problems: Injury; Osteolysis

  MAUDE report 8505476 ↗
• InjuryApr 3, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY, LEFT TOTAL KNEE WITH LOOSE PATELLAR COMPONENT."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8479680 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8424761 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT KNEE OSTEOARTHRITIS AND RIGHT KNEE TOTAL ARTHROPLASTY FAILURE OR LOOSENING."

  Patient problems: Arthritis; Inadequate Osseointegration; Injury

  MAUDE report 8424668 ↗
• InjuryJul 27, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING AND PAIN.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7725703 ↗
• MalfunctionJan 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  UPON OPENING THE PATELLA IMPLANT, A HAIR WAS FOUND ON THE DEVICE. REP WAS PRESENT IN THE OPERATING ROOM AT THE TIME OF DISCOVERY. DUE TO STERILITY CONCERNS, THE DEVICE WAS NOT USED AND REMOVED IMMEDIATELY FROM THE FIELD. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7225666 ↗