Triathlon 5531-G-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327045741), received between Jul 10, 2018 and Mar 3, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.

• InjuryMar 3, 2026Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND FLEXION INSTABILITY. INTRA-OPERATIVELY, SIGNIFICANT INSERT WEAR WAS NOTED POSTERIORLY/ MEDIALLY, AND A PORTION OF THE BASEPLATE WAS BROKEN OFF (SURGEON REPORTED POSSIBLE CAUSE/ CONTRIBUTOR WAS THAT THE BASEPLATE WAS IMPLANTED WITH TOO MUCH POSTERIOR SLOPE). A CR/ CS KNEE WAS CONVERTED TO A TS KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 24494747 ↗
• InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS BROUGHT TO OR FOR REVISION TKR FOR SUBLUXATION OF TOTAL KNEE COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 19700162 ↗
• InjuryApr 17, 2023Degraded; Unstable; Naturally Worn; Degraded; Unstable; Naturally Worn

  KNEE REVISION DUE TO INSTABILITY. POLY WEAR.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 16758735 ↗
• InjuryMar 24, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FLEXION INSTABILITY. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED FOR THE INSERT: POSTERIOR MEDIAL WEAR WITH A PIECE OF THE LIP CHIPPED OFF, POSTERIOR LATERAL WEAR WITH THE LIP WORN DOWN. A 3X13 CS INSERT WAS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 16610995 ↗
• InjuryJan 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE. INTRA-OPERATIVELY, THE LOCKING WIRE OF THE INSERT WAS OBSERVED TO HAVE BROKEN. THOUGH THE FEMORAL COMPONENT WAS WELL-FIXED, IT WAS REVISED IN ORDER TO ACCESS THE BASEPLATE. THE PATELLA WAS RETAINED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13405287 ↗
• InjuryJun 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN RESPONSE TO FOLLOW-UP FOR PI 2364534, MEDICAL RECORDS WERE PROVIDED WHICH INDICATE THE PATIENT HAD A LEFT KNEE ASPIRATION ON (B)(6) 2019. AS NOTED: "...SHE DEVELOPED FEVER, CHILLS, BILATERAL HIP AND LOW BACK DISCOMFORT...NO INFECTION WAS FOUND...WHEN SHE WALKS UP AND DOWN THE STAIRS SHE FEELS A POPPING IN HER LEFT KNEE ON THE INSIDE OF IT THAT ONLY HAPPENS WITH STAIRS...AN 18-GAUGE NEEDLE WAS USED TO ASPIRATE 50CC OF SEROSANGUINEOUS FLUID FROM THE POPLITEAL SPACE..."

  Patient problems: Aspiration/Inhalation; Discomfort; Fever

  MAUDE report 10162192 ↗
• InjuryJun 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN RESPONSE TO FOLLOW-UP, MEDICAL RECORDS WERE PROVIDED WHICH INDICATE THE PATIENT HAD A LEFT KNEE ASPIRATION ON (B)(6) 2019. AS NOTED: "...SHE HAS NOTICED THAT THE AREA IN THE BACK OF HER KNEE HAS 'SWELLED UP AGAIN.'...AN 18 GAUGE NEEDLE WAS USED TO ASPIRATE 90CC OF SANGUINEOUS FLUID FROM THE POPLITEAL SPACE."

  Patient problems: Aspiration/Inhalation; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 10161523 ↗
• InjuryMar 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY. THERE ARE NO ALLEGATIONS AGAINST THE STRYKER IMPLANTS. A 3X13 CS INSERT WAS REVISED TO A 3X19 CS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9785404 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT INDEX LEFT TOTAL KNEE REPLACEMENT OUTSIDE OF CORS SCOPE. PATIENT UNDERWENT LEFT KNEE REVISION ON (B)(6) 2017 FOR PAIN AND DYSFUCTION ONLY POLYETHELINE WAS EXCHANGED. PATIENT CONTINUED WITH PAIN AND DYSFUNCTION, SO UNDERWENT ANOTHER REVISION, WITH OFF-LABEL USE ON (B)(6) 2019.

  Patient problems: Injury; Pain

  MAUDE report 9211043 ↗
• InjuryJul 2, 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 "PATELLOFEMORAL ARTHRITIS, POST PARTIAL TOTAL RIGHT KNEE REPLACEMENT."

  Patient problems: Arthritis; Injury

  MAUDE report 8753403 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  COVERED REVISION OF A TRIATHLON LT TKA ORIGINALLY IMPLANTED (B)(6) 2014. KNEE WAS FOUND TO BE INFECTED. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS IMPLANTED. PATIENT REQUESTED TO KEEP REMOVED IMPLANTS AND DID.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8608817 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2018. PATIENT HAD REVISION FOR THE INFECTED LEFT TOTAL KNEE ARTHROPLASTY. THE MODULAR POLYETHYLENE WAS EXCHANGED (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8568812 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED TOTAL KNEE. "REMOVAL OF IMPLANTS."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7674616 ↗