Triathlon 5530-G-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327050455), received between Mar 25, 2019 and Feb 18, 2025 — classified as 8 injuries, 1 malfunction.

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

• InjuryFeb 18, 2025Degraded; Unstable; Naturally Worn; Degraded; Unstable; Naturally Worn

  AS REPORTED: "REVISION LEFT TOTAL KNEE. THE SURGEON REQUESTED INVESTIGATION RESULTS FROM THIS COMPLAINT BECAUSE HE SAID THE IMPLANTS HAVE BEEN IN FOR LESS THAN 5 YEARS. NO INFORMATION FROM THE INDEX SURGERY WAS PROVIDED. THE KNEE WAS NOT REVISED TO STRYKER IMPLANTS SO THE ONLY INFORMATION I HAVE FROM THE DOCTOR OR HOSPITAL IS THE PICTURES PROVIDED BELOW. THE SURGEON ALSO REQUESTED THAT THE IMPLANTS BE RETURNED TO STRYKER FOR THE INVESTIGATION." REP CONFIRMED THAT A STRYKER PATELLAR COMPONENT WAS LEFT IN SITU.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 21395107 ↗
• InjuryMay 28, 2024Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR. A 3X13 CR INSERT WAS REVISED TO A 3X16 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 19403346 ↗
• InjuryFeb 22, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  KNEE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 16418233 ↗
• InjuryAug 15, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  REVISED A LEFT KNEE TRIATHLON TIBIAL INSERT DUE TO POSTERIOR POLY WEAR DUE TO A PCL RUPTURE AND SUBSEQUENT SUBLUXATION.

  Patient problems: Damage to Ligament(s); Subluxation

  MAUDE report 15230071 ↗
• InjuryOct 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE SIZE 3 BASEPLATE, SIZE 3 R CR FEMORAL COMPONENT, AND 3 X 13 CR TIBIAL INSERT WERE REVISED TO A TS KNEE. THE PATELLA WAS NOT REVISED. THE REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10720789 ↗
• InjuryAug 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PROCEDURE: REVISION ARTHROPLASTY TOTAL KNEE LEFT TOTAL KNEE POLY VERSUS FULL REVISION. PRE-OP DIAGNOSIS: STIFFNESS OF LEFT KNEE. SURGEON COMMENTED THERE IS A FLEXION CONTRACTURE SO HE DOWNSIZED POLY TO 12MM CS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8897789 ↗
• InjuryMay 23, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENTS RIGHT KNEE WAS REVISED DUE TO POLY WEAR. A 3X13 CR INSERT WAS REVISED TO A 3X13 CS INSERT. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8637993 ↗
• MalfunctionMay 17, 2019Fracture; Fracture

  THE FOLLOWING WAS REPORTED " DURING SURGERY THE DOCTOR PUT THE INSERT ON THE TIBIA PLATE. HE USED THE INSERT HAMMER TWICE HOWEVER INSERT DID NOT FIT PLATE. HE USED THE HAMMER AGAIN AND THE WIRE OF INSERT WAS BROKEN.THUS HE USED ANOTHER INSERT AND FITTED THE PLATE. AFTER WASHING, HE EXAMINED THE POSSIBILITY OF WIRE PIECES BY SIGHT AND THERE WAS NOT ANY PIECES.".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8619686 ↗
• InjuryMar 25, 2019Unstable; Material Deformation; Unstable; Material Deformation

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, EXTENSIVE DEFORMATION WAS OBSERVED ON THE TOP REAR OF THE INSERT. SURGEON CONFIRMED THAT NO IMPLANTS WERE MALALIGNED OR MALPOSITIONED. A 3X13 CR INSERT WAS EXCHANGED FOR A 3X19 CS INSERT. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8449316 ↗