Triathlon 5530-G-513Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327050554), received between Oct 30, 2018 and Nov 17, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Material Discolored; Material Erosion; Fracture; Unstable; Material Discolored; Material Erosion; Fracture; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12832382 ↗
• InjurySep 9, 2019Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  KNEE REVISION DUE TO POLY WEAR. UPDATE: ADDITIONAL COMMENT PROVIDED BY CLINICIAN: "REVIEW OF X-RAYS REVEAL THE TIBIAL COMPONENT IS IN 5 DEGREES IN VARUS AND 5 DEGREES IN POSTERIAL SLOPE. TO MORE ACCURATELY DETERMINE ALIGNMENT, FULL LENGTH X-RAYS WOULD BE REQUIRED."

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 8975671 ↗
• InjurySep 5, 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 ACUTE FAILURE STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY; RHEUMATOID ARTHRITIS.

  Patient problems: Injury; Rheumatoid Arthritis

  MAUDE report 8964786 ↗
• InjuryMar 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DOCTOR REPORTS THAT THE PATIENT HAD A POST RIGHT TOTAL KNEE REPLACEMENT DONE ON (B)(6) 2018 HAS A FLEXION CONTRACTION OF HIS KNEE AND HE REQUESTED TO EXCHANGE THE INSERT FROM A 13MM TO A 9MM AND PERFORM VARIOUS RELEASES TO GET EXTENSION. THE POLY WAS EXCHANGED WITHOUT INCIDENT. NEARLY FULL EXTENSION WAS ACHIEVED. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8436132 ↗
• InjuryMar 19, 2019Naturally Worn; Naturally Worn

  POLY WEAR ON TRIATHLON KNEE NEED KNEE REVISION ** UPDATE BASED ON THE MEDICAL REVIEW, QS 21 MAY 2019: "RELEVANT CLINICAL HISTORY AND TIME LINES" [...] "CLINICAL EXAMINATION AND X-RAYS WERE REPORTED AS ¿NORMAL¿ BUT A DIAGNOSTIC ARTHROSCOPY OF THE LEFT KNEE DOCUMENTED WEAR IN BOTH THE MEDIAL AND LATERAL POSTERIOR SEGMENTS OF THE BEARING. MODERATE INSTABILITY WAS SHOWN DURING ARTHROSCOPY." [...] "CONCLUSION OF ASSESSMENT: BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE OF 10° HAS CONTRIBUTED TO FLEXION INSTABILITY OF THE KNEE ARTHROPLASTY CAUSING THE FEMORAL COMPONENT TO RIDE OVER THE POSTERIOR TIBIAL BEARING BORDER WITH CONSEQUENT POLYETHYLENE WEAR WITH PAIN REQUIRING REVISION SURGERY." [...]

  Patient problems: Injury

  MAUDE report 8434003 ↗
• InjuryDec 20, 2018Naturally Worn; Naturally Worn

  KNEE REVISION DUE TO POLY WEAR.

  Patient problems: Injury

  MAUDE report 8187454 ↗
• InjuryDec 3, 2018Device Dislodged or Dislocated; Scratched Material; Device Dislodged or Dislocated; Scratched Material

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. AN A35 PATELLA AND 5X13 CR INSERT WERE REVISED TO AN A38 PATELLA AND 5X16 CR INSERT. REP PROVIDED A PRIMARY OPERATIVE NOTE, WEBOPS REPORT OF THE PRIMARY IMPLANTS, EXAMINATION NOTE, PRE-REVISION X-RAYS, AND A PICTURE OF THE EXPLANTS AND REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN SUBMITTED. UPDATE: X-RAY FROM (B)(6) 2018 SHOW LATERAL PATELLA SUBLUXATION OF THE LEFT KNEE.

  Patient problems: Injury; Pain

  MAUDE report 8126688 ↗
• InjuryOct 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "RIGHT KNEE REVISION, ONE COMPONENT (POLY). MECHANICAL COMPLICATION OF RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8021377 ↗