Triathlon 5531-G-513Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327045888), received between May 24, 2017 and Aug 12, 2024 — classified as 14 injuries, 1 malfunction.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Unstable; Unstable

  THIS PI IS FOR LEFT KNEE. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. PATIENT REPORTED PAIN, WEAKNESS AND INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19967848 ↗
• InjuryAug 9, 2024Unstable; Unstable

  PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. THIS PI IS FOR RIGHT KNEE. UPDATE: 18-JUL-2024: PATIENT REPORTED PAIN, WEAKNESS AND INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19947594 ↗
• InjuryJun 13, 2024Degraded; Fracture; Degraded; Fracture

  PATIENT SHOWED TO CLINIC WITH SIGNIFICANT IMBALANCE IN JOINT SPACE. UPON REVISION WE FOUND THE POSTERIOR MEDIAL CORNER OF THE POLY HAD BEEN BROKEN. IT WAS THE RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19528877 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. THE PATIENT HAD A RUPTURED QUADRICEPS TENDON. WHILE PERFORMING TENDON REPAIR, SURGEON DECIDED TO EXCHANGE THE 5X13 INSERT FOR ANOTHER 5X13 INSERT.

  Patient problems: Rupture

  MAUDE report 15263737 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEPTIC ARTHRITIS, LEFT KNEE. ARTHROTOMY, IRRIGATION, AND DEBRIDEMENT AND TIBIAL POLYETHYLENE EXCHANGE FOR INFECTED LEFT TOTAL KNEE REPLACEMENT.

  Patient problems: Arthritis; Unspecified Infection

  MAUDE report 11555617 ↗
• InjuryMar 23, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S ENTIRE CR KNEE WAS REVISED TO A TS KNEE. REP PROVIDED PRIMARY USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11555005 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. A SIZE 5 TRIATHLON TIBIAL COMPONENT AND 5 X 13 CS INSERT WERE REVISED TO A SIZE 4 TRIATHLON TIBIAL COMPONENT AND 4 X 14 CS INSERT. SPOKE TO REP, PATIENT WAS REVISED ONE DAY AFTER THE PRIMARY. SURGEON NOTICED SOME MEDICAL OVERHANG ON THE TIBIAL COMPONENT WHICH HAD SHIFTED. SURGEON TOOK OUT LINER AND TIBIAL COMPONENT AND DOWNSIZED BOTH. WHEN DOWNSIZING THE POLY, SURGEON DECIDED TO INCREASE THE THICKNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11044949 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION CONTRACTURE. THE PATIENT'S CR KNEE WAS REVISED TO AN MRH KNEE (PATELLAR COMPONENT WAS RETAINED). REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 10654376 ↗
• InjuryAug 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE RIGHT KNEE. AS REPORTED IN PI (B)(4): IT WAS REPORTED BY THE SALE REP THAT THE HCP IS CONCERNED OVER A/P INSTABILITY & ANTERIOR SUBLUXATION OF FEMUR USING CS INSERT AFTER THE PRIMARY SURGERY. REFER PHOTO IN INTAKE TAB. PATIENT FUNCTION IS NORMAL. PRIMARY SURGERY : (B)(6) 2019. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF CREATION OF THIS PI. IN RESPONSE TO FOLLOW-UP FOR PI (B)(4), A USAGE SHEET WAS PROVIDED AND NO FURTHER INFORMATION IS AVAILABLE AS IT IS BEING HELD BY THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 8913409 ↗
• 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 "FAILED LEFT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury

  MAUDE report 8755077 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE RIGHT HIP. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT KNEE PAIN, STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY."

  Patient problems: Injury; Pain

  MAUDE report 8753509 ↗
• InjuryDec 19, 2018Material Discolored; Unstable; Material Discolored; Unstable

  SENT TO SEM AND INVESTIGATE THE YELLOW COLORING COMPONENTS. IMPLANTED TRN-TKA. ACL-INCOMPETENT KNEE, ABSENCE OF INTERNAL AND EXTERNAL CARTILAGE, OA, HYPEREXTENDED KNEE. AFTER SEVERAL WEEKS, SWELLING, INSTABILITY AND HEMATOMA WERE OBSERVED, SO THE SYNOVECTOMY WAS PERFORMED. SUSPECTED INFECTION, BUT IT WAS DECIDED AN INFECTION NEGATIVE BASED ON INVESTIGATION. SINCE HEMATOMA WAS AGAIN OBSERVED, SYNOVIAL RESECTION AND INSERT EXCHANGED. THERE IS NO INFECTION. SYNOVIAL PROLIFERATION WAS EXTENDED DOWN TO THE INSERT. THE REPLACEMENT NEW INSERT WAS AN INCREASED THICKNESS OF 16 MM.

  Patient problems: Hematoma; Injury; Swelling

  MAUDE report 8181290 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2018. PATIENT UNDERWENT I&D WITH POLYETHYLENE LINER EXCHANGED ON (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7968828 ↗
• InjuryApr 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT I&D WITH LINER EXCHANGE FOLLOWING PRIMARY [LEFT] TKA [DUE TO PERIPROSTHETIC JOINT INFECTION].

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7421360 ↗
• MalfunctionMay 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CS POLY WAS REPLACED BY SAME SIZE BECAUSE IT WAS NOT FULLY SEATED WHEN LOCKING MECHANISM WAS ENGAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6588481 ↗