Triathlon 5531-G-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327045758), received between Jul 30, 2018 and May 9, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR NERVE DAMAGE & EXTREME PAIN AFTER REVISION (AND ABLATION). "I HAD THE ABLATION DONE IN (B)(6) 2022.. FOR SOME REASON, MY RECORDS ONLY SHOW THAT I WENT FOR A FOLLOW UP APPOINTMENT AFTER THE ABLATION...IT DIDN¿T HELP...I ALSO HAD SPINAL INJECTIONS DONE AS I WAS TOLD THAT THE PAIN IN MY KNEE WAS CAUSED BY A NERVE IN MY LOWER BACK. AFTER THE 2 INJECTIONS IN MY LEFT LOWER HIP/BACK, I EXPERIENCED EXCRUCIATING PAIN IN THE INJECTION AREA ALONG WITH SEVERE THIGH, CALF, ANKLE, FEET AND HAND CRAMPING THAT STILL HAPPENS. THE DOCTOR WANTED TO DO MORE INJECTIONS AND I REFUSED. I TOLD THEM THAT THEY CAUSED ME MORE PAIN AND DISCOMFORT THAN I ALREADY HAD AND I WAS NOT GOING TO HAVE ANY MORE."

  Patient problems: Pain

  MAUDE report 19277788 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR NERVE DAMAGE & EXTREME PAIN AFTER REVISION OF THE PATIENT'S LEFT KNEE. I HAD A TOTAL KNEE REPLACEMENT DONE AND HAVE HAD MAJOR ISSUES WITH IT. THE PLASTICS WERE LOOSE CAUSING MY KNEE TO BUCKLE, LOCK UP, HAVE EXCESS SIDE TO SIDE MOVEMENT, CONSTANT PAIN IN MY LEFT KNEE AND, FELL DOWN STAIRS BECAUSE OF IT. I HAD A REVISION SURGERY DONE ON (B)(6) 2020, WHERE THE PLASTICS WERE REPLACED. I HAVE MADE MULTIPLE TRIPS TO MY ORTHOPEDIC DOCTOR FOR SEVERE PAIN IN MY KNEE BEFORE AND AFTER THE SECOND SURGERY WITH NO AVAIL. I AM EXTREMELY UNHAPPY WITH THE RESULTS OF THE KNEE REPLACEMENT AND NOW, SUFFER NERVE DAMAGE AND CONSTANT EXTREME PAIN IN MY LEFT KNEE. I WAS TOLD TO REACH OUT TO THE BBB TO REPORT MY ISSUE HOWEVER, I DECIDED TO GIVE Y¿ALL A CHANCE TO MAKE THIS RIGHT. THE PAIN IN MY KNEE IS SO SEVERE THAT I CAN¿T SLEEP AT NIGHT NOR CAN I PERFORM NORMAL DAY TO DAY ACTIVITIES.

  Patient problems: Nerve Damage; Pain

  MAUDE report 16025666 ↗
• InjuryFeb 27, 2019Fracture; Unstable; Fracture; Unstable

  SURGEON REVISED DUE TO INSTABILITY. IMPLANT RETRIEVAL NOTED FRACTURE POSTERIOR EDGE OF INSERT.

  Patient problems: Injury

  MAUDE report 8373445 ↗
• InjuryFeb 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. UPDATE 23/JANUARY/2019: SPOKE TO REP. A POLY SWAP WAS PERFORMED DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM UNKNOWN). A 3X16 CS INSERT WAS SWAPPED FOR ANOTHER DEVICE OF THE SAME CATALOG NUMBER. REP CAN PROVIDE ONE X-RAY, AND REPORTED NO FURTHER INFORMATION WOULD BE AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8345634 ↗
• InjuryFeb 12, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A SIZE 4 CR FEMUR AND 3X16 CS INSERT WERE REVISED TO A SIZE 4 TS FEMUR WITH STEM AND AUGMENTS, AND 3X16 TS INSERT.

  Patient problems: Injury

  MAUDE report 8333177 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. SURGEON REMOVED A 3X16 CS INSERT AND REPLACED IT WITH A 3X19 CS INSERT TO ENSURE STABILITY PROPHYLACTICALLY. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7887365 ↗
• InjuryJul 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 3X16 CS INSERT AND 3 CR FEMUR WERE REVISED TO A 3X19 TS INSERT, 3 TS FEMUR, 100MM STEM, 4 AUGMENTS, AND A NEW PATELLAR IMPLANT.

  Patient problems: Injury

  MAUDE report 7732185 ↗