Triathlon 5532-G-513Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327050790), received between Apr 11, 2017 and Oct 20, 2025 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: BASED ON MEDICAL RECORDS, POSTOP RIGHT TKA PROGRESS NOTES ON (B)(6) 2015, THE PATIENT STATED "SHE STARTED HAVING LATERAL KNEE PAIN ON THE RIGHT KNEE. ASSESSMENT: SCAR TISSUE OVER THE RIGHT KNEE. PLAN: WE ASKED HER TO MASSAGE IT OR DO HOT TUB, WHIRLPOOL, BATHING, OR A HEATING PAD IN ORDER TO BREAK UP THE SCAR. WE ALSO DISCUSSED THAT IF IT DOES NOT GET BETTER, WE MAY TRY TO DO A COURSE OF INJECTIONS IN ORDER TO DECREASE THE AMOUNT OF SCAR. SURGICAL OPTIONS WOULD BE FOR ARTHROSCOPIC DEBRIDEMENT."

  Patient problems: Arthrofibrosis; Pain

  MAUDE report 23336067 ↗
• InjuryJul 8, 2025Unstable; Unstable

  UPDATE ON 15 SEP 2022 BASED ON MEDICAL RECORDS: "RIGHT TOTAL KNEE ARTHROPLASTY REVISION PROCEDURE NOTE (B)(6) 2022 [...] RADIOGRAPHS DEMONSTRATED SUBOPTIMAL POSITIONING OF HER COMPONENTS WITH FLEXION OF HER FEMORAL COMPONENT.

  Patient problems: Joint Laxity

  MAUDE report 22434616 ↗
• InjuryJul 19, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE SURGEON DECIDED TO USE A THICKER INSERT. BOTH THE PRIMARY AND REVISION USAGE SHEET HAVE BEEN PROVIDED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12193588 ↗
• InjuryJun 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE PATIENT'S RIGHT KNEE. IT WAS REPORTED THROUGH THE SUBMISSION OF CURRENT AND PREVIOUS REVISION USAGE SHEETS THAT THE PATIENT'S LEFT AND RIGHT KNEES WERE REVISED. A NOTE ON THE CURRENT REVISION USAGE SHEET STATES: "I&D BILATERAL KNEES." 5X13 PS INSERTS WERE SWAPPED FOR ANOTHER PAIR OF 5X13 PS INSERTS. UPDATE PER RESPONSE: "ASKED TO BE SEEN BY ORTHO AND HAVE POLYETHYLENES EXCHANGED ONCE AGAIN TO AID IN THE BATTLE OF (B)(6) ETC. PATIENT CANNOT SPEAK DUE TO BEING IN A VENTILATOR BUT WE KNOW HIS KNEES WERE DONE IN (B)(6). NOTHING FURTHER TO REPORT PER HOSPITAL POLICY."

  Patient problems: Injury

  MAUDE report 10194036 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED 7 WEEKS POST PRIMARY. THE PATIENT FELL AND SPLIT OPEN HIS WOUND AND THE SUTURES CLOSING IT. SURGEON PERFORMED A POLY SWAP AND WASHOUT, AND SENT CULTURES TAKEN INTRA-OPERATIVELY TO PATHOLOGY. INFECTION WAS NOT REPORTED TO THE REP. REP PROVIDED THE PRIMARY USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Fall; Injury

  MAUDE report 9070606 ↗
• InjurySep 5, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO UNSTABLE RIGHT TOTAL KNEE.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8964641 ↗
• InjuryAug 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSSIBLE INFECTION. A WASH-OUT AND POLY SWAP OF A 5X13 TS INSERT FOR A LIKE DEVICE WAS PERFORMED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8878692 ↗
• MalfunctionJun 11, 2019Mechanical Problem; Mechanical Problem

  SIZE 5 13MM X3 PS INSERT DID NOT SEAT FULLY. REMOVED AND REPLACED WITH DIFFERENT PS POLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687193 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REP REPORTED A REVISION OF A RIGHT KNEE DUE TO POSSIBLE INFECTION. A 5X13 PS INSERT WAS SWAPPED OUT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8608408 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  TRIATHLON PS IMPLANTS REMOVED SECONDARY TO INFECTION. FEMUR, TIBIA, POLY, PATELLA EXPLANTED. ANTIBIOTIC SPACER IMPLANTED. NO COMPLICATIONS. UPDATE 24/JANUARY/2019: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT COMPLAINED OF PAIN AFTER LOCAL TRAUMA TO THE AFFECTED AREA. BLOOD WORK CONFIRMED INFECTION IN CLINIC.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 8347606 ↗
• InjuryJan 3, 2019Mechanical Problem; Mechanical Problem

  POLYETHYLENE INSERT WASN¿T FULLY ENGAGED POSTERIORLY IN THE PATIENT¿S TKA REQUIRING A REVISION TO REPLACE THE INSERT.

  Patient problems: Injury

  MAUDE report 8214873 ↗
• MalfunctionDec 28, 2018Difficult to Insert; Difficult to Insert

  LINER WOULD NOT LOCK. UPDATE 05/DECEMBER/2018: REPORTER INDICATED "YES" TO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8203751 ↗
• InjuryOct 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON REMOVED A SIZE 5 X 13 TIBIAL INSERT AND REPLACED WITH A 5 X 16 PS TIBIAL INSERT. THIS WAS A LEFT KNEE. UPDATE 19/SEPTEMBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED AND ADVERSE CONSEQUENCE DETAILS: PATIENT HAD KNEE PAIN. BONE SCANS SHOWED TIBIAL AND FEMORAL COMPONENT TO BE INTACT AND NOT LOOSE. PATIENT UNDERWENT A REVISION SURGERY.

  Patient problems: Injury; Pain

  MAUDE report 7967385 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGEON WAS PERFORMING A REVISION ON A PATIENT.

  Patient problems: Injury

  MAUDE report 7897523 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 7450629 ↗
• InjurySep 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. POLY ONLY WAS REPLACED, ALL OTHER COMPONENTS WERE RETAINED FROM THE INITIAL PROCEDURE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6873581 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  COMPANY REPRESENTATIVE REPORTED PATIENT HAD KNEE REVISION.

  Patient problems: Injury

  MAUDE report 6699042 ↗
• InjuryApr 11, 2017Unstable; Insufficient Device Problem Information; Insufficient Device Problem Information

  DUE TO INSTABILITY, THE INSERT WAS REMOVED AND REPLACED WITH NEW ONE.

  Patient problems: Injury; No Code Available

  MAUDE report 6482441 ↗