Triathlon 5531-G-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327046007), received between Jun 14, 2017 and Apr 10, 2024 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE POLY EXCHANGE DUE TO INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19077360 ↗
• InjuryFeb 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: PATIENT HAD BILATERAL MANIPULATION UNDER ANESTHESIA. ONLY LEFT KNEE IMPLANTS WERE PROVIDED. THIS PI IS FOR THE PATIENT'S LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16290098 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION OF RIGHT TKA. PATIENT WAS ADMITTED FOR EXPLORATION, WASHOUT AND POLYETHYLENE INSERT EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 14338498 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN PROVIDING RECORDS FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2019, AN OFFICE VISIT NOTE FROM (B)(6) 2018 INDICATES PATIENT COMPLAINT OF PAIN AND RECURRING SWELLING. AN ASPIRATION "OF 30 CC OF BLOOD TINGED FLUID" WAS PERFORMED. STUDY SITE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 11192928 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN PROVIDING RECORDS FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2019, AN OFFICE VISIT NOTE FROM (B)(6) 2018 INDICATES PATIENT COMPLAINT OF TIGHTNESS, EFFUSION, AND CLUNKING. AN ASPIRATION WAS PERFORMED. STUDY SITE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11192927 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IN PROVIDING RECORDS FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2019, AN OFFICE VISIT NOTE FROM (B)(6) 2018 INDICATES PATIENT COMPLAINT OF PAIN AND SWELLING. AN ASPIRATION OF "35 CC OF SEROSANGUINEOUS FLUID" WAS PERFORMED. STUDY SITE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 11176236 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IN PROVIDING RECORDS FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2019, AN OFFICE VISIT NOTE FROM (B)(6) 2018 INDICATES AN ASPIRATION OF "40 CC OF SEROSANGUINEOUS FLUID" AFTER OBSERVATION OF "SMALL KNEE EFFUSION" STUDY SITE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11176235 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED AN I&D TIBIAL POLY EXCHANGE ON A RIGHT TRIATHLON KNEE DUE TO INFECTION ORIGINALLY DONE BY DR. AT AN UNKNOWN TIME AT A MINIMUM OF A YEAR AGO.

  Patient problems: Unspecified Infection

  MAUDE report 11130135 ↗
• InjuryDec 8, 2020Unstable; Unstable

  TRIATHLON TRITANIUM IMPLANTED AT INITIAL SURGERY. INSTABILITY LED TO FEMORAL AND INSERT EXCHANGE.

  Patient problems: Joint Laxity

  MAUDE report 10964779 ↗
• InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. PATIENT HAD A PRIOR PATELLA REPAIR WITH PLATES AND WIRES OF UNKNOWN MANUFACTURE IMPLANTED TO ADDRESS A PATELLAR FRACTURE (IT IS UNKNOWN IF STRYKER KNEE IMPLANTS WERE IN SITU AT THAT TIME). DUE TO NON-UNION, A PATELLECTOMY WAS PERFORMED. SURGEON DECIDED TO REVISE A 7X9 CS POLY TO A 7X13 CS POLY. REP WAS NOTIFIED OF THE PROCEDURE OVER A WEEK LATER AND WAS NOT PRESENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 10807833 ↗
• InjuryOct 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO STIFFNESS. THE CR FEMORAL COMPONENT AND 7X9 CS INSERT WERE REVISED TO A TS FEMUR AND 7X9 INSERT.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 10643659 ↗
• InjuryMay 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTION. PATIENT'S RIGHT KNEE WAS REVISED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10102040 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD RIGHT KNEE JOINT SPACE INFECTION. IMPLANTED ANTIBIOTIC SPACER WITH CR FEMUR AND ALL-POLY TIBIA. NO COMPLICATIONS. NO DAMAGE VISUALIZED TO PARTS OTHER THAN THAT CREATED DURING REMOVAL..."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9512984 ↗
• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED "PAINFUL TOTAL RIGHT KNEE WITH RECURRENT INTERNAL BLEEDING IN JOINT". REP INDICATED THE LINER WAS REVISED. 18 OCTOBER 2019; UPDATE AS PER MEDICAL REVIEW. THERE IS AN OPERATIVE REPORT DATED (B)(6) 2019 FOR AN OPEN SYNOVECTOMY WITH COAGULATION OF SOFT TISSUE AND CHANGE OF POLY FROM A #7/9 TO A #7/11 CS. THICKENED PERIARTICULAR SCAR TISSUE¿ HEMOSIDERIN IN THE SYNOVIUM¿ CHANGED POLY. UNCOMPLICATED SURGERY.

  Patient problems: Blood Loss; Injury

  MAUDE report 8892495 ↗
• InjuryFeb 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REQUIRED REVISION KNEE SURGERY DUE TO LEFT KNEE INFECTION. LINER REMOVED, WAS INTACT PRIOR TO REMOVAL. KNEE WASHED OUT AND LINER REPLACED. MANY TISSUE AND FLUID SAMPLES SENT TO PATHOLOGY. NEW PROSTHESIS IMPLANTED WAS 5531-G-709 LOT LHJ949 FEMORAL COMPONENT AND TIBIAL BASEPLATE REMAINED IN SITU.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8311734 ↗
• MalfunctionOct 31, 2018Difficult to Insert; Difficult to Insert

  THE LOCKING MECHANISM ON THE POLY INSERT WOULD NOT ENGAGE INTO TIBIAL BASEPLATE. SURGEON THEN STATED HE WOULD LIKE A NEW POLY AND DIFFERENT SIZE THICKNESS. OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026510 ↗
• InjuryOct 30, 2018Naturally Worn; Naturally Worn

  SALES REP REPORTED, "LEFT KNEE REVISION POLY EXCHANGE AND REMOVAL OF HARDWARE. 3 PHOTOS WILL BE INCLUDED WITH PER. PATELLA POLY WAS WORN THROUGH AND METAL RUBBING ON FEMUR. METALLOSIS WAS A TOPIC OF DISCUSSION BETWEEN THE SURGEONS. ALSO INFLAMMATION AND POLY WEAR. PATIENT IS KEEPING HIS IMPLANTS.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8021503 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. PATIENT WAS CONVERTED FROM A CR TO A PS CONSTRUCT.

  Patient problems: Injury; Pain

  MAUDE report 7797781 ↗
• InjuryJul 27, 2018Unstable; Unstable

  IT WAS REPORTED THAT PATIENTS' LEFT KNEE WAS REVISED DUE TO INSTABILITY AND PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7725576 ↗
• MalfunctionMay 23, 2018Detachment Of Device Component; Detachment Of Device Component

  "WHEN PLACING THE IMPLANT (IMPACTION), THE METALLIC WIRE DETACHED FROM THE IMPLANT, MAKING THE IMPLANTATION IMPOSSIBLE. THE INCIDENT HAPPENED FOR A SECOND TIME. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537884 ↗
• InjuryFeb 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. ALL COMPONENTS WHICH WERE ORIGINALLY IMPLANTED WERE EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7266757 ↗
• InjuryJun 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  TRIATHLON KNEE POLY INSERT EXCHANGE AND WASH OUT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6640217 ↗