Triathlon 5531-G-209Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327045659), received between Mar 14, 2018 and Apr 2, 2024 — classified as 19 injuries, 3 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 2, 2024Degraded; Degraded

  DR. (B)(6) REVISED A LEFT TKA DONE ORIGINALLY MANUALLY ON (B)(6) 2016 DUE TO POSTERIOR WEAR OF THE TIBIAL INSERT AND METAL WEAR OF THE BASEPLATE FROM FEMORAL COMPONENT CONTACT. REVISED TO A UNIVERSAL BASEPLATE AND CEMENTED CR FEMUR. NO ALLEGATIONS MADE AGAINST THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19017671 ↗
• InjuryMar 3, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FLEXION INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE INSERT WAS OBSERVED TO HAVE WEAR ON THE POSTERIOR MEDIAL ASPECT. THE PATIENT'S CR KNEE WAS CONVERTED TO A TS KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 18823518 ↗
• InjuryDec 6, 2023Fracture; Fracture

  TRITHLON CS TIBIAL INSERT FRACTURE AT 1 YR POST IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 18272919 ↗
• MalfunctionApr 25, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  WHEN THE INSERT WAS CAST, IT WAS NOT FIXED AND THE LOCKING WIRE CAME OFF. A NEW IMPLANT WAS TAKEN OUT JUST IN CASE, AND THE INSERT WITH THE DISLODGED WIRE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194464 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL REVIEW IDENTIFIED , ADDITIONAL EVENTS: AT TWO MONTHS POSTOPERATIVE THE PATIENT'S RANGE OF MOTION WAS ONLY -5 TO 40¿. A MANIPULATION WAS CARRIED OUT ON (B)(6) 2011 AND THE SURGEON STATES HE WAS ABLE TO GET FULL EXTENSION WITH FLEXION TO APPROXIMATELY 125¿.

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

  MAUDE report 12300270 ↗
• InjuryNov 9, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT FELL ON OR ABOUT (B)(6) 2020 AND THEIR RIGHT KNEE WAS REVISED. A CS TIBIAL BEARING INSERT AND CR FEMORAL COMPONENT WERE REVISED TO A CEMENTED PS FEMORAL COMPONENT, SIZE 2 TRIATHLON TS PLUS X3 POLY, AND MODULAR DISTAL FEMORAL FIXATION PEG. SPOKE TO REP: POSTERIOR INSERT WEAR WAS NOTED INTRA-OPERATIVELY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 10808396 ↗
• MalfunctionNov 2, 2020Device Handling Problem; Device Handling Problem

  AT THE TIME OF INSERTING THE INSERT, IT COULD NOT BE INSERTED TO THE END AND THE LOCKING WIRE BECAME VISIBLE. EVEN IF IT WAS REMOVED ONCE AND THEN INSERTED AGAIN, THE LOCKING WIRE WAS LOOSENED. A NEW INSERT OF THE SAME SIZE WAS OPENED AND INSERTED, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 10770228 ↗
• InjuryOct 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR PATIENT 3 OF 10. SURGEON REPORTED HE IS EXPERIENCING A HIGH COMPLICATION RATE WITH PATIENTS WHOSE PRIMARY PROCEDURES WERE MAKO PROCEDURES. THE NATURE OF THE 10 CASES IS UNKNOWN AT THE TIME OF REPORT. COMPLICATIONS REPORTED INCLUDE EFFUSIONS, PAIN, STIFFNESS, POSSIBLY REQUIRING 'SCOPES' AND/ OR POLY EXCHANGES. THE NATURE OF INTERVENTION FOR EACH OF THE 10 PATIENTS IS UNKNOWN. UPDATE 01/SEPTEMBER/2020: AS REPORTED BY CLINICIAN REVIEW, PATIENT HAD AN ARTHROSCOPIC DEBRIDEMENT OF ADHESIONS OF HER LEFT KNEE ON (B)(6) 2020.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 10681107 ↗
• InjuryOct 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR PATIENT 1 OF 10. SURGEON REPORTED HE IS EXPERIENCING A HIGH COMPLICATION RATE WITH PATIENTS WHOSE PRIMARY PROCEDURES WERE MAKO PROCEDURES. THE NATURE OF THE 10 CASES IS UNKNOWN AT THE TIME OF REPORT. COMPLICATIONS REPORTED INCLUDE EFFUSIONS, PAIN, STIFFNESS, POSSIBLY REQUIRING 'SCOPES' AND/ OR POLY EXCHANGES. THE NATURE OF INTERVENTION FOR EACH OF THE 10 PATIENTS IS UNKNOWN. UPDATE 02/SEPTEMBER/2020 WG: CLINICIAN REVIEW OF ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT WAS EXPERIENCING "SIGNIFICANT PAIN" 1 YEAR POST OP AND HAD A LEFT KNEE ASPIRATION OF 15ML BLOODY SYNOVIAL FLUID IN (B)(6) 2020 (13 MONTHS POST OP).

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 10680757 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICIAN REVIEW OF ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT HAD A LEFT KNEE ASPIRATION 10ML BLOODY BUT CLEAR SYNOVIAL FLUID IN (B)(6) 2020 (7 MONTHS POST-OP) AFTER COMPLAINT OF PERSISTENT AND INCREASING PAIN AND SWELLING.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 10588526 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICIAN REVIEW OF ADDITIONAL INFORMATION RECEIVED FOR PI INDICATES PATIENT HAD A LEFT KNEE ARTHROSCOPIC DEBRIDEMENT OF ADHESIONS DUE TO PERSISTENT PAIN, SWELLING, AND LIMITED FUNCTION AND RANGE OF MOTION ON (B)(6) 2019.

  Patient problems: Inflammation; Pain

  MAUDE report 10586771 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT HAD A LEFT KNEE ASPIRATION OF CLEAR SYNOVIAL FLUID AFTER COMPLAINT OF PAIN ON (B)(6) 2019.

  Patient problems: Inflammation; Pain

  MAUDE report 10585037 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICIAN REVIEW OF ADDITIONAL INFORMATION RECEIVED FOR INDICATES PATIENT HAD A LEFT KNEE MANIPULATION DUE TO PAIN AND SWELLING ON (B)(6) 2019.

  Patient problems: Inflammation; Pain

  MAUDE report 10585034 ↗
• InjuryNov 6, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO AN UNSTABLE RIGHT KNEE PROSTHESIS WITH RECURRENT PATELLAR DISLOCATIONS.

  Patient problems: Injury

  MAUDE report 9285808 ↗
• InjuryOct 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REVISED A RIGHT TRIATHLON TIBIAL INSERT FROM A 2X9 TO ANOTHER 2X9. THE REASON WAS TO REMOVE SCAR TISSUE AND POSTERIOR OSTEOPHYTES AND SOFT TISSUES. ORIGINAL SURGERY WAS (B)(6) 2018 USING MAKO. UPDATE 25/SEPTEMBER/2019: SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE STRYKER IMPLANTS (INCLUDING POSITIONING) OR AGAINST THE PRIMARY ROBOTIC PROCEDURE.

  Patient problems: Injury; Scar Tissue

  MAUDE report 9221448 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "STIFF/ TIGHT TOTAL LEFT KNEE." REP INDICATED A TIBIAL BASEPLATE AND INSERT WERE REVISED TO STRYKER DEVICES.

  Patient problems: Injury

  MAUDE report 8945250 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN, REDNESS, AND IRRITATION. SURGEON SUSPECTED ACUTE INFECTION AND PERFORMED AN IRRIGATION AND DEBRIDEMENT WITH POLY SWAP (IT IS UNKNOWN IF INFECTION WAS CONFIRMED BY PATHOLOGY, INFECTING MICROORGANISM NOT IDENTIFIED). A 2X9 CS INSERT WAS EXCHANGED FOR THE SAME CATALOG NUMBER.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8379370 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT HAD LEFT KNEE AVON PATELLO-FEMORAL REPLACEMENT ON (B)(6) 2014. THE PATIENT UNDERWENT LEFT KNEE PATELLOFEMORAL REVISION ON (B)(6) 2018 DUE TO PAIN(REPORTED IN CORS PER 2026KNEE). NOW DUE TO PAIN THE PATIEN HAS A SECOND REVISION ON (B)(6) 2018. ALL COMPONENTS EXCEPT TIBIA EXCHANGED.THIS PI IS REPORTED FOR 2ND REVISION.

  Patient problems: Injury; Pain

  MAUDE report 8361895 ↗
• InjuryOct 2, 2018Material Discolored; Material Discolored

  HOSPITAL PRACTITIONER REPORTED THE FOLLOWING EVENT : " PREVIOUSLY PRE-COATED OF A TIBIAL IMPLANT OF PTG. ELIMINATION OF AN INFECTION, PRESENCE OF A CHANGE IN APPEARANCE OF THE POLYETHYLENE TIBIAL PLATEAU THAT IS YELLOW".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7928232 ↗
• InjuryAug 21, 2018Material Erosion; Material Deformation; Material Erosion; Material Deformation

  DR (B)(6) FROM THE HOSPITAL REPORTED TO MR (B)(6), RSM JOINT REPLACEMENT THE FOLLOWING EVENT: "I HAD A CALL FROM DR (B)(6) ON WEDNESDAY AFTERNOON FOR AN UNUSUALLY WORN PE X3 TRIATHLON IMPLANT. I RECOVERED THE IMPLANT YESTERDAY AND ACTUALLY THERE IS A BIG WEAR FOR A 1 YEAR BP.

  Patient problems: Injury

  MAUDE report 7803733 ↗
• InjuryJul 10, 2018Fracture; Fracture

  PROCEDURE: PATIENT UNDERWENT PRIMARY TKA (B)(6) 2012. PATIENT RETURNED COMPLAINING OF PAIN AND INSTABILITY TO WALK. UNDERWENT REVISION SECONDARY TO INSTABILITY AND FRACTURE OF THE POLYETHYLENE COMPONENT FROM A CS TO A PS. FEMUR AND POLY EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7674806 ↗
• MalfunctionMar 14, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING A TKA, WHEN A SURGEON OPENED THE INNER BLISTER PACK, HE FOUND A LOCKING WIRE POPPED TO OUTSIDE FROM THE PE INSERT. A SPARE WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339294 ↗