Triathlon 5530-G-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327050431), received between Jul 18, 2018 and Dec 17, 2025 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  NO NEW INFORMATION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23830307 ↗
• InjuryAug 20, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY POSTERIOR WEAR WAS NOTED ON THE INSERT. A 3X9 CR INSERT WAS REVISED TO A 3X13 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 20002889 ↗
• InjuryMar 21, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. ALL IMPLANTS WERE REMOVED AND A COMPETITOR KNEE WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 16583328 ↗
• InjuryMar 13, 2023Unstable; Malposition of Device; Unstable; Malposition of Device

  THE FOLLOWING WAS REPORTED: KNEE REVISION DUE TO INSTABILITY. UPDATE 23 MAR 2023 - BASED ON THE CONCLUSION OF THE MEDICAL REVIEW, THE CLINICIAN STATED: 'THE ROOT CAUSE OF THE REVISION WAS REPORTED TO BE INSTABILITY. THERE WAS AN X-RAY THAT DID SHOW TIBIAL MALPOSITION WITH MARKED POSTERIOR SLOPE AND APPARENT SUBLUXATION.'

  Patient problems: Joint Laxity

  MAUDE report 16534993 ↗
• InjuryFeb 28, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: POLYETHYLENE INSERT WAS REVISED AFTER 5 YEARS POST SURGERY.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 16450866 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A WASHOUT WAS PERFORMED AND A 3X9 INSERT WAS EXCHANGED FOR A 3X10 INSERT. REP PROVIDED REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 16143615 ↗
• InjuryDec 16, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  REVISION KNEE ON (B)(6) 2022, POLY EXCHANGE OF A CS INSERT. DELAMINATED CS POLY ORIGINALLY IMPLANTED IN 2009. REVISION KNEE DATE ON (B)(6) 2022. POLY INSERTED IN 2009 WAS REPLACED WITH A 3X12MM CS POLY ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15994080 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOR "LYSIS OF ADHESION" TREATMENT IN (B)(6) 2018. PATIENT HAD A PRIMARY LEFT KNEE IMPLANT ON (B)(6), 2018 AND HAS BEEN EXPERIENCING LACK OF ROM AND CONSTANT PAIN. PATIENT NOTED A SMALL EFFUSION THAT SHOWED UP ON X-RAYS. (B)(6) 2018 PATIENT WAS TREATED FOR "LYSIS OF ADHESION" FOR EXCESSIVE SCAR TISSUE AND HAD AN ASPIRATION ON (B)(6), 2022. PATIENT IS SCHEDULED FOR A REVISION ON (B)(6) 2022. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

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

  MAUDE report 15742504 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "HURTS ALL THE TIME SINCE SURGERY. DIFFICULTY MOVING KNEE. PATIENT REPORTS SEVERE PAIN WITH KNEELING AND AMBULATING FROM SIT TO STANDING. PATIENT REPORTS SEVERE PAIN AND STATES "NOT PLEASED WITH OUTCOME."

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 14166189 ↗
• InjuryAug 16, 2021Degraded; Unstable; Degraded; Unstable

  AS REPORTED: "PAIN AND INSTABILITY. ALL AVAILABLE INFORMATION SUBMITTED." THE PATIENT'S RIGHT KNEE WAS REVISED. A 3X9 CR INSERT, SIZE 4 CR FEMORAL COMPOENT, AND SIZE 3 TRITANIUM BASEPLATE WERE REVISED TO A TS FEMORAL COMPONENT, PS INSERT, AND NEW BASEPLATE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12323559 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER MEDICAL REVIEW FOR, ADDITIONAL PIS WERE REPORTED. ON (B)(6) 2018 A RIGHT KNEE INCISION AND DRAINAGE, SYNOVECTOMY AND POLY LINER EXCHANGE WAS PERFORMED FOR A DIAGNOSIS OF ¿RIGHT TKR DEEP INFECTION¿. THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND THE USE OF A TOURNIQUET. THE OPERATIVE REPORTED NOTED, ¿¿ ASPIRATED LEFT KNEE AND 2 AND 3 ML CLEAR SYNOVIAL FLUID ¿ NO SIGN OF INFECTION ¿ PREVIOUS RIGHT KNEE INCISION WAS USED ¿ SIGNIFICANT PUS ¿ WASHOUT WITH 9 LITERS SALINE WITH BACITRACIN ¿ A NEW #3/9 CS INSERT WAS INSERTED ¿ FEMORAL AND TIBIAL COMPONENTS WELL-FIXED ¿ 1 GRAM VANCOMYCIN INTO THE WOUND¿. UNCOMPLICATED SURGERY WAS DESCRIBED.

  Patient problems: Bacterial Infection

  MAUDE report 12270605 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO HAD A DOUBLE KNEE REPLACEMENT IN (B)(6) 2017 WAS COMPLAINING OF SEVERE KNEE PAIN SUDDENLY.

  Patient problems: Pain

  MAUDE report 11734806 ↗
• InjuryMar 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A FRACTURED PATELLAR COMPONENT. INTRA-OPERATIVELY, THE PEGS OF THE PATELLAR COMPONENT WERE FOUND TO HAVE BEEN SHEARED OFF. PATIENT DENIED ANY TRAUMA OR FALLS PRIOR TO SURGERY. THE PIECES OF THE PATELLAR COMPONENT WERE REMOVED AND REVISED, AND A 3X9 CR INSERT WAS REVISED BY A 3X13 CS INSERT TO INCREASE PATIENT STABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11435376 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIGHTNESS IN FLEXION. A SIZE 3 CR FEMORAL COMPONENT AND 3 X 9 CR INSERT WERE REVISED TO A SIZE 2 FEMORAL COMPONENT AND 3 X 9 CS INSERT. REP CONFIRMED THAT OTHERWISE NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 11327863 ↗
• InjuryFeb 12, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO POLY WEAR. A 3X9 CR INSERT WAS REVISED TO A 3X10 CS INSERT. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11321949 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED "DURING THE IMPACTION OF THE LINER THE LOCK RELEASED FROM THE IMPLANT".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731365 ↗
• InjuryJan 2, 2019Noise, Audible; Noise, Audible

  AS REPORTED: "PATIENT COMPLAINED OF PAIN AND CLICKING IN KNEE. ALL AVAILABLE INFORMATION SUBMITTED". EXPLANT PICTURE PROVIDED BY THE REP SHOWS A METALBACK PATELLA WITH ITS POLY PORTION EXHIBITING NOTABLE DAMAGE. AN A32 METALBACK PATELLA AND 3X9 INSERT WERE REVISED TO AN A32 X3 PATELLA AND 3X11 CR INSERT.

  Patient problems: Injury; Pain

  MAUDE report 8209053 ↗
• InjurySep 14, 2018Fracture; Fracture

  REVISION SURGERY. SALES REP ADVISED OVER THE PHONE THAT THE REASON FOR REVISION WAS A FRACTURE IN THE ORIGINAL IMPLANT, WHICH CAUSED PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7876771 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM NOT IDENTIFIED). AN IRRIGATION AND DEBRIDEMENT WITH A POLY SWAP (SAME CATALOG NUMBER FOR REVISED AND IMPLANTED DEVICES) WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7700313 ↗