Triathlon 5531-G-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327045819), received between May 15, 2018 and Sep 27, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Unstable” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  REVISION OF INSERT OF PREVIOUS TRIATHLON IMPLANTED IN 2004 DUE TO LYSIS/LOOSE. PATELLA RESURFACED ALSO.

  Patient problems: Osteolysis

  MAUDE report 20319902 ↗
• InjuryAug 24, 2023Degraded; Fracture; Detachment of Device or Device Component; Degraded; Fracture; Detachment of Device or Device Component

  PATIENT HAD INITIAL KNEE REPLACEMENT APPROXIMATELY 8 YEARS AGO. TRIATHLON TRITANIUM. PATIENT CAME TO SEE DR. IN CLINIC WITH KNEE PAIN. X RAYS WERE TAKEN AND REVEALED THAT THE TIBIAL BASEPLATE WAS BROKEN AS WELL AS THE LATERAL POSTERIOR PROXIMAL FEMUR. REVISION SURGERY WAS ON (B)(6). ONCE THE KNEE WAS OPENED, WE NOTICED THE LOCKING WIRE ON POLY WAS BROKEN AS WELL. METAL WAS FLOATING AROUND THE JOINT AND ENDED UP UNDERNEATH THE POLY WHERE IT WAS WORK INTO THE BACKSIDE OF THE PLASTIC. ALL IMPLANTS WERE REMOVED AND REVISED WITH TRIATHLON TS. PER MEDICAL REVIEW: "THERE IS A FRACTURE OF THE INFERIOR POLE OF THE PATELLA PRESENT" WHICH REPORTEDLY "FULLY HEALED" WITHOUT MEDICAL INTERVENTION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 17609798 ↗
• InjuryMar 13, 2023Degraded; Unstable; Degraded; Unstable

  THE FOLLOWING WAS REPORTED: KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 16528421 ↗
• InjuryDec 12, 2022Naturally Worn; Naturally Worn

  THE FOLLOWING WAS REPORTED: REVISION FOR POLY EXCHANGE. WORE OUT LINER POSTERIOR. DURING REVISION, PULLED SMALL PIECES OF PLASTIC OUT. LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15957084 ↗
• InjuryNov 15, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15795958 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT INDEX TKA ON (B)(6) 2019. PATIENT PRESENTS WITH PAIN AND IS STUDIED FOR INFECTION. HE IS REVISED FOR PJI ON (B)(6) 2021. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 13728873 ↗
• InjuryJan 15, 2021Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A FRACTURED POLY. PATIENT FELL ON AN UNKNOWN DATE IN 2019, AND SURGEON BELIEVES THE FACTURE ORIGINATED FROM THAT. A 4X13 POLY WAS REVISED TO A 4X16 POLY. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 11178322 ↗
• InjuryDec 3, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 4X13 INSERT WAS EXCHANGED FOR A 4X22 INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 10941324 ↗
• InjuryJun 22, 2020Degraded; Unstable; Device Dislodged or Dislocated; Naturally Worn; Degraded; Unstable; Device Dislodged or Dislocated; Naturally Worn

  UPDATE: THE REASON FOR REVISION WAS ¿POLY WEAR.¿

  Patient problems: Injury; Joint Laxity

  MAUDE report 10179014 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT AND RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2014. PATIENT UNDERWENT TOTAL LEFT KNEE REVISION FOR INFECTION (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9211046 ↗
• InjuryAug 22, 2019Unstable; Unstable

  PATIENT ORIGINALLY HAD A TRIATHLON KNEE DONE IN (B)(6) 2015. PRESENTS TODAY FOR INSTABILITY AND A POLY EXCHANGE FROM A 13MM CS TO 16MM CS. UPDATE 29/JULY/2019: AS REPORTED IN HOW WAS ISSUE NOTICED "PATIENT COMPLAINS OF PAIN AND INSTABILITY".

  Patient problems: Injury; Pain

  MAUDE report 8920704 ↗
• InjuryApr 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THIS PI IS FOR THE LINER EXCHANGE AND PATELLA RESURFACING ON (B)(6) 2019. SURGEON REPORTS PATIENT STATUS POST LEFT TOTAL KNEE DONE ON (B)(6) 2015 AND A SUBSEQUENT DISTAL FEMUR FRACTURE ON THE LEFT SIDE WHICH APPEARED TO BE FIXED WITH AN ORIF PLATE HAS HAD SOME PATELLA PAIN RELATED TO NON-RESURFACING. DR DECIDED TO RESURFACE THE PATELLA AND CHANGE THE INSERT TO A THICKER SIZE. SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE DUE TO PASSWORD SECURED EMR.

  Patient problems: Injury; Pain

  MAUDE report 8518509 ↗
• InjuryDec 13, 2018Unstable; Unstable

  REVISION OF FEMORAL COMPONENT AND POLY EXCHANGE. UPDATE BASED ON CLARIFICATION RECEIVED FROM THE REP (B)(4) 11DEC2018: PATIENT COMPLAINTS - PAIN / INSTABILITY.

  Patient problems: Injury; Pain

  MAUDE report 8159690 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. SURGEON REVISED A 4X13 CS POLY TO A 4X11 CS POLY TO IMPROVE THE PATIENT'S ROM. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion

  MAUDE report 8108553 ↗
• InjuryNov 19, 2018Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. PATIENT NEEDED THICKER TIBIAL INSERT. EXCHANGED A 4X13 FOR A 4X16.

  Patient problems: Injury; Pain

  MAUDE report 8086738 ↗
• InjuryMay 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT COMPLAINED OF PAIN, DRAINAGE AND BROUGHT INTO SURGERY. ALL IMPLANTS REMOVED. ANTIBIOTIC SPACER USED.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7514147 ↗