Triathlon 5520-B-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327041057), received between Feb 22, 2017 and Jan 7, 2026 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Loss of Osseointegration

  UPDATE: LEFT SIDE

  Patient problems: Inadequate Osseointegration

  MAUDE report 23995668 ↗
• InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration

  CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A RIGHT TKA ON (B)(6) 2016, AND WAS IMPLANTED WITH A TRIATHLON PS KNEE. IT IS ALLEGED THAT IN (B)(6) 2024, HE FOLLOWED UP WITH A SURGEON AS THE KNEE WAS SWOLLEN AND CONSTANTLY PAINFUL. HE WAS REVISED IN (B)(6) OF 2024, DUE TO ALLEGED LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 23080637 ↗
• InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED VIA PHONE THAT; THE PATIENT HAD A TOTAL KNEE REPLACEMENT IN (B)(6) 2019. THE WHOLE THING HAS FALLEN APART AND HAS TO BE REVISED NEXT MONTH. PAIN, FEELS IMPLANT MOVING, SWELLING ADDITIONAL INFO. ON (B)(6) 2024: LOOSENING. UPDATE ON 09-SEP-2024: PER HOSPITAL, PATIENT IS BEING REVISED ON (B)(6) 2024 TO COMPETITOR PRODUCT.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 20171051 ↗
• InjurySep 3, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT HAD A REVISION SURGERY WHERE THE TIBIAL BASEPLATE AND INSERT WERE REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. DURING THE REVISION SURGERY, WE COLLECTED CULTURE. AFTER REVISION SURGERY, PATHOLOGICAL TEST FOUND FUNGUS DIAGNOSIS (SCEDOSPORIM). UPDATE: IT WAS REPORTED THE PATIENT HAD A REVISION SURGERY WHERE THE TIBIAL BASEPLATE AND INSERT WERE REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT.

  Patient problems: Fungal Infection; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20125939 ↗
• InjuryMay 7, 2024Fracture; Fracture

  PATIENT VISITED OFFICE AND X-RAYS REVEALED AN ASYMMETRIC JOINT SPACE AND SUPPOSED TIBIAL BASEPLATE FRACTURE WITH POLY WEAR. PATIENT HAD REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19257847 ↗
• InjuryMay 9, 2023Degraded; Unstable; Degraded; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY (SURGEON REPORTED SUSPICION THAT A RUPTURED PCL WAS THE UNDERLYING CAUSE). INTRA-OPERATIVELY, IT WAS OBSERVED THAT THE INSERT WORE THROUGH POSTERIORLY AND THE FEMORAL COMPONENT WORE AGAINST THE BASEPLATE, CAUSING METALLOSIS. THE ENTIRE KNEE CONSTRUCT WAS REVISED TO A NEW TRIATHLON CONSTRUCT WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 16898745 ↗
• InjuryApr 25, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "SWOLLEN KNEE. UNSTABLE WHEN GETTING UP. DIFFICULTY WITH PUTTING ON SOCKS, TYING SHOES LACES; AND GETTING OUT OF DEEP CHAIRS."

  Patient problems: Ambulation or Postural Difficulties; Swelling/ Edema

  MAUDE report 14192818 ↗
• InjurySep 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL KNEE PAIN. A TIBIAL BASEPLATE AND PATELLAR COMPONENT IMPLANTED ON (B)(6) 2018 AND A FEMORAL COMPONENT, FIXATION PEG, AND INSERT IMPLANTED ON (B)(6) 2020 WERE REVISED TO A TRIATHLON TS KNEE WITH CONE AND STEMS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12532999 ↗
• InjuryMar 23, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S ENTIRE CR KNEE WAS REVISED TO A TS KNEE. REP PROVIDED PRIMARY USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11555017 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION CONTRACTURE. THE PATIENT'S CR KNEE WAS REVISED TO AN MRH KNEE (PATELLAR COMPONENT WAS RETAINED). REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 10654379 ↗
• InjuryJul 21, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2014 THE PATIENT UNDERWENT A TKA AND DURING THAT PROCEDURE SIMPLEX G-HV BONE CEMENT WAS UTILIZED TO CEMENT ALL COMPONENTS. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2018 AND "OPERATIVE NOTES SHOW THE COMPONENTS WERE GROSSLY LOOSE WITH NO SIGNS OF INFECTION." IT IS ALLEGED THAT THIS ASEPTIC LOOSENING AND DEBONDING OF THE TIBIAL COMPONENT RESULTED FROM THE SIMPLEX G-HV BONE CEMENT.

  Patient problems: Injury

  MAUDE report 10305600 ↗
• InjuryMar 31, 2020Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  ON (B)(6) 2020, A REVISION OF TRIATHLON THAT WAS IMPLANTED IN 2014. THE REVISION OCCURRED DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT. THE EXISTING FEMUR COMPONENT REMAINED STABLE AND WAS LEFT INSITU. THE TIBIA BASEPLATE AND INSERT WERE REMOVED AND REPLACED WITH A UNIVERSAL BASEPLATE AND 9/100MM STEM, TIBIA CONE AND CS INSERT. THE PROCEDURE DOESN¿T REQUIRE MONITORING. THE OUTCOME OF THE PROCEDURE WAS A SUCCESSFUL REVISION.

  Patient problems: Injury; Pain

  MAUDE report 9903865 ↗
• InjuryFeb 13, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT COMPLAINED OF PAIN. REVISION TOTAL KNEE FOR ASEPTIC LOOSENING. WE USED TS TRIATHLON W/ CONE. A SIZE 3 TIBIA WAS USED W/ A EXISTING SIZE 5 FEMUR. THE SURGEON WAS INFORMED THIS WAS A OFF LABEL USE.

  Patient problems: Injury

  MAUDE report 9708909 ↗
• InjuryDec 11, 2019Migration; Migration

  REVISION SURGERY: CHRONIC GONALGIA IN OUTCOME OF ARTHROSURFACE CFM. PATIENT UNDERWENT THE FIRST LEFT KNEE ARTHROPLASTY IMPLANT DUE TO A GONARTHROSIS. UPDATED BY QS ON 13-NOV-2019: PER PROVIDED MEDICAL REVIEW COMMENT: X-RAY DATED ON (B)(6) 2019 IS AN AP OF THE LEFT KNEE, PATELLA NOT VISUALIZED, A PRIMARY TKA IS IN PLACE WITH NO VISIBLE CEMENT WITH THE TIBIAL COMPONENT SUBSIDED MEDIALLY RESULTING IN A VARUS DEFORMITY OF THE KNEE.

  Patient problems: Injury

  MAUDE report 9452724 ↗
• 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 8964785 ↗
• InjurySep 5, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING LEFT TOTAL KNEE REPLACEMENT AND MORBID OBESITY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8964579 ↗
• InjuryAug 9, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL KNEE ARTHROPLASTY, MECHANICAL LOOSENING OF COMPONENTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8879236 ↗
• InjuryJul 2, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING TIBIAL COMPONENT."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8752763 ↗
• InjuryMay 1, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT PAINFUL TOTAL KNEE ARTHROPLASTY WITH LATERAL TIBIAL BASEPLATE OVERHANG AND POSSIBLE LOOSE FEMORAL COMPONENT".

  Patient problems: Injury; Pain

  MAUDE report 8568816 ↗
• InjuryMar 15, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT KNEE OSTEOARTHRITIS AND RIGHT KNEE TOTAL ARTHROPLASTY FAILURE OR LOOSENING." UPDATE:REVIEW OF THE RECORDS CONFIRM REVISION SURGERY WAS CARRIED OUT FOR ASEPTIC LOOSENING OF A TIBIAL COMPONENT IN A CEMENTED TKA.

  Patient problems: Arthritis; Inadequate Osseointegration; Injury

  MAUDE report 8424515 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PRE-OP FINDINGS: 1. ARTHROFIBROSIS AFTER RIGHT TOTAL KNEE ARTHORPLASTY, INDEX PROCEDURE (B)(6) 2016" AND "POST-OP FINDINGS: 1. PRE-OP MOTION 3-75; 2. POST-OP MOTION 0-120; 3. PARTIALLY LOOSE FEMORAL COMPONENT; 4. PARTIALLY LOOSE TIBIAL COMPONENT (MEDIAL SIDE); 5. RETAINED PATELLAR COMPONENT."

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8421119 ↗
• InjuryMar 5, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LATERAL SUBSIDENCE OF THE TIBIAL BASEPLATE. INTRA-OPERATIVELY, THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE. THE BASEPLATE AND 5X11 INSERT WERE REVISED TO A SIZE 5 UNIVERSAL BASEPLATE WITH A 15X100 CEMENTED STEM, TWO AUGMENTS, AND A 5X13 CS INSERT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury

  MAUDE report 8390140 ↗
• InjuryDec 12, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSE PATELLAR AND TIBIAL COMPONENTS (NO POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WERE REPORTED TO OR OBSERVED BY REP). A TRIATHLON SIZE 5 CEMENTED FIXED BASEPLATE, INSERT AND ALL POLY SIZE 38 PATELLA WERE REVISED TO A TRIATHLON BASEPLATE, INSERT AND STRYKER PATELLA. REP COULD NOT VERIFY IF CEMENT USED IN PRIMARY WAS STRYKER.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8157432 ↗
• MalfunctionOct 15, 2018Material Discolored; Material Discolored

  THE SURGEON REPORTED THAT WHEN HE OPENED THE TIBIAL BASE PLATE AND FEMORAL COMPONENT, BOTH ITEMS WERE DISCOLOURED AND DID NOT HAVE THE USUAL HIGH POLISHED APPEARANCE. THE SURGEON USED ALTERNATIVE DEVICES TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7965581 ↗
• InjuryAug 21, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PATIENT CALLED STATING SHE HAD A LEFT KNEE REPLACEMENT ABOUT A YEAR AGO. FEW MONTHS AFTER IMPLANTATION SHE STARTED EXPERIENCING LOOSENING AND DIFFICULTY WALKING. PATIENT WAS REVISED TO COMPETITIVE DEVICES ON (B)(6) 2018. PATIENT IS SEEKING COMPENSATION.

  Patient problems: Ambulation or Postural Difficulties; Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 7803652 ↗