Triathlon 5520-B-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327041569), received between Apr 2, 2018 and Dec 8, 2025 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  UPDATE BASED ON MEDICAL REVIEW: "ON THE X-RAYS PROVIDED IT APPEARED THAT THE TIBIA WAS SUBLUXED POSTERIORLY WHICH COULD BE THE CAUSE OF THE SWELLING IN THE KNEE."

  Patient problems: Swelling/ Edema

  MAUDE report 23744697 ↗
• InjuryNov 29, 2023Malposition of Device; Malposition of Device

  DAUGHTER OF PATIENT REPORTED THAT WITHIN A YEAR OF PRIMARY RIGHT KNEE SURGERY, (B)(6) 2019, HER MOTHER EXPERIENCED IMPLANT "FAILURE" AND WITHIN TWO YEARS REQUIRED A REVISION, (B)(6) 2021. PATIENT EXPERIENCED A FEMUR FRACTURE DURING THE REVISION WHICH REQUIRED A "ROD" TO BE PLACED. PATIENT CURRENTLY EXPERIENCES RIGHT KNEE STIFFNESS AND SWELLING. PATIENT DID EXPERIENCE PAIN AT/AROUND HER THIRD POST OP VISIT WHICH SHE REPORTED TO HER SURGEON AT THE TIME. PATIENT CONFIRMED THAT SHE WAS ACTIVELY DOING PHYSICAL THERAPY AT THE TIME OF THE ONSET OF PAIN. DAUGHTER IS INQUIRING IF IMPLANTS ARE SUBJECT TO A RECALL. UPDATE 11/14/2023: PER MEDICAL REVIEW ADDENDUM, THE SURGEON FOUND MALROTATION OF BOTH FEMUR AND TIBIA CONTRIBUTING TO THE PATIENT¿S SYMPTOMS, AS WELL AS MOST LIKELY LOOSENING OF THE FEMORAL COMPONENT BASED UPON EASE OF REMOVAL. UPDATE: 11/27/2023: PER MED REVIEW, THE SURGEON STATES THERE WAS NOTICE OF PART OF THE CEMENT MANTLE BEING BROKEN OFF AT APPROXIMATELY 3 MONTHS AFTER THE SURGERY

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18230565 ↗
• InjuryNov 14, 2023Malposition of Device; Malposition of Device

  REAMER CONTACTED WITH BONE PIN WHICH WAS PLACED IN TIBIA. IMPLANT WAS INSERTED. BUT IMPLANTS WHICH WERE PLACED IN TIBIA AND FEMUR WERE REMOVED DURING CURING OF CEMENT BECAUSE THESE IMPLANTS PLACED INTERNAL ROTATION. AT THAT TIME, POSTERIOR THIGH BONE AND ANTERIOR TIBIA WERE FRACTURED. ADDITIONAL INFORMATION: THE REAMER AND PIN CONTACTED, CAUSING IT TO REAM TOWARD A PLACE IT WASN'T SUPPOSED TO BE WHICH CAUSED THE INTERNAL ROTATION. X-RAY SHOWS THERE WAS NO FRACTURE LOCATED AT THE TIBIAL BONE PIN SITE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18130447 ↗
• InjurySep 13, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "REV RTKA- TIBIA WAS LOOSE(CAME FROM OUTSIDE, NOT SURE WHO DID IT)." A TIBIAL COMPONENT AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17735408 ↗
• InjuryJun 6, 2023Fracture; Fracture

  BROKEN BASEPLATE FOUND DURING SURGERY. SURGEON SAID PATIENT HAD FALL AND COMPLAINED OF PAIN - REVISING FOR PAIN.

  Patient problems: Fall; Pain

  MAUDE report 17076155 ↗
• InjuryOct 19, 2022Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  PRIMARY RIGHT TRIATHLON (TKA) BASEPLATE FOUND TO HAVE SUBSIDED FOLLOWING PRIMARY SURGERY. SURGEON REMOVED IT, REPLACED WITH UNIVERSAL BASEPLATE. FEMUR UNAFFECTED AND REMAINED IN SITU.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 15630996 ↗
• InjuryAug 23, 2022Migration; Migration

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE. THE BASEPLATE WAS REVISED. THE FEMORAL COMPONENT WAS REVISED BOTH TO CONVERT THE KNEE TO A TS, AND TO GAIN ACCESS TO THE BASEPLATE. INTRA-OPERATIVELY, SIGNIFICANT WEAR OF THE INSERT WAS NOTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15274920 ↗
• InjuryOct 14, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  SALE REP WAS INFORMED BY DOCTOR THAT THERE IS A REMOVAL SURGERY PLAN ON (B)(6) DUE TO INFECTED IMPLANT. UPDATE AS PER MED REVIEW DATED 19 SEPTEMBER 2021: UNDATED: RIGHT AP/LATERAL KNEE X-RAYS. GROSS LOOSENING OF TIBIA AND FEMUR. TIBIA WITH CATASTROPHIC FAILURE AND PROXIMAL TIBIAL FRACTURE. CONFIRMATION: A REVISION SURGERY AND INFECTION CANNOT BE CONFIRMED. CATASTROPHIC FAILURE AND COLLAPSE OF A TRIATHLON IMPLANT CONSTRUCT FEMUR AND TIBIA CAN BE CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 12632899 ↗
• InjurySep 20, 2021Unstable; Migration; Unstable; Migration

  THIS PR WAS RAISED FROM A MEDICAL REVIEW FOR ANOTHER EVENT. THE PATIENT HAD LEFT KNEE ARTHROPLASTY ON (B)(6) 2011. A QUAD REPAIR WAS CARRIED OUT SIX MONTHS POST IMPLANTATION. REVISION SURGERY TOOK PLACE ON (B)(6) 2012 DUE TO INSTABILITY WHEREBY THE INSERT WAS REVISED. REVISION SURGERY TOOK PLACE ON (B)(6) 2016 DUE TO SUBSIDENCE AND INSTABILITY WHEREBY ALL COMPONENTS WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12496842 ↗
• InjuryAug 6, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE. THE BASEPLATE AND INSERT WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12286480 ↗
• InjuryDec 22, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY (B)(6) 2015. PATIENT HAD RIGHT KNEE PAIN AND INSTABILITY FOR MORE THAN TWO YEARS. THEN PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION ON (B)(6) 2020. ALL COMPONENTS EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11056046 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2016 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO TIBIAL LOOSENING AND SUBSIDENCE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10801825 ↗
• InjuryNov 5, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2018 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO ALLEGED LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10790718 ↗
• InjuryApr 29, 2020Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  THIS PI WAS RAISED BASED ON THE MEDICAL REVIEW FOR. THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 WITH TRIATHLON CR COMPONENTS. POSTOPERATIVELY, FUNCTIONAL RECOVERY OF THE KNEE WAS HOWEVER SLOW REQUIRING CLOSED MANIPILATION OF THE KNEE UNDER ANAESTHESIA (MUA) ON (B)(6) 2014, ACHIEVING SOME 2°-110° OF KNEE FLEXION.

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

  MAUDE report 10011764 ↗
• InjuryNov 28, 2019Loss of Osseointegration; Loss of Osseointegration

  REVISION OF TIBIAL COMPONENT FOR LOOSENING.

  Patient problems: Injury

  MAUDE report 9390195 ↗
• 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 9285810 ↗
• InjuryOct 21, 2019Unstable; Unstable

  REVISION OF TRIATHLON KNEE DUE TO INSTABILITY AND SUSPECTED POLY WEAR.

  Patient problems: Injury

  MAUDE report 9213242 ↗
• InjurySep 18, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY". UPDATE (B)(6) 2019 BY OF, AS PER MEDICAL REVIEW: SUBOPTIMAL INITIAL DEVICE FIXATION THROUGH INCOMPLETE CEMENTATION OF THE TIBIAL BASEPLATE HAS CONTRIBUTED TO LOOSENING REQUIRING REVISION SURGERY. IT WOULD BE QUITE LIKELY THAT A LATE ONSET LOW- GRADE INFECTION OF HEMATOGENOUS ORIGIN HAS CONTRIBUTED AS WELL TO FAILURE WHILE PRIOR TO REVISION AN EXTENSIVE ARTHROSCOPIC DEBRIDEMENT OF THE KNEE MAY HAVE CONTRIBUTED TO INCREASED LIGAMENT LAXITY THEREBY INCREASING COMPLAINTS REQUIRING MORE EARLY INTERVENTION WITH REVISION SURGERY OF ALL COMPONENTS, REPLACED WITH A COMPETITOR'S DEVICE WITH AN ADEQUATE END RESULT.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 9081721 ↗
• InjurySep 5, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO A FAILED UNSTABLE LEFT KNEE REPLACEMENT.

  Patient problems: Injury

  MAUDE report 8964781 ↗
• 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; Loss of Range of Motion

  MAUDE report 8945149 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GROSS INSTABILITY STATUS POST PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury; Joint Laxity

  MAUDE report 8717111 ↗
• InjuryMay 21, 2019Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE REPLACEMENT, TIBIAL LOOSENING AND INSTABILITY".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8629639 ↗
• InjuryApr 4, 2019Unstable; Osseointegration Problem; Insufficient Device Problem Information; Unstable; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT TOTAL KNEE ARTHROPLASTY INSTABILITY PLUS LOOSE."

  Patient problems: Inadequate Osseointegration; Injury; Joint Laxity

  MAUDE report 8482398 ↗
• InjuryDec 5, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DURING REVISION, WAS NOTED THAT ALL COMPONENTS APPEARED WELL FIXED EXCEPT TIBIA.

  Patient problems: Injury

  MAUDE report 8135090 ↗
• InjuryNov 9, 2018Loss of Osseointegration; Loss of Osseointegration

  HOSPITAL PRACTITIONER REPORTED TO ANSM THE FOLLOWING EVENT : "PREVIOUSLY PRE-COATED OF A TIBIAL IMPLANT OF PTG. ELIMINATION OF AN INFECTION, CHANGED IN APPEARANCE OF THE POLYETHYLINE TIBIAL PLATEAU THAT IS YELLOW". UPDATE OF DESCRIPTION OF THE INCIDENT: EARLY LOOSENING 1 YEAR OF A PTG TIBIAL IMPLANT. ELIMINATION OF AN INFECTION. CURRENT PATIENT STATUS: RE-OPERATION WITH PTG RECOVERY".

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 8055491 ↗