Triathlon 5520-B-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327050349), received between Feb 2, 2017 and Aug 18, 2026 — classified as 14 injuries, 7 malfunctions.

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration

  MAUDE report 50305891 ↗
• InjuryMay 15, 2025Unstable; Noise, Audible; Unstable; Noise, Audible

  PT. REPORTED; HAD A TOTAL RIGHT KNEE REPLACEMENT ON (B)(6) 2024 AND IT'S BEEN SEVEN MONTHS AND ONE DAY AND IT'S GETTING WORSE AND WORSE AND WORSE. THE DOCTOR TOLD HIM THEY ALL MAKE NOISE LIKE THAT. THE DOCTOR STATED THERE COULD BE TOO MUCH SPACE WHICH MAY HAVE CAUSED LOOSENESS. DO I NEED HELP TO SOLVE THIS PROBLEM BEFORE HE OPERATE ME AGAIN. PT. WANTS TO KNOW IF THE PART WAS DEFECTIVE OR IT WAS OVERSIZED OR IT'S NOT INSTALLED RIGHT. AUDIBLE CLICKING NOISE, SWELLING PAIN AND BURNING SENSATION.

  Patient problems: Burning Sensation; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 22025586 ↗
• InjuryJan 25, 2023Fracture; Fracture

  THERE WAS A FRACTURE OF THE TIBIAL TRAY, DAMAGE TO THE POLYETHYLENE INSERT ( SOME TIME AFTER THE ORIGINAL OPERATION) AND RELEASE OF THE ELEMENTS INTO THE JOINT. REVISION SURGERY ON (B)(6) 2023 WAS SUCCESSFULLY COMPLETED. THE INSERT WAS REPLACED WITH A NEW PS AND THE TIBIAL TRAY WAS REPLACED WITH A REVISION TS NO. 7 ALONG WITH 10 MM WASHERS, 100/ 21 MM PIN AND 6 MM OFFSET. PREVIOUSLY, THE PATIENT HAD ALSO UNDERGONE BARIATRIC SURGERY DUE TO HIGH BODY WEIGHT. UPDATE - THE PATIENT PRESENTED TO THE HOSPITAL AT THE BEGINNING OF (B)(6) 2022 WITH DISCOMFORT OF THE KNEE JOINT , PREVIOUSLY HE HAD PRIMARY KNEE SURGERY ON THE TRIATHLON PRIMARY SYSTEM , SOME TIME LATER A KNEE LAVAGE ( DERO ) AND PE INSERT REPLACEMENT WAS PERFORMED DUE TO SYMPTOMS OF INFECTION . PREVIOUSLY, THE PATIENT HAD ALSO UNDERGONE BARIATRIC SURGERY DUE TO HIGH BODY WEIGHT . AFTER THE PATIENT REPORTED IN (B)(6) 2022 AND WAS REFERRED FOR KNEE REVISION SURGERY.

  Patient problems: Discomfort

  MAUDE report 16240289 ↗
• InjuryNov 16, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. *UPDATE ON 11-MARCH-2022 PER MEDICAL REVIEW: "[...] JUNE 28, 2017: THERE IS IN OPERATION REPORT FROM DR. THE PRE-AND POSTOP DIAGNOSIS WAS PAINFUL AND UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. THE OPERATION PERFORMED WAS A REVISION LEFT TOTAL KNEE ARTHROPLASTY. THE IMPLANTS UTILIZED WERE A STRYKER TRIATHLON X3 19 MM POLYETHYLENE INSERT CS SIZE #6. OPERATIVE FINDINGS INCLUDED WELL FIXED IMPLANTS, NO PATELLA WEAR, MILD POSTERIOR MEDIAL TIBIAL INSERT WEAR, A FLEXION GAP THAT WAS EQUAL IN SIZE TO THE EXTENSION GAP, COMPETENT POSTERIOR CRUCIATE LIGAMENT, FEMORAL AXIAL ROTATION SLIGHTLY EXTERNAL TO THE TIBIA WITH THE TIBIAL ROTATION AT THE JUNCTION OF THE MEDIAL AND MIDDLE THIRD OF THE TIBIAL TUBERCLE. THERE WAS CLEAR YELLOW FLUID PRESENT BUT NO EVIDENCE OF INFECTION. A 19 MM CS INSERT PROVIDED SATISFACTORY STABILITY ACCORDING TO THE SURGEON. [...]"

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 10842749 ↗
• InjuryApr 24, 2020Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY". UPDATE: BASED ON THE MEDICAL REVIEW DATED 24 MARCH 2020 [...] INITIAL SUBCLINICAL INSTABILITY HAS INCREASED WITH TIME UNDER DAILY LOAD FURTHER AND MAGNIFIED BY PATIENT'S OBESITY RESULTING IN CLINICAL INSTABILITY ULTIMATELY REQUIRING REVISION SURGERY WITH INCREASE IN CONSTRAINT ACROSS THE KNEE THROUGH USE OF TRIATHLON TS DEVICES.

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Laxity; Pain

  MAUDE report 9996404 ↗
• InjuryMar 24, 2020Malposition of Device; Malposition of Device

  PATIENT HAD JOINT LAXITY SO TOOK OUT ORIGINAL PS POLY AND REPLACED WITH A THICKER POLY. UPDATE 24-MAY-2019: IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GLOBAL INSTABILITY OF THE LEFT KNEE FOLLOWING LEFT TOTAL KNEE ARTHROPLASTY, WITH THIN POLYETHYLENE." UPDATE 26-FEB-2020: BASED ON MEDICAL REVIEW: X-RAYS OF THE LEFT KNEE AROUND 6-MONTHS FOLLOW-UP ON MAR 21, 2010, SHOW DEMARCATION BETWEEN THE BASEPLATE AND THE BONE CEMENT. THERE IS A SUGGESTION OF SUBSIDENCE ON THE MEDIAL SIDE OF THE BASEPLATE [...] X-RAYS POST FIRST LEFT KNEE REVISION ON (B)(6) 2015, CONFIRM A THICKER BEARING IN PLACE WITH OTHERWISE RETAINED FEMORAL COMPONENT, TIBIAL BASEPLATE AND PATELLAR DEVICE. SOME RADIOLUCENT LINE FORMATION IS STILL EVIDENT BELOW THE MEDIAL BASEPLATE SECTION WITH QUESTIONABLE OVERALL STABILITY [...]

  Patient problems: Injury; Joint Disorder

  MAUDE report 9873501 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON TIB BP CEMENTED #6 WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(4) HOSPITAL, WAS REDISTRIBUTED BY STRYKER AUSTRALIA AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT (B)(4) HOSPITAL. A FULL LOAN TRIATHLON IMPLANT SET WAS ACCIDENTALLY RETRIEVED FROM A HOSPITAL BY A COURIER AND WAS RETURNED TO A STRYKER KIT ROOM. HOWEVER, THE COURIER WAS UNAWARE THAT THE ITEMS WERE AFFECTED AND THEREFORE DID NOT COMMUNICATE TO THE KIT ROOM THAT THESE PARTS WERE PREVIOUSLY QUARANTINED AT THE HOSPITAL. AS A RESULT THE KIT ROOM DID NOT PROCEED WITH ANY QUARANTINE ACTION AND 18 OF THE AFFECTED ITEMS WERE RE-DISTRIBUTED. UPDATE 19/AUGUST/2019 WG: NONE OF THE PACKAGING WAS RETAINED FROM THE IMPLANTED DEVICES. SURGEONS EXPRESSED NO CONCERN, AND HAVE COMMUNICATED NO PLANS TO SURGICALLY ADDRESS THE IMPLANTATION OF THE DEVICES. TO DATE, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THESE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974446 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GLOBAL INSTABILITY OF RIGHT KNEE FOLLOWING TOTAL KNEE ARTHROPLASTY OF RIGHT KNEE WITH CHRONIC EFFUSIONS".

  Patient problems: Injury

  MAUDE report 8716915 ↗
• MalfunctionJun 12, 2019Scratched Material; Scratched Material

  BEFORE THE SURGEON WAS READY TO CEMENT IN THE BASEPLATE HE RECOGNIZED TWO DISTINCT LINES ON THE BOTTOM SURFACE OF THE BASEPLATE. UPDATE: "ISSUE RESOLVED BY OPENING AND USING A DIFFERENT BASEPLATE. 1 MINUTE DELAY FOR OPENING A NEW BASEPLATE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693217 ↗
• InjuryApr 26, 2019Noise, Audible; Noise, Audible

  THIS PI IS FOR CLICKING NOISE AND PAIN AFTER REVISION. AS PER OP REPORT, PATIENT IS EXPERIENCING PAIN AND CLICKING NOISE 2 WEEKS POST REVISION.

  Patient problems: Injury; Pain

  MAUDE report 8558085 ↗
• InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF RIGHT KNEE. DURING THE PRIMARY IMPLANTATION THE PATIENT WAS LEFT WITH 10 DEGREES HYPEREXTENSION. DURING THE REVISION SURGEON REPLACED ALL PARTS EXCEPT PATELLA, AND AUGEMNTS AND STEM WERE ADDED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8525180 ↗
• InjuryApr 3, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO "LEFT TOTAL KNEE JOINT REPLACEMENT UNSTABLE SECONDARY TO TOTAL KNEE JOINT REPLACEMENT."

  Patient problems: Injury

  MAUDE report 8479893 ↗
• InjuryFeb 22, 2019Unstable; Unstable

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT KNEE REPLACEMENT (B)(6) 2018. PATIENT RETURNED TO UNDERGO THE REVISION DUE TO PATELLAR INSTABILITY AND PAIN ON (B)(6) 2018 WITH A HINGE PROSTHESIS. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Pain

  MAUDE report 8361897 ↗
• MalfunctionAug 29, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A TKA, WHEN A SURGEON OPENED THE INNER BLISTER PACKAGE, HE FOUND SOME WHITE POWDER ON THE TIBIAL BASEPLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827974 ↗
• InjuryJul 27, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING AND PAIN.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7725705 ↗
• MalfunctionDec 11, 2017Device Packaging Compromised; Packaging Problem; Device Packaging Compromised; Packaging Problem

  IT WAS REPORTED THAT WHILE A RIGHT TKA WAS BEING PERFORMED, IMPLANT WAS OPENED. THE INNER BLISTER TYVEK WAS ADHERED TO THE OUTER BLISTER TYVEK, AND THE FOAM COVERING THE IMPLANT WAS ADHERED TO THE INNER BLISTER. DUE TO STERILITY CONCERN, SURGEON ELECTED TO NOT USE THE IMPLANT. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE AND THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. REP HAS ALL PACKAGING EXCEPT THE OUTER BOX, AND WILL BE PROVIDING PICTURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104737 ↗
• InjuryOct 20, 2017Malposition of Device; Malposition of Device

  PATIENT UNDERGOING REVISION OF THE LEFT KNEE BECAUSE HIS LEG IS STICKING OUT IN THE WRONG DIRECTION. SURGEON FEELS THE TIBIAL TRAY IS TOO INTERNALLY ROTATED. NOTHING IS LOOSE OR BROKEN.

  Patient problems: Injury

  MAUDE report 6966826 ↗
• MalfunctionAug 9, 2017Packaging Problem; Packaging Problem

  THE SURGEON OPENED THE STERILE PACKAGE CONTAINING THE TRIATHLON TIBIAL COMPONENT AND NOTICED, WHILE STILL IN THE PLASTIC TRAY, THAT THERE WAS A SMALL AMOUNT OF VERY FINE DEBRIS ON THE COMPONENT. HE WAS UNHAPPY TO USE THE COMPONENT AND ASKED FOR ANOTHER ONE. HE THEN NOTICED THE SECOND COMPONENT ALSO HAD THE SAME SMALL FINE DEBRIS ON IT. IT WAS A DIFFERENT BATCH NUMBER. THIS TIME HE WASHED THE COMPONENT WITH BETADINE AND IMPLANTED IT. IT WAS NOTICED AS THE SURGEON OPENED THE STERILE PACKAGING, BUT HAD NOT YET PICKED THE COMPONENT UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778732 ↗
• MalfunctionAug 9, 2017Packaging Problem; Packaging Problem

  THE SURGEON OPENED THE STERILE PACKAGE CONTAINING THE TRIATHLON TIBIAL COMPONENT AND NOTICED, WHILE STILL IN THE PLASTIC TRAY, THAT THERE WAS A SMALL AMOUNT OF VERY FINE DEBRIS ON THE COMPONENT. HE WAS UNHAPPY TO USE THE COMPONENT AND ASKED FOR ANOTHER ONE. HE THEN NOTICED THE SECOND COMPONENT ALSO HAD THE SAME SMALL FINE DEBRIS ON IT. IT WAS A DIFFERENT BATCH NUMBER. THIS TIME HE WASHED THE COMPONENT WITH BETADINE AND IMPLANTED IT. IT WAS NOTICED AS THE SURGEON OPENED THE STERILE PACKAGING, BUT HAD NOT YET PICKED THE COMPONENT UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778720 ↗
• MalfunctionJul 25, 2017Packaging Problem; Packaging Problem

  THE PLASTIC PACKAGING OF THE IMPLANT WAS CRUSHED AND STERILITY WAS QUESTIONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6742262 ↗
• InjuryFeb 2, 2017Mechanical Problem; Device Slipped; Unstable; Osseointegration Problem; Mechanical Problem; Osseointegration Problem

  PATIENT IS ENROLLED IN THE (B)(6) STUDY. THE STUDY COORDINATOR SENT AN E-MAIL TO NOTIFY US THAT THE PATIENT IS SCHEDULED FOR TIBIAL REVISION ON (B)(6) 2017. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2016 AND THE PA NOTED PAIN AND INSTABILITY WITH RADIOGRAPHIC EVIDENCE OF TIBIAL COMPONENT LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 6297677 ↗