Triathlon 5521-B-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327026351), received between Nov 30, 2017 and May 19, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  AS REPORTED: "LEFT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO TIBIAL LOOSENING. NO FURTHER INFORMATION AVAILABLE FROM DOCTOR OR HOSPITAL." A PS KNEE WAS REVISED TO A TS KNEE WITH STEMS AND AUGMENTS. SPOKE TO THE REP. THIS SURGEON DOES NOT DO TIBIA-ONLY REVISIONS, SO THE ENTIRE CONSTRUCT WAS REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMUR OR INSERT. PATELLAR COMPONENT WAS RETAINED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22048758 ↗
• InjuryNov 15, 2024Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE RIGHT KNEE. AS REPORTED: "DR. IS ASKING FOR US TO DOCUMENT AN INSTANCE OF ASEPTIC LOOSENING FOR A PATIENT SHE OPERATED ON (B)(6) 2022. THE PATIENT HAD BILATERAL TKA AND IS NOW BEING REVISED ON BOTH SIDES FOR LOOSENING. SHE HAD SHARED THE IMPLANT INFORMATION AND ASKED THAT WE CHECK THE LOT NUMBERS FOR ANY RECALLS." NONE OF THE REPORTED IMPLANTS WERE SUBJECT TO RECALL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20693302 ↗
• InjuryJun 30, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED FOR PAIN AND SUSPECTED LOOSENING OF THE TIBIAL BASEPLATE (CONFIRMED INTRA-OPERATIVELY AS A 'LITTLE LOOSE'). THE BASEPLATE AND INSERT WERE REVISED TO A BASEPLATE WITH STEM AND ANOTHER INSERT.

  Patient problems: Pain

  MAUDE report 14881234 ↗
• InjuryAug 13, 2019Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  PATIENT'S WIFE CALLED REPORTING PATIENT HAD LEFT KNEE REPLACEMENT SURGERY (B)(6) 2013. PATIENT BEGAN EXPERIENCING RANGE OF MOTION ISSUES AND WAS REVISED ON (B)(6) 2018. PATIENT'S WIFE REPORTS THAT REVISING SURGEON SHOWED HER AND HER HUSBAND PICTURES OF THE EXPLANTED DEVICE, AND EXPLAINED THAT "THE PLASTIC WAS BUBBLED" AND THAT THE SURGEON REPORTED THAT THE DEVICE WAS REMOVED WITH VIRTUALLY NO RESISTANCE OR EFFORT, AND THAT THE DEVICE HAD SEVERED THE PATIENT'S MEDIAL LATERAL COLLATERAL LIGAMENT. SURGEON REPORTED TO PATIENT THE DEVICE WOULD BE GIVEN TO THE STRYKER SALES REP FOR RETURN TO STRYKER. SPOKE TO SALES REP. REP REPORTED THAT HOSPITAL'S POLICY WILL NOT ALLOW THE RELEASE OF EXPLANTED DEVICES, AND THAT HE HAS NO RECOLLECTION OF HAVING RECEIVED A DEVICE FROM THE SURGEON FOR RETURN. PATIENT IS INQUIRING AS TO WHETHER THE REVISED DEVICE(S) IS/ARE SUBJECT TO ANY RECALL, AND IS INQUIRING ABOUT COMPENSATION. PATIENT DOES NOT HAVE IMPLANT INFORMATION AT THE TIME OF REPORT. UPDATE AS PER MEDICAL REVIEW"...SUSPICION THIS WAS SEVERE CASE OF ASEPTIC LOOSENING¿FEMUR HAD SOME AREAS THAT HAD BONDED WITH THE CEMENT.. TIBIA GROSSLY LOOSE.. REMOVED BY HAND¿ FEMUR AND PATELLA REMOVED WITHOUT SIG

  Patient problems: Inadequate Osseointegration; Injury; Loss of Range of Motion

  MAUDE report 8887630 ↗
• InjuryJun 26, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. THE BASEPLATE AND INSERT WERE REVISED (REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE INSERT). REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8734683 ↗
• InjuryMay 21, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT KNEE MID FLEXION INSTABILITY AND A CRUCIATE-RETAINING KNEE." UPDATE 18 OCTOBER, 2019: MEDICAL REVIEW NOTED THE FOLLOWING: REVISION DIAGNOSIS AFTER LESS THAN 5-YEARS OF IMPLANTATION WAS REPORTED AS ¿MID FLEXION INSTABILITY¿ PRIOR TO REVISION ALTHOUGH STABILITY TESTING DURING SURGERY IS MORE CONSISTENT WITH FULL FLEXION INSTABILITY. THIS MEANS THE KNEE IS (MORE OR LESS) STABLE IN EXTENSION BUT BECOMES PROGRESSIVELY MORE UNSTABLE IN AP (ANTEROPOSTERIOR) DIRECTION WITH INCREASING FLEXION. ALTHOUGH THERE ARE UNFORTUNATELY NO X-RAYS AVAILABLE AT THIS TIME TO DETAIL THE PROBLEM, THE CAUSE OF SUCH FLEXION INSTABILITY IS ALWAYS RELATED TO SUBOPTIMAL COMPONENT POSITION. CONCLUSION OF ASSESSMENT: TRIATHLON COMPONENT MALPOSITION HAS CONTRIBUTED TO AN UNEQUAL FLEXION-EXTENSION GAP SPACE IN THE KNEE TO CONTRIBUTE TO SYMPTOMATIC FLEXION INSTABILITY OF THE IMPLANTED TRIATHLON DEVICES REQUIRING REVISION SURGERY WITH BEARING EXCHANGE WITHIN 5-YEARS OF PRIMARY IMPLANTATION.

  Patient problems: Injury

  MAUDE report 8629729 ↗
• InjuryMay 1, 2019Unstable; Unstable

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY RIGHT TOTAL KNEE REPLACEMENT ARTHROPLASTY."

  Patient problems: Injury

  MAUDE report 8568809 ↗
• MalfunctionDec 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A RIGHT TKA, THE END CAP WOULD NOT UNSCREW. ANOTHER BASEPLATE WHICH WAS IMMEDIATELY AVAILABLE WAS OPENED AND USED INSTEAD. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129621 ↗
• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "OPENED IMPLANT FOR IMPLANTATION. WENT TO TAKE OFF PREASSEMBLED CAP (BABY STEM) TO PUT ON A 12X50MM CEMENTED STEM AND COULD NOT TURN OFF THE PLUG. NO ADVERSE EFFECTS BECAUSE WE DIDN'T IMPLANT." REP REPORTED THAT PROCEDURE WAS RIGHT TKA. ANOTHER IMPLANT (SAME CAT #) WAS IMMEDIATELY AVAILABLE WITH NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070107 ↗