Triathlon 5521-B-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327026320), received between Apr 20, 2018 and Feb 2, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT IS STATUS POST FOR A REVISION OF A LTKA, DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT. NO ADDITIONAL DETAILS TO BE REPORTED BY THE FACILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24240515 ↗
• InjuryJan 26, 2026Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: "RE-REVISION PROCEDURE OF TRIATHLON TS. REPLACEMENT DEVICE COMPETITOR REVISION SYSTEM".

  Patient problems: Insufficient Information

  MAUDE report 24184045 ↗
• InjuryJul 15, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION OF TIBIAL BASEPLATE DUE TO ASEPTIC LOOSENING TIBIAL COMPONENT FAILURE: REF: 5520-B-500 LOT: LMF229. IMPLANTED (B)(6) 2023. REVISION SURGERY HAD TO BE COMPLETED ON THE (B)(6) 2025 TO REMOVE THE LOOSENED BASEPLATE AND IMPLANT A NEW ONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22511522 ↗
• InjuryDec 16, 2024Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PT. CALLED TO REPORT THAT THEY HAD A PROCEDURE ON (B)(6) 2023 WITH STRYKER IMPLANTS ON THEIR LEFT KNEE. THEY STATED THAT THEY EXPERIENCED LOOSENING AND SOME OF THE IMPLANT FAILED. ADDITIONAL INFO. 27-NOV-2024: REVISION ON (B)(6) 2023.

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

  MAUDE report 20948121 ↗
• InjurySep 10, 2023Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  LEFT KNEE REVISION DUE TO TIBIAL LOOSENING AND PAIN.

  Patient problems: Implant Pain

  MAUDE report 17717011 ↗
• InjuryAug 25, 2023Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  PATIENT HAD A FALL, RUPTURED EXTENSOR MECHANISM AND LOOSENING OF THE TIBIAL COMPONENT. IMPLANTS REMOVED, CEMENT SPACER IMPLANTED. RIGHT TRIATHLON. SALES REPS RESPONSE CONFIRMS THAT ALL DEVICES WERE REMOVED.

  Patient problems: Fall; Inadequate Osseointegration; Rupture

  MAUDE report 17627373 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  PATIENT HAD A RIGHT TKA OUTSIDE CORS SCOPE AND THEN WAS REVISED IN (B)(6) 2017 OUTSIDE OF CORS SCOPE. IN (B)(6) 2020 THE PATIENT IS REVISED AGAIN, NOW ENTERING CORS REGISTRY. PATIENT DEVELOPS PAIN AND REQUIRES A SECOND REVISION ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13652115 ↗
• InjuryOct 20, 2021Malposition of Device; Malposition of Device

  SURGEON NOT HAPPY WITH OUTCOME OF SURGERY. PT STARTED IN VALGUS ENDED UP IN VARUS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12665052 ↗
• InjuryApr 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND SWELLING, AND DISLOCATION OF THE PATIENT'S RESURFACED PATELLA. THE TIBIAL COMPONENT AND INSERT WERE REVISED. NO INTRA-OPERATIVE FINDINGS OR SURGEON OPINION WAS REPORTED TO THE REP AS TO WHY THE TIBIA WAS REVISED. REP PROVIDED THE REVISION USAGE SHEET, CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 11730567 ↗
• InjuryApr 22, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PREOP DIAGNOSIS: LEFT TOTAL KNEE ARTHROPLASTY ASEPTIC LOOSENING." A TIBIAL BASEPLATE, STEM, AND INSERT WERE REVISED. SALES REP CONFIRMED THAT 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 11705296 ↗
• InjuryFeb 2, 2021Material Erosion; Fracture; Material Erosion; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. THE 'FEMALE PORTION' OF THE BASEPLATE BROKE WHERE THE THREADED PORTION OF THE STEM IS. A PORTION OF THE THE THREADED PORTION BROKE OFF. A 17 X 100 TRIATHLON FLUTED STEM AND SIZE 5 TS BASEPLATE WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Inflammation

  MAUDE report 11268070 ↗
• InjuryFeb 1, 2021Unintended Movement; Unintended Movement

  AS REPORTED: "PATIENT'S TIBIA WAS REVISED DUE SUBSIDENCE OF THE TIBIAL BASEPLATE. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS. NO FURTHER INFO AVAILABLE." THE PATIENT'S LEFT KNEE WAS REVISED. A TRIATHLON SIZE 5 BASEPLATE AND TS INSERT WERE REVISED TO A TRIATHLON SIZE 6 BASEPLATE AND TS INSERT WITH A SYMMETRIC CONE AUGMENT AND FLUTED STEM. SPOKE TO REP: CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE INSERT. SURGEON FELT THAT THERE WAS NOT ENOUGH COVERAGE OF THE TIBIA WITH THE SIZE 5 AND SIZED UP BOTH THE BASEPLATE AND THE INSERT. CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 11261257 ↗
• InjuryJan 8, 2020Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PRE-OP DIAGNOSIS WAS FOR SUSPECTED LOOSENING OF THE TIBIAL BASEPLATE. A PRE-OP X-RAY ALSO REVEALED THAT THE BOTTOM NUB OF THE BASEPLATE HAD BECOME UNTHREADED FROM THE BASEPLATE. INTRA- OPERATIVELY, LOOSENING OF THE FEMORAL COMPONENT WAS ALSO NOTED. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A TS KNEE WITH STEMS, CONES, AND AUGMENTS. THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury

  MAUDE report 9566581 ↗
• InjuryAug 9, 2019Unstable; Unstable

  THIS PI IS FOR THE LEFT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT AND LEFT KNEE POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WITH INSTABILITY.

  Patient problems: Injury

  MAUDE report 8879985 ↗
• InjuryAug 9, 2019Unstable; Unstable

  THIS PI IS FOR THE RIGHT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT AND LEFT KNEE POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WITH INSTABILITY.

  Patient problems: Injury

  MAUDE report 8878772 ↗
• InjuryJun 19, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8712737 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED THAT HIS INITIAL KNEE SURGERY WAS DONE ON (B)(6) 2017. HE HAS BEEN EXPERIENCING PAIN AND SURGICAL ISSUES FOR THE PAST 13 MONTHS SINCE HIS SURGERY WHICH LED TO A REVISION ON (B)(6) 2018. **UPDATE AS PER MEDICAL REVIEW RECEIVED STATED THAT " ON (B)(6) 2018 A NOTE STATES, "WILL UNDERGO REVISION RIGHT TKA ... FOR SEVERE NICKEL ALLERGY ...". ON (B)(6) 2018 A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, FEMUR AND TIBIA, WAS PERFORMED."

  Patient problems: Arthritis; Injury; Loss of Range of Motion; Pain; Rash; Reaction

  MAUDE report 7975804 ↗
• InjuryJul 25, 2018Malposition of Device; Malposition of Device

  PATIENT'S LEFT KNEE DISLOCATED AND WAS TREATED WITH CLOSED REDUCTION UNDER ANESTHESIA (B)(6) 2017. PER EXAM NOTES: "[PATIENT] STATES THAT HE WAS IN HIS RECLINER AGAIN WHEN HIS KNEE POPPED OUT OF PLACE AGAIN THIS MORNING. HE HAS NOT BEEN IN HIS KNEE IMMOBILIZER SINCE APPROXIMATELY ONE WEEK AGO". OPERATIVE REPORT INDICATES "...WHO HAD A DISLOCATION APPROXIMATELY 2 WEEKS AGO [EVENT REPORTED FOR (B)(6) 2017] THAT WAS CLOSED REDUCED. HE WORE A KNEE IMMOBILIZER FOR A WEEK, AND THEN TODAY, HE WAS SITTING IN HIS CHAIR WITH HIS LEG IN AN AWKWARD POSITION, FLEXED IT, AND IT DISLOCATED AGAIN...". SUBSEQUENT IMAGING REPORTED "BOTH AP AND LATERAL PLANES REVEALED ACCEPTABLE REDUCTION OF THE KNEE REPLACEMENT".

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7717953 ↗
• InjuryJul 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT'S LEFT KNEE DISLOCATED AND WAS TREATED WITH CLOSED REDUCTION UNDER ANESTHESIA (B)(6) 2017. PER EXAM NOTES: "PATIENT STATES THAT HE WAS IN HIS RECLINER THIS MORNING AND WHEN HE WENT TO GET UP HIS KNEE POPPED, IMMEDIATE PAIN, AND CAN NOT BEAR WEIGHT...HE ALSO TWISTED HIS ANKLE LAST WEEK..." PATIENT WAS DUE TO GO TO THE HOSPITAL TO ADDRESS THE TWISTED ANKLE THE AFTERNOON OF THE DAY HE DISLOCATED. OPERATIVE REPORT INDICATES DISLOCATION WAS WITHOUT FRACTURE AND THAT IN PERFORMING THE CLOSED REDUCTION, A "PALPABLE POP" WAS NOTED WITH FLUOROSCOPY REVEALING "ACCEPTABLE REDUCTION OF THE KNEE DISLOCATION BOTH IN AP AND LATERAL PLANES".

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 7717950 ↗
• InjuryJul 25, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO DISLOCATION. REP REPORTED THAT NO LIGAMENT DAMAGE WAS REPORTED. THE POST OF THE INSERT WAS NOT LOCKED IN TO THE BOX OPENING OF THE FEMORAL COMPONENT. AS PER CONSULTING CLINICIAN'S MEDICAL REVIEW, "THE MEDIAL POSITION OF THE REVISION TIBIAL COMPONENT AND THE DISTAL POSITION OF THE JOINT LINE IN THE REVISION TOTAL KNEE ARTHROPLASTY LIKELY RESULTED IN INCREASED STRESS TO THE TS INSERT STABILITY RESULTING IN TWO DISLOCATIONS AND A LATER ANTERIOR IMPLANT SUBLUXATION." THE CONSULTING CLINICIAN CLARIFIED THAT THIS CONCLUSION REFLECTS AN ALIGNMENT ISSUE OF THE TIBIAL BASEPLATE AND FEMORAL COMPONENT LEADING TOWARD SUBSEQUENT SUBLUXATION AND DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7717947 ↗
• InjuryJul 24, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A POLY SWAP WAS PERFORMED. AS PER CONSULTING CLINICIAN'S MEDICAL REVIEW, "THE MEDIAL POSITION OF THE REVISION TIBIAL COMPONENT AND THE DISTAL POSITION OF THE JOINT LINE IN THE REVISION TOTAL KNEE ARTHROPLASTY LIKELY RESULTED IN INCREASED STRESS TO THE TS INSERT STABILITY RESULTING IN TWO DISLOCATIONS AND A LATER ANTERIOR IMPLANT SUBLUXATION." THE CONSULTING CLINICIAN CLARIFIED THAT THIS CONCLUSION REFLECTS AN ALIGNMENT ISSUE OF THE TIBIAL BASEPLATE AND FEMORAL COMPONENT LEADING TOWARD SUBSEQUENT SUBLUXATION AND DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7715158 ↗
• MalfunctionApr 20, 2018Failure to Align; Failure to Align

  SIZE #5 BASEPLATE AND AUGMENT DIDN'T SIT FLUSH TOGETHER. WHEN AUGMENT USED WITH A REPLACEMENT BASEPLATE (#5), AUGMENT AND BASEPLATE SAT PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446861 ↗