Triathlon 5521-B-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327026337), received between Feb 16, 2018 and May 19, 2026 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Loss of Osseointegration; Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT KNEE REVISION SURGERY TODAY. THE PREVIOUS REVISION SURGERY WAS FROM ANOTHER COMPANY¿S KNEE TO STRYKER. THE REVISION TODAY WAS DUE TO PAIN AND INSTABILITY. DURING IMPLANT REMOVAL MOST OF THE DISTAL FEMUR CAME OFF WITH THE FEMORAL IMPLANT SO IT WAS NECESSARY TO GO TO A GMRS IMPLANT. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL. UPDATE ON 29 APR 2026, BASED ON MEDICAL REVIEW: TIBIA WITH LOOSENING SEEN AROUND THE TIBIAL STEM. IMPLANT HAS FALLEN INTO VARUS, AND THE MEDIAL PLATEAU IS COLLAPSED. THE TIBIAL STEM IS IMPINGING ON THE LATERAL CORTEX. FEMORAL COMPONENT NOT CLEARLY LOOSE BUT IN SIGNIFICANT EXTENSION ON THE LATERAL VIEW.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Periprosthetic fracture

  MAUDE report 25213870 ↗
• InjuryApr 28, 2025Loss of Osseointegration; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 YEARS POST-IMPLANT, THE PATIENT FELL. X-RAYS APPEAR TO SHOW THAT THE TIBIAL STEM IS NO LONGER SEATED INTO THE TIBIAL BASEPLATE. SURGEON WOULD LIKE TO SPEAK WITH A STRYKER ENGINEER TO DISCUSS HOW THIS HAPPENED. AT THE TIME OF REPORT, THE SURGEON DID NOT HAVE A REVISION SURGERY SCHEDULED. REP CONFIRMED THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME, BUT WILL REPORT IF THE PATIENT IS REVISED.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 21918532 ↗
• InjuryDec 16, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR. INTRA-OPERATIVELY, IT WAS ALSO OBSERVE THAT BOTH STEMS (TIBIAL AND FEMORAL) BROKE OFF APPROXIMATELY HALFWAY UP THEIR THREADING. THE PATIENT'S TS KNEE WAS CONVERTED TO A COMPETITOR REVISION KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20937311 ↗
• InjuryDec 4, 2024Loss of Osseointegration; Loss of Osseointegration

  COMPETITOR RECENTLY RECEIVED A REVISION OP REPORT FOR STRYKER IMPLANTS AS SUPPLEMENTAL INFORMATION THROUGH OUR COMPLAINTS REPORTING SYSTEM THAT WE WANTED TO PASS ALONG. PLEASE FIND IT ATTACHED. UPDATE 19/NOVEMBER/2024 : PER OP REPORT, REVISION WAS DUE TO LOOSE TIBIA COMPONENT. A BASEPLATE AND STEM WERE REVISED. THOUGH AN INSERT WAS NOT LISTED AS AN EXPLANT, THERE WAS ALSO A REVISION INSERT IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20840825 ↗
• InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE LEFT 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 20667141 ↗
• InjuryDec 6, 2023Malposition of Device; Malposition of Device

  THIS PI IS FOR THE SAME-DAY REVISION ON (B)(6) 2023. AS REPORTED: PLEASE FIND ATTACHED INFORMATION FROM A REVISION OF LEFT TOTAL KNEE DONE (B)(6) 2023. THERE IS ATTACHED INFORMATION FROM THE INDEX SURGERY AND A PREVIOUS REVISION. THE PREVIOUS REVISION WAS REMOVAL OF THE KNEE IMPLANTS DUE TO INFECTION AND PLACEMENT OF A TEMPORARY IMPLANT TO TREAT THE INFECTION. ON (B)(6) THE TEMPORARY IMPLANTS WERE REMOVED AND FINAL IMPLANTS WERE PLACED (FIRST USAGE SHEET FOR (B)(6) 2023). UPON CLOSING OF THE INCISION IT WAS DISCOVERED THAT THE TIBIAL IMPLANT HAD BEEN IMPLANTED IN INTERNAL ROTATION THUS MAKING THE JOINT UNSTABLE. THE INCISION WAS OPENED BACK UP AND THE TIBIA WAS REVISED. THE SECOND SHEET HAS THE FINAL TIBIAL IMPLANTS AND THE IMPLANTS THAT WERE REMOVED ARE CIRCLED ON THE FIRST SHEET. STRYKER INSTRUMENTS (INCLUDING MAKO FROM INDEX SURGERY) WERE NOT THOUGHT TO HAVE CONTRIBUTED TO ANY OF THE COMPLICATIONS.

  Patient problems: Joint Laxity

  MAUDE report 18279100 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO TIBIAL PAIN. INTRA-OPERATIVELY, THE FOLLOWING WERE OBSERVED: OSTEOLYSIS AND FRACTURE OF THE MEDIAL TIBIA, AND THE INSERT APPEARED TO HAVE BEEN PITTED. THE BASEPLATE AND INSERT WERE REVISED.

  Patient problems: Bone Fracture(s); Osteolysis; Pain

  MAUDE report 12859113 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PT. PRESENTED WITH PAIN AND LIMITED RANGE-OF-MOTION DUE TO FIBROTIC/SCAR TISSUE FORMATION. THE TIBIAL COMPONENTS WERE REVISED IN ORDER TO ADDRESS JOINT-TIGHTNESS IN BOTH THE EXTENSION AND FLEXION GAPS. ALTOGETHER, THE TIBIA-BASEPLATE, STEM, AND CORRESPONDING INSERT WERE SWAPPED OUT. THE TS CONE AUGMENT WAS NOT REMOVED, IT REMAINS IN-PLACE. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS, AND NO FURTHER INFORMATION IS AVAILABLE." THE PATIENT WAS REVISED FROM A SIZE 6 TRIATHON BASEPLATE AND STEM (IMPLANTED (B)(6) 2020) WITH A 6 X 9 MM TS INSERT (IMPLANTED (B)(6) 2020) TO A SIZE 5 TRIATHLON BASEPLATE AND STEM WITH A 5 X 9 MM TS INSERT. SPOKE TO REP: CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11029326 ↗
• InjuryJan 1, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A LOOSE TIBIA AND POSSIBLE POLY LYSIS. THE PATIENT'S TIBIAL BASEPLATE AND INSERT WERE REVISED.

  Patient problems: Inadequate Osseointegration; Injury; Osteolysis

  MAUDE report 9537184 ↗
• InjurySep 25, 2019Material Fragmentation; Osseointegration Problem; Insufficient Device Problem Information; Material Fragmentation; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF SHARP TIBIAL PAIN. THE ORIGINAL SURGICAL PLAN WAS TO PERFORM A POLY SWAP. INTRA-OPERATIVELY, THE SURGEON NOTED THE PRESENCE OF BLACK, METALLIC DEBRIS IN THE PATIENT. THE SURGEON FOUND THE TIBIAL COMPONENT WAS LOOSE AND THAT THE DEVICE HAD BROKEN AT THE STEM/ BASEPLATE JUNCTION. THE PATIENT WAS REVISED TO ANOTHER UNIVERSAL BASEPLATE WITH STEM AND INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE INSERT, AND THAT THE FEMORAL COMPONENT WAS WELL-FIXED AND NOT REVISED. REP PROVIDED PRE-REVISION X-RAYS AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9117362 ↗
• InjuryAug 23, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY CAUSED BY LOOSENING OF THE TIBIAL BASEPLATE. A SIZE 6 BASEPLATE, INSERT, AND 7 PS FEMUR WERE REVISED TO A TRIATHLON TS CONSTRUCT. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE INSERT OR FEMORAL COMPONENT, AND THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8925015 ↗
• InjuryAug 20, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE. INTRA- OPERATIVELY, SURGEON REPORTED DISSATISFACTION OVER THE LACK OF CONTACT OF CEMENT WITH THE BASEPLATE (REPORTED AS CEMENT BEING IN CONTACT WITH THE BONE, BUT NO CEMENT INTERDIGITATING WITH THE TIBIAL BASEPLATE). THE PATIENT'S KNEE CONSTRUCT WAS REVISED (NO ALLEGATIONS AGAINST THE LINER OR FEMORAL COMPONENT WERE REPORTED).

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8912763 ↗
• InjuryJul 25, 2019Unstable; Unstable

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

  Patient problems: Injury; Pain

  MAUDE report 8827731 ↗
• InjuryJul 22, 2019Osseointegration Problem; Osseointegration Problem

  TIBIA LOOSENING (LEFT KNEE JOINT).

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8811340 ↗
• InjuryJun 20, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; 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 "PERSISTENT LEFT KNEE PAIN AND PATIENT STATUS POST LEFT TOTAL KNEE ARTHROPLASTY WITH OVERHANGING TIBIAL COMPONENT."

  Patient problems: Injury; Pain

  MAUDE report 8717506 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8424763 ↗
• InjuryMar 11, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE TIBIAL BASEPLATE WAS NOTED TO BE LOOSE, AND THE FEMORAL COMPONENT BROKEN AT THE COMPONENT/STEM INTERFACE. THE BASEPLATE, FEMORAL COMPONENT, STEM, AND INSERT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER, AND THE PATIENT'S PATELLAR IMPLANT WAS NOT REVISED. PATIENT WAS REVISED TO A UNIVERSAL BASEPLATE, TS FEMORAL COMPONENT, 2 STEMS, 2 OFFSET ADAPTERS, 8 AUGMENTS, AND TS INSERT. REP WILL BE PROVIDING A PATIENT PACKET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8407465 ↗
• MalfunctionFeb 5, 2019Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT THE OUTER STERILE BLISTER WOULD NOT PEEL BACK COMPLETELY. THE INNER BLISTER WAS ATTEMPTED TO BE PEELED BACK THROUGH THE REDUCED OPENING, AND IN THE PROCESS THE DEVICE AND THE GLOVE OF AN OPERATING ROOM STAFF MEMBER WERE RENDERED UNSTERILE. REP REPORTED ANOTHER DEVICE WAS OBTAINED WITH NO SURGICAL DELAY AS THIS OCCURRED WHILE A DIFFERENT PART OF THE PROCEDURE WAS BEING PERFORMED THAT DIDN'T DEPEND ON THE DEVICE. REP RETAINED THE DEVICE AND PACKAGING, AND MAY BE ABLE TO PROVIDE A USAGE SHEET, BUT REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304721 ↗
• InjuryJan 8, 2019Loss of Osseointegration; Loss of Osseointegration

  LETTER RECEIVED FROM PATIENT'S LAWYERS ADVISING THE STRYKER TS TRIATHLON KNEE REPLACEMENT IS "DEFECTIVE AND MATERIALLY CONTRIBUTED TO... ON GOING LEFT LOWER LIMB PROBLEMS INCLUDING THE DEVELOPMENT OF A PSEUDO- TUMOUR". PATIENT IS REPORTS LEFT KNEE PROBLEMS FOLLOWING SURGERY ON THE 14/5/2012. PLEASE SEE COMMUNICATION LOG FOR DETAILS REGARDING ADDITIONAL INFORMATION. AS PER OP REPORT: COMMENTS TRIATHLON TS CEMENTED REVISION KNEE FROM AN 63 YEAR OLD MALE REVISED AFTER 4 YEARS DUE TO OSTEOLYSIS AND ALVAL (PSEUDOTUMOUR) IS PRESENTED FOR ANALYSIS. HIGH ACTIVITY LEVEL AND MEDIAL BONE LOSS AROUND THE TIBIAL COMPONENT ARE CONSIDERED CONTRIBUTORY FACTOR TO FAILURE OF THE DEVICE. FEMORAL COMPONENT: - A COMBINATION OF BONE AND FIBROUS TISSUE ONTO CEMENT MANTLE INDICATING A WELL FIXED COMPONENTS - NUMEROUS LONGITUDINAL SCRATCHES ON BEARING SURFACE - THREADED BOSS COVERED WITH ORGANIC MATERIAL AND SHOWING WEAR ON THE SURFACE IN CONTACT WITH STEM EXTENDER (FIG. 1). FEMORAL STEM EXTENDER: - CORROSION AND WEAR IN THE BASE OF THREADED TRUNNION FROM UNEVEN ENGAGEMENT WITH FEMORAL COMPONENT BOSS COVERED WITH ORGANIC MATERIAL (FIG. 2). FEMORAL STEM: - WEAR IN THE BASE OF THREADED TRUNNION FROM UNEVEN E

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

  MAUDE report 8229204 ↗
• MalfunctionDec 28, 2018Difficult to Insert; Difficult to Insert

  PRIMARY KNEE, REP WAS NOT PRESENT FOR THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON DID NOT LIKE HOW THE 'NUB' ENGAGED WITH THE BASEPLATE THREADS. SURGEON ELECTED NOT TO IMPLANT THE DEVICE. ANOTHER DEVICE (SAME CATALOG, DIFFERENT LOT) WAS OPENED AND PERFORMED AS EXPECTED. SURGERY COMPLETED SUCCESSFULLY. NO DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202440 ↗
• InjuryAug 20, 2018Migration; Migration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED AVASCULAR NECROSIS OF THE PATIENT'S TIBIA. THE TIBIAL BASEPLATE WAS REPORTED COLLAPSED MEDIALLY. EXAMINATION NOTES FROM (B)(6) 2018 STATE THAT THE PATIENT REPORTED CLICKING, DIFFICULTY WALKING, AND PAIN. THOSE NOTES ALSO REPORT GROSS VARUS DEFORMITY OF THE LEFT KNEE WITH DIABETES AS A PATIENT FACTOR. PATIENT WAS REVISED TO A TS CONSTRUCT (PATELLA WAS NOT REVISED).

  Patient problems: Ambulation or Postural Difficulties; Injury; Necrosis; Pain

  MAUDE report 7797878 ↗
• InjuryAug 15, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO A LOOSE TIBIA. A BASEPLATE, PS INSERT, 2 AUGMENTS, OFFSET, AND STEM WERE REVISED TO A TS CONSTRUCT WITH 3 AUGMENTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7784986 ↗
• InjuryJul 10, 2018Loss of Osseointegration; Loss of Osseointegration

  PROCEDURE: PATIENT UNDERWENT PRIMARY TKA (B)(6) 2017 AND RETURNED COMPLAINING OF PAIN AND INABILITY TO AMBULATE. PATIENT UNDERWENT REVISION FOR TIBIAL LOOSENING (B)(6) 2018. INDICATED REVISED COMPONENTS WERE THE FEMORAL COMPONENT AND INSERT. UPDATE 6/19/2018: AS PER PHONE CALL FROM REVISING SURGEONS' NURSE, THE TIBIAL BASEPLATE WAS LOOSE AND WAS REVISED ALONG WITH THE INSERT. THE FEMORAL COMPONENT WAS WELL FIXED AND REMAINED IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7675515 ↗
• MalfunctionFeb 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE SURGEON REPORTED THAT THE TRIATHLON TS 19MM INSERT WOULDN¿T SIT CORRECTLY IN UNIVERSAL BASE PLATE. HE FURTHER REPORTED THAT HE THEN INSERTED THE TS 16MM INSERT INTO THE UNIVERSAL BASE TIBIAL BASE PLATE, AGAIN THIS DIDN¿T SEAT PROPERLY, HE IMPACTED THE LINER AGAIN AND INSERTED THE POST AND SAID THAT HE WOULD BRING PATIENT BACK TO THEATRE NEXT DAY FOR A LINER EXCHANGE. THERE WAS A 10 MINUTE DELAY TO SURGERY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7277664 ↗