Triathlon 5512-F-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327026597), received between Mar 20, 2017 and Aug 18, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Fracture

  It was reported that the patient's left knee was revised due to the following: Loosening of the femoral stem and breakage of the femoral stem where it threads into the femoral component, loosening of the tibial stem which was also broken. The TS knee was removed and another TS knee implanted with a revision baseplate, stems and cones. Rep can provide images, otherwise confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50303259 ↗
• InjuryDec 19, 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 20978444 ↗
• InjuryMay 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. THE PATIENT'S FEMORAL COMPONENT, STEM, AUGMENTS, AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP ALSO PROVIDED THE USAGE SHEET FROM THE PRIOR SURGERY, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10066286 ↗
• InjuryApr 17, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY NOT REPORTED TO REP. THE PATIENT'S FEMORAL SIDE AND TIBIAL INSERT WERE REVISED. REP PROVIDED USAGE SHEET FROM CURRENT AND PREVIOUS SURGERIES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury

  MAUDE report 9973726 ↗
• InjuryJan 8, 2019Material Deformation; Material Deformation

  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 (B)(6) 2012. PLEASE SEE COMMUNICATION LOG FOR DETAILS REGARDING ADDITIONAL INFORMATION. AS PER OP REPORT: COMMENTS: TRIATHLON TS CEMENTED REVISION KNEE FROM (B)(6) 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 ENGAG

  Patient problems: Cyst(s); Fibrosis; Inadequate Osseointegration; Injury

  MAUDE report 8229581 ↗
• InjurySep 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED IN AN ATTEMPT TO TIGHTEN THE FLEXION GAP. REP REPORTED THE NEED FOR REVISION WAS DUE TO THE PATIENT'S NEUROLOGICAL CONDITION WHICH LIMITS AMBULATION TO CRAWLING AROUND, AND THAT THERE ARE NO ALLEGATIONS AGAINST ANY STRYKER DEVICES. A SIZE 6 FEMORAL COMPONENT WITH A 15X50 CEMENTED STEM WAS REVISED TO A SIZE 7 FEMORAL COMPONENT WITH A 12X50 CEMENTED STEM. REP CANNOT CONFIRM THE USE OF STRYKER CEMENT BUT REPORTED THE FACILITY HAS A CONTRACT WITH A COMPETITOR "FOR CEMENT PRODUCTS AND USES THEM FOR MOST ALL CEMENTED CASES".

  Patient problems: Ambulation or Postural Difficulties; Injury; Neurological Deficit/Dysfunction

  MAUDE report 7915611 ↗
• 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 7715252 ↗
• InjuryJun 6, 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 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 7574398 ↗
• InjuryJun 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  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 7566056 ↗
• InjuryMay 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7529233 ↗
• MalfunctionMar 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THERE WAS DIFFICULTY ENGAGING THE 5MM FEMORAL POSTERIOR AUGMENT BOLT INTO THE SIZE 6 TS FEMORAL COMPONENT USING THE SLIP TORQUE HEX SCREWDRIVER. IT WAS FIRST ATTEMPTED BY THE SCRUB NURSE AND EVENTUALLY INSERTED BY THE SURGEON. THE SURGEON APPLIED CEMENT AROUND THE AUGMENT, FOR SECURITY, AND THE DEVICE WAS THEN IMPLANTED INTO THE PATIENT. THE CUSTOMER ALSO REPORTED THAT THE BOLT WAS USED TO SECURE THE AUGMENT USING SCREWDRIVER AND MORE TORQUE WAS REQUIRED THAN NORMAL. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6419657 ↗