Triathlon 5510-F-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327040319), received between Jul 18, 2017 and Jan 8, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Unstable; Unstable

  AS REPORTED: "REVISION TODAY WAS DUE TO INSTABILITY. TODAY THE CR FEMUR WAS REVISED TO A TS FEMUR WITH TS INSERT TO ADDRESS STABILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL." AN X-RAY AND OP REPORT EXCERPT WERE PROVIDED. LEFT KNEE. ADDITIONAL INFORMATION FROM REP: THERE WAS NO APPEARANCE OF DAMAGE TO THE POLY DURING THE CASE. THE INSTABILITY SEEMED TO BE ALL SOFT TISSUE RELATED, NOT IMPLANT FAILURE RELATED. COMPONENTS WERE WELL FIXED TO BONE AND INSERT DID NOT APPEAR TO BE WORN OR DAMAGED.

  Patient problems: Joint Laxity

  MAUDE report 21108359 ↗
• InjurySep 12, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED VIA PHONE THAT; THE PATIENT HAD A TOTAL KNEE REPLACEMENT IN (B)(6) 2019. THE WHOLE THING HAS FALLEN APART AND HAS TO BE REVISED NEXT MONTH. PAIN, FEELS IMPLANT MOVING, SWELLING. ADDITIONAL INFO. 21-AUG-2024: LOOSENING. UPDATE 09-SEP-2024: PER HOSPITAL, PATIENT IS BEING REVISED ON (B)(6) 2024 TO COMPETITOR PRODUCT.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 20200292 ↗
• InjurySep 18, 2023Material Erosion; Fracture; Material Erosion; Fracture

  DURING A KNEE REVISION, THE SURGEON NOTICED A HORIZONTAL LINE/GROOVE ON THE MEDIAL SIDE OF A #6 LEFT CR CEMENTED FEMORAL COMPONENT. THE SURGEON ALSO NOTICED EXTREME WEAR ON THE MEDIAL SIDE OF A#6 9MM CS POLY INSERT AND WEAR ON THE SYMMETRICAL 39X11MM PATELLA. WHILE REMOVING THE LEFT FEMORAL COMPONENT FROM THE PT¿S FEMUR, THE SURGEON WAS ABLE TO REMOVE THE BROKEN FEMORAL SECTION OF THE COMPONENT. FEMORAL COMPONENT, TIBIAL POLY INSERT AND THE PATELLA WERE REPLACED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17762847 ↗
• InjuryMar 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "LEFT TOTAL KNEE. REVISION WAS SECONDARY TO PATELLA DISLOCATION. THERE WAS NO MENTION OF MAKO BEING RELEVANT TO THE PATELLA DISLOCATION. NO FURTHER INFORMATION AVAILABLE FROM THE SURGEON OR HOSPITAL." SPOKE TO REP. PATELLAR DISLOCATION WAS ADDRESSED BY RE-SUTURING THE CAPSULE. WHILE IN THE KNEE, SURGEON DECIDED TO EXCHANGE A 6X9 CS INSERT FOR ANOTHER 6X9 CS INSERT. THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT. UPDATE: AS REPORTED VIA MEDWATCH MW5147161: AS REPORTED VIA MEDWATCH MW5147162: AFTER HAVING A TOTAL KNEE REPLACEMENT IN 2022 THE KNEECAP RELEASED AND HAD TO HAVE REVISION SURGERY AND NOW MY KNEECAP HAS MOVED AGAIN RESULTING IN ANOTHER REVISION SURGERY. THE SURGEON HAS RESCHEDULED ANOTHER TOTAL KNEE REPLACEMENT AGAIN TO BE DONE ON (B)(6) 2023. IS THIS BECAUSE OF A DEFECTIVE KNEE REPLACEMENT? THE BRAND OF KNEE REPLACEMENT WAS STRYKER, I'VE HEARD OF STRYKER HAVING RECALLS ON THEIR PRODUCTS.

  Patient problems: Joint Dislocation

  MAUDE report 16542069 ↗
• InjuryMay 21, 2019Unstable; Unstable

  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 8629255 ↗
• MalfunctionJan 16, 2019Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT THE TOP OF THE TRAY OF THE INNER STERILE BLISTER WAS CRACKED. SURGEON ELECTED TO NOT USE THE IMPLANT DUE TO STERILITY CONCERNS. ANOTHER IMPLANT WAS OBTAINED WITH A SURGICAL DELAY OF LESS THAN A MINUTE WHILE A TOURNIQUET WAS IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253504 ↗
• MalfunctionJan 15, 2019Packaging Problem; Packaging Problem

  AS REPORTED: "OPENED FULLY SEALED BOX AND OUTER PLASTIC SHELL WAS BROKEN. BOX SEEMS TO BE INTACT BUT DOES HAVE WRINKLES WHERE IT MAY HAVE BEEN SQUEEZED OR UNDER PRESSURE IN TRANSIT?" REP PROVIDED PICTURES OF THE PACKAGING FOR A SIZE 6 LEFT CR CEMENTED FEMORAL COMPONENT WITH ONE SIDE OF THE OUTER BLISTER'S PLASTIC TRAY BROKEN OFF THE TRAY AND ADHERED TO THE TYVEK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249543 ↗
• MalfunctionOct 15, 2018Material Discolored; Material Discolored

  THE SURGEON REPORTED THAT WHEN HE OPENED THE TIBIAL BASE PLATE AND FEMORAL COMPONENT, BOTH ITEMS WERE DISCOLORED AND DID NOT HAVE THE USUAL HIGH POLISHED APPEARANCE. THE SURGEON USED ALTERNATIVE DEVICES TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7965578 ↗
• MalfunctionOct 24, 2017Packaging Problem; Packaging Problem

  THE CUSTOMER, INFORMED THAT SHE OPENED THE PACKET OF TRIATHLON CR FEM COMP #6 L-CEM IMPLANT AND THE INNER PACKET WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6973653 ↗
• MalfunctionJul 18, 2017Packaging Problem; Packaging Problem

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE ORTHOPAEDIC THEATRE MANAGER THAT A TRIATHLON IMPLANT WAS OPENED TO FIND THAT THE OUTER PLASTIC CASING WAS SPLIT. THE INNER PLASTIC CONTAINER CONTAINING THE IMPLANT WAS INTACT, HOWEVER, THE CONSULTANT ORTHOPAEDIC SURGEON WAS NOT HAPPY TO USE IT, FEARING THE STERILITY OF THE IMPLANT WAS COMPROMISED. THE DISTRIBUTOR FURTHER REPORTED THAT THE OUTER CARDBOARD PACKAGING AND THE PLASTIC FILM WERE ALSO INTACT. THE CASE WAS COMPLETED USING A NEW IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6724010 ↗