Triathlon 5510-F-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07613327040265), received between Jan 29, 2018 and Jul 27, 2026 — classified as 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Use of Device Problem

  The following information was provided: During a knee replacement procedure, a femoral component with the opposite laterality to that required for the patient was opened and implanted. The event was attributed to human error during the verification, product opening, and surgical assistance processes performed by the hospital's surgical staff.It was confirmed that neither the Mako System nor the implanted device exhibited any quality defect, malfunction, or performance-related issue that contributed to the event.Following identification of the error, a second surgical procedure was scheduled and performed on the same day, approximately four hours later, to implant the appropriate knee revision prosthesis based on the patient's clinical needs. The incorrect femoral component was removed and replaced with the appropriate revision implant.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 50035579 ↗
• InjuryOct 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A RIGHT-SIDED FEMORAL COMPONENT WAS IMPLANTED IN THE PATIENT'S LEFT KNEE. DISCOVERY WAS MADE AND REVISION WAS PERFORMED THE SAME DAY AS IMPLANTATION. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 23346448 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP OF A RIGHT MAKO TKA, PATIENT FELL AND SUSTAINED A FEMORAL FRACTURE. AN IM NAIL WAS IMPLANTED, NOTHING WAS REMOVED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 17494207 ↗
• InjuryJun 12, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE POSTERIOR CAPSULE OF THE KNEE WAS STRETCHING OUT TO THE POINT WHERE IT BEGAN TO ENTER HYPERFLEXION. A CR FEMUR AND CS INSERT WERE REVISED TO CONVERT THE PATIENT TO A PS KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17103175 ↗
• InjuryNov 7, 2022Use of Device Problem; Use of Device Problem

  A PATIENT HAD BEEN PREPPED FOR A RIGHT CEMENTLESS KNEE REPLACEMENT. A CEMENTED FEMUR WAS OPENED BY A COWORKER ON ACCIDENT AFTER BEING APPROVED BY BOTH THE SURGEON AND THE CIRCULATOR AND IMPLANTED INTO THE PATIENT. THE PATIENT WAS THEN CLOSED AND SENT TO THE FLOOR BEFORE WE REALIZED WHAT HAD HAPPENED. THE PATIENT THEN HAD TO BE BROUGHT BACK TO THE OPERATING ROOM AND THE INCORRECT CEMENTED FEMORAL COMPONENT WAS REPLACED BY A CEMENTLESS FEMORAL COMPONENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743061 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION, TIGHTNESS AND STIFFNESS. THE SURGEON REVISED THE TRIATHLON CR FEMORAL COMPONENT TO A PS, THE PATELLA AND POLY. THE BASEPLATE WAS NOT REVISED.

  Patient problems: Loss of Range of Motion

  MAUDE report 14071299 ↗
• InjuryOct 14, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  SALE REP WAS INFORMED BY DOCTOR THAT THERE IS A REMOVAL SURGERY PLAN ON 28TH JUNE DUE TO INFECTED IMPLANT. UPDATE AS PER MED REVIEW DATED 19 SEPTEMBER 2021: UNDATED: RIGHT AP/LATERAL KNEE X-RAYS. GROSS LOOSENING OF TIBIA AND FEMUR. TIBIA WITH CATASTROPHIC FAILURE AND PROXIMAL TIBIAL FRACTURE. CONFIRMATION: A REVISION SURGERY AND INFECTION CANNOT BE CONFIRMED. CATASTROPHIC FAILURE AND COLLAPSE OF A TRIATHLON IMPLANT CONSTRUCT FEMUR AND TIBIA CAN BE CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 12632830 ↗
• InjuryOct 8, 2021Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PRIMARY LEFT MAKO KNEE, A RIGHT-SIDED FEMORAL COMPONENT WAS IMPLANTED. THE REP READ OFF AND HANDED THE NURSE THE IMPLANT, WHO OPENED IT AT THE BACK TABLE. THE NURSE OPENED AND READ OFF THE IMPLANT TO THE SCRUB TECH, WHO THEN OPENED THE IMPLANT TO THE FIELD (IT IS UNKNOWN IF THE SCRUB TECH READ IT OFF). DISCOVERY WAS MADE POST-OPERATIVELY. CURRENT SURGICAL PLAN IS TO OBSERVE AND ASSESS, WITH THE PATIENT'S AGREEMENT AS THE PATIENT IS PAIN FREE. REP PROVIDED THE USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597856 ↗
• InjurySep 24, 2021Use of Device Problem; Use of Device Problem

  AFTER EXPOSURE, HIP CENTER THROUGH TRIALING WERE COMPLETED IN DR¿S PREFERRED ORDER/METHOD. THERE WERE NO MAKO RELATED ISSUES THROUGHOUT THE PROCEDURE. AFTER TRIALING, DR. REQUESTED THE FOLLOWING CEMENTED COMPONENTS: FEMUR: SIZE 3 CR, TIBIA: SIZE 2, POLY: SIZE 2X 10 MM, PATELLA: SIZE A35. I RETRIEVED THE IMPLANTS AND HELD THEM UP FOR DR., THE SCRUB TECH AND THE CIRCULATOR TO SEE. I PROCEEDED TO READ EACH IMPLANT BOX: ¿TWO BY 10 POLY. THREE RIGHT CR CEMENTED FEMUR, TWO CEMENTED BASEPLATE AND AN A35 CEMENTED PATELLA.¿ DR. THEN SAID, ¿YES.¿ I SHOWED THE CIRCULATOR THE BOXES AND READ THE EXPIRATION DATES. THE IMPLANTS WERE OPENED AND GIVEN TO THE STERILE FIELD. DR. CEMENTED EACH COMPONENT. AFTER THE SUBMISSION OF THE CHARGE SHEET TO JR REP, THE WRONG FEMUR SIDE WAS IDENTIFIED. ONCE JR REP IDENTIFIED THE WRONG FEMUR SIDE WAS IMPLANTED- HE MADE CONTACT WITH THE SURGEON.¿ SPOKE TO MPS. IMPLANTS WERE OBTAINED FROM A CART WITH MULTIPLE COMMON OPTIONS FOR KNEE IMPLANTS. MPS CONFIRMED THAT AFTER TRIALING, THE SURGEON REMOVED THE ARRAYS AND DID NOT EVALUATE THE KNEE AFTER FINAL IMPLANTS WERE IMPLANTED. SPOKE TO JR REP. ONCE SURGEON WAS NOTIFIED, PATIENT WAS RETURNED TO THE OPERATING ROOM. LATER

  Patient problems: Insufficient Information

  MAUDE report 12530265 ↗
• InjuryAug 10, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT REMAINED SYMPTOMATIC AND ON (B)(6) 2011 UNDERWENT A PROCEDURE TO CORRECT PATELLA MALTRACKING AND A MANIPULATION. A LATERAL RELEASE WAS PERFORMED AND THE SURGEON STATES THAT HE WATCHED IT TRACK ¿NICELY¿ OVER THE TROCHLEAR. SOFT TISSUE RELEASES ON THE MEDIAL SIDE WERE CARRIED OUT BECAUSE HE FELT THAT WHEN THE LATERAL SIDE HEALED IT WILL HEAL IN ELONGATED POSITION [THIS IS HIS OPINION - NOT A RECOGNIZED PHENOMENON]. AFTER MANIPULATION RANGE OF MOTION WAS -5 TO 120°.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 12299335 ↗
• InjuryJul 14, 2021Unstable; Unstable

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2008 WHERE SHE WAS IMPLANTED WITH A STRYKER KNEE SYSTEM. IT IS FURTHER ALLEGED THAT THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE SURGEON NOTES THAT "EXAMINATION OF THE POLYETHYLENE LINER AFTER REMOVAL SHOWED COMPLETE WEAR OVER THE POSTERIOR ASPECTS OF BOTH MEDIAL AND LATERAL ASPECTS OF THE POLYETHYLENE LINER." UPDATED AS PER MEDICAL REVIEW , ON (B)(6) 2017 IT WAS NOTED THAT A "REVISION RIGHT TKA" WAS PERFORMED FOR A PRE- AND POST­OPERATIVE DIAGNOSIS OF "FAILED RIGHT TKA". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A 120 MINUTE TOURNIQUET TIME. THE OPERATIVE REPORT NOTES, " RADIOGRAPHS, PARTIAL POSTERIOR SUBLUXATION OF FEMUR ON TIBIA, WITH INSTABILITY , " AND ", POLYETHYLENE LINER . COMPLETE WEAR OVER THE POSTERIOR ASPECTS OF BOTH MEDIAL AND LATERAL .

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 12164845 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIGHTNESS IN FLEXION. A SIZE 3 CR FEMORAL COMPONENT AND 3 X 9 CR INSERT WERE REVISED TO A SIZE 2 FEMORAL COMPONENT AND 3 X 9 CS INSERT. REP CONFIRMED THAT OTHERWISE NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 11327862 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2017 THE PATIENT UNDERWENT A RIGHT SIDED TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT WITH GENTAMICIN AND TRIATHLON KNEE SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2020 SHE HAD TO UNDERGO A REVISION SURGERY DUE TO MECHANICAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10799786 ↗
• InjuryOct 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE SIZE 3 BASEPLATE, SIZE 3 R CR FEMORAL COMPONENT, AND 3 X 13 CR TIBIAL INSERT WERE REVISED TO A TS KNEE. THE PATELLA WAS NOT REVISED. THE REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10723084 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. AS REPORTED BY REP: "REVISED FOR PAIN AND LOOSENING. NO ALLEGATIONS AGAINST THE IMPLANTS. PATIENT HAS AVASCULAR NECROSIS WHICH CAUSED THE FAILURE." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Pain

  MAUDE report 9929454 ↗
• InjuryDec 4, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2019 A CEMENTED CR FEMORAL COMPONENT WAS IMPLANTED WITHOUT CEMENT. NO STRYKER REP WAS PRESENT FOR THE PROCEDURE. DISCOVERY WAS MADE (B)(6) 2019 WHEN THE REP NOTED AN INVENTORY DISCREPANCY. FURTHER INVESTIGATION IDENTIFIED THE CASE IN WHICH THE COMPONENT WAS USED, AND THE FACT THAT NO CEMENT WAS USED. THE SURGEON WAS NOTIFIED AND THE PATIENT WAS REVISED ON (B)(6) 2019. REP PROVIDED THE PRIMARY USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9412274 ↗
• InjuryNov 18, 2019Unstable; Unstable

  IT WAS REPORTED BY THE SALES REP THAT PATIENT REPORTED TO SURGEON THAT EXPERIENCE LIGAMENT LAXITY AND INSTABILITY. INITIAL PLACEMENT OF IMPLANT WAS APPROPRIATE. SURGEON TRIALLED WITH A THICKER INSERT (13, 16MM) WHICH WAS STABLE IN EXTENSION BUT TOO TIGHT IN FLEXION. HENCE, SURGEON OPTED FOR CHANGE TO COMPETITOR HINGE TO ENSURE EXTENSION-FLEXION STABILITY AND ALSO TO MAKE SURE THAT PATIENT DOES NOT GO INTO RECURVATUM (STRYKER TRIATHLON DOES NOT HAVE A HINGE). OLD TRIATHLON IMPLANT (DONE ON (B)(6) 2017) WAS RETURNED TO PATIENT.

  Patient problems: Injury

  MAUDE report 9335144 ↗
• InjuryNov 6, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO AN UNSTABLE RIGHT KNEE PROSTHESIS WITH RECURRENT PATELLAR DISLOCATIONS.

  Patient problems: Injury

  MAUDE report 9285811 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN PERFORMED A PRIMARY TOTAL KNEE ON PATIENT. WHILE BACK IN PACU, THE PATIENT X-RAY SHOWED THE KNEE WAS DISLOCATED AND THE PHYSICIAN BROUGHT THE PATIENT BACK AND REVISED THE KNEE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9079700 ↗
• MalfunctionSep 9, 2019Moisture Damage; Device Contamination with Chemical or Other Material; Moisture Damage; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON-CR FEM CEMENT #3 RT WHICH WAS EXPOSED TO WATER AND STEAM AT HOSPITAL, WAS REDISTRIBUTED BY STRYKER AUSTRALIA AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT HOSPITAL. A FULL LOAN TRIATHLON IMPLANT SET WAS ACCIDENTALLY RETRIEVED FROM A HOSPITAL BY A COURIER AND WAS RETURNED TO A STRYKER KIT ROOM. HOWEVER, THE COURIER WAS UNAWARE THAT THE ITEMS WERE AFFECTED AND THEREFORE DID NOT COMMUNICATE TO THE KIT ROOM THAT THESE PARTS WERE PREVIOUSLY QUARANTINED AT THE HOSPITAL. AS A RESULT THE KIT ROOM DID NOT PROCEED WITH ANY QUARANTINE ACTION AND 18 OF THE AFFECTED ITEMS WERE RE-DISTRIBUTED. UPDATE 19/AUGUST/2019: NONE OF THE PACKAGING WAS RETAINED FROM THE IMPLANTED DEVICES. SURGEONS EXPRESSED NO CONCERN, AND HAVE COMMUNICATED NO PLANS TO SURGICALLY ADDRESS THE IMPLANTATION OF THE DEVICES. TO DATE, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THESE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974441 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GROSS INSTABILITY STATUS POST PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury; Joint Laxity

  MAUDE report 8717110 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT KNEE PROSTHESIS INSTABILITY".

  Patient problems: Injury

  MAUDE report 8715932 ↗
• InjuryMay 22, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE REPLACEMENT, TIBIAL LOOSENING AND INSTABILITY".

  Patient problems: Injury

  MAUDE report 8631557 ↗
• InjuryApr 4, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE RIGHT TOTAL KNEE RULE OUT SEPTIC LOOSENING."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8482409 ↗
• InjuryMar 29, 2019Unintended Movement; Unintended Movement

  AS REPORTED "PROGRESSIVE PAIN AND SWELLING OVER LAST YEAR. ELEVATED CELL COUNT AND APPEARANCE OF INFECTION, BUT POLY WEAR MUCH MORE AGGRESSIVE WEAR THAN WOULD EXPECT". EVENT UPDATE PER REVIEW OF X-RAY BY CONSULTING CLINICIAN STATING "PROVIDED X-RAY CONFIRMS A SUBLUXATED FEMORAL COMPONENT."

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 8466212 ↗