Triathlon 5531-G-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07613327045734), received between Nov 9, 2017 and Dec 17, 2025 — classified as 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Unstable; Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT TOTAL KNEE. THE REVISION TODAY WAS DUE TO HYPER EXTENSION AND INSTABILITY. THE 11 MM INSERT WAS REMOVED AND REPLACED WITH A 14 MM INSERT TO ADDRESS THE INSTABILITY AND HYPER EXTENSION. IT WAS ALSO DISCOVERED THAT THE PATELLA IMPLANT WAS SHOWING SIGNS OF WEAR. THE PATELLA WAS REVISED TO A COMPETITOR PATELLA AS THAT IS WHAT WAS AVAILABLE AT THE HOSPITAL. THIS SURGERY WAS ADDED ON LATE AND INSERTS WERE REQUESTED SO PATELLA COMPONENTS WERE NOT ORDERED IN.

  Patient problems: Joint Laxity

  MAUDE report 23830487 ↗
• InjuryNov 24, 2025Unstable; Unstable

  SURGEON REVISED A CS INSERT POLY ON A LEFT KNEE DUE TO PATIENT HYPEREXTENDING. HE WENT FROM A 3X11 TO A 3X16.

  Patient problems: Joint Laxity

  MAUDE report 23638258 ↗
• InjuryJul 29, 2025Fracture; Fracture

  "INCIDENT DESCRIPTION: REVISION FOLLOWING POLYETHYLENE BREAKAGE ON KNEE PROSTHESIS OPERATED ON IN 2016. PATIENT INFORMATION: CURRENT PATIENT STATUS: NR".

  Patient problems: Insufficient Information

  MAUDE report 22660001 ↗
• InjuryJun 30, 2024Degraded; Fracture; Degraded; Fracture

  OVER TIME PATIENT HAD LESS FLEXION AND MORE PAIN. EXPLANTED BROKEN 3X11 CS POLY.

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

  MAUDE report 19640956 ↗
• InjuryMar 1, 2024Degraded; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE FOLLOWING WERE OBSERVED: THE LOCKING WIRE OF THE INSERT BROKE, AND THE INSERT DISLODGED FROM THE BASEPLATE. THE FEMORAL COMPONENT WAS ARTICULATING POSTERIORLY, CAUSING INSERT WEAR AND METALLOSIS DUE TO ARTICULATING WITH THE BASEPLATE. THE BASEPLATE'S POSTERIOR MEDIAL PORTION WAS BROKEN OFF. PATIENT'S ACTIVITY LEVEL WAS NORMAL, NO TRAUMA REPORTED. THE PATIENT'S CR KNEE (INCLUDING PATELLAR COMPONENT) WAS CONVERTED TO A TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18814727 ↗
• InjuryOct 14, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "WE ARE DOING A POLY EXCHANGE TODAY FOR GLOBAL INSTABILITY. GOING TO THICKER POLY." A 3X11 CS INSERT WAS REVISED TO A 3X16 CS INSERT. SPOKE TO REP. INTRA-OPERATIVELY, IT WAS CONFIRMED THAT NO IMPLANTS WERE LOOSE, WORN, OR BROKEN. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15604222 ↗
• InjurySep 9, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: I HAD A TOTAL KNEE REPLACEMENT DONE AND, HAVE HAD MAJOR ISSUES WITH IT. THE PLASTICS WERE LOOSE CAUSING MY KNEE TO BUCKLE, LOCK UP, HAVE EXCESS SIDE TO SIDE MOVEMENT, CONSTANT PAIN IN MY LEFT KNEE AND, FELL DOWN STAIRS BECAUSE OF IT. I HAD A REVISION SURGERY DONE ON (B)(6) 2020, WHERE THE PLASTICS WERE REPLACED. I HAVE MADE MULTIPLE TRIPS TO MY ORTHOPEDIC DOCTOR FOR SEVERE PAIN IN MY KNEE BEFORE AND AFTER THE SECOND SURGERY WITH NO AVAIL. I AM EXTREMELY UNHAPPY WITH THE RESULTS OF THE KNEE REPLACEMENT AND NOW, SUFFER NERVE DAMAGE AND CONSTANT EXTREME PAIN IN MY LEFT KNEE. THE PAIN IN MY KNEE IS SO SEVERE THAT I CAN¿T SLEEP AT NIGHT NOR CAN I PERFORM NORMAL DAY TO DAY ACTIVITIES. THIS REPORT IS FOR REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2020.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15392924 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PAIN, SWELLING AND DIFFICULTY WALKING. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. MEDWATCH MW5111379 RECEIVED. AS REPORTED: "RECEIVED STRYKER TIBIAL X3 TRIATHLON KNEE REPLACEMENT. FDA SAFETY REPORT ID# (B)(4)." CATALOG AND LOT FOR A KNEE INSERT IS PROVIDED. THE ONLY OTHER INFORMATION PROVIDED: "OUTCOMES ATTRIBUTED TO ADVERSE EVENT: DISABILITY OR PERMANENT DAMAGE. TYPE OF EVENT: SERIOUS INJURY."

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 15337655 ↗
• InjuryJan 12, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION INSTABILITY, GLOBAL INSTABILITY, AND TIBIAL BASEPLATE SUBSIDENCE. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: THE LOCKING WIRE OF THE INSERT WAS BROKEN AT BOTH LOCKING POINTS OF THE BASEPLATE, POSTEROMEDIAL WEAR WAS NOTED ON THE INSERT, AND A PIECE OF THE INSERT (ABOUT THE SIZE OF A DIME) HAD BROKEN OFF THE POSTEROMEDIAL PORTION. THE BASEPLATE, INSERT, AND FEMORAL COMPONENT WERE REVISED TO COMPETITOR DEVICES (NO ALLEGATIONS WERE MADE AGAINST THE FEMORAL COMPONENT), THE PATELLAR COMPONENT WAS RETAINED.

  Patient problems: Joint Laxity

  MAUDE report 13235311 ↗
• InjuryDec 10, 2021Break; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Break; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  INSERT DISLOCATED POSTERIORLY DUE TO BREAKAGE (WEAR).

  Patient problems: Insufficient Information

  MAUDE report 12974797 ↗
• InjuryNov 11, 2021Unstable; Unstable

  PATIENT HAD BILATERAL STAGED INDEX TKA. PATIENT COMPLAINS OF INSTABILITY AND VALGUS DEFORMITY. RIGHT LATERAL PLATEAU COLLAPSE. UNDERGOES REVISION ON MARCH 3, 2021. ALL COMPONENTS EXCHANGED EXCEPT PATELLA.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12795112 ↗
• InjurySep 14, 2021Material Erosion; Fracture; Unstable; Material Erosion; Fracture; Unstable

  A DR HAS REPORTED A KNEE REVISION WHERE HE NEEDED TO EXCHANGE THE POLY INSERT. THE PATIENT HAD A SIZE #3/11MM CS INSERT CURRENTLY IN. UPON EXPLANT DR. NOTICED THE INSERT WAS DAMAGED POSTERIORLY ON THE MEDIAL SIDE. UPDATE: SURGEON STATED THE PATIENT WAS COMPLAINING OF PAIN AND INSTABILITY WHICH LEAD TO THE REVISION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12466420 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. HAS HAD PAIN FOR 4 MONTHS CAME IN TO THE ER YESTERDAY THEY TAPPED THE KNEE AND ITS INFECTED." SPOKE TO REP: A STAGE 1 REVISION FOR INFECTION WAS DONE ON THE PATIENT'S RIGHT KNEE. A SIZE 3 FEMORAL COMPONENT, TRIATHLON CS INSERT, TRITANIUM BASEPLATE, AND TRIATHLON PATELLA WERE REMOVED. OTHER THAN EXPLANT PICTURES, REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11571517 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A PER FORM WAS PROVIDED WITH A BLANK EVENT DESCRIPTION REPORTING A REVISION OF THE PATIENT'S KNEE. A BASEPLATE AND INSERT ARE IN THE GRID. ADDITIONAL NOTE STATES "PATIENT STATES NO FALL."

  Patient problems: Injury

  MAUDE report 9937965 ↗
• InjuryJan 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2017. PATIENT HAD SINGLE-STAGE EXCHANGE FOR INFECTION (B)(6) 2019. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9653848 ↗
• InjuryDec 23, 2019Fracture; Fracture

  IT WAS REPORTED THAT A POLY SWAP OF THE PATIENT'S RIGHT KNEE WAS PERFORMED. INTRA-OPERATIVELY, THE POSTERIOR LATERAL ASPECT OF THE INSERT WAS FOUND TO BE FRACTURED. REP WILL TRY TO OBTAIN MORE INFORMATION PERTINENT TO THE CASE, AND WILL TRY TO OBTAIN THE IMPLANT FOR RETURN.

  Patient problems: Injury

  MAUDE report 9512540 ↗
• MalfunctionOct 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, RIGHT KNEE. AFTER IMPACTION, THE LOCKING WIRE OF THE 3X11 CS INSERT WAS FOUND OUT OF THE IMPLANT. SURGEON ALLEGES THAT THE WIRE WAS LOOSE IN THE IMPLANT PRIOR TO IMPACTION. ANOTHER 3X11 CS INSERT (SAME CATALOG, DIFFERENT LOT) WAS OBTAINED AND WAS IMPLANTED WITHOUT ISSUE. THERE WAS A SURGICAL DELAY OF LESS THAN A MINUTE WITHOUT USE OF TOURNIQUET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221086 ↗
• InjuryOct 14, 2019Unstable; Noise, Audible; Unstable; Noise, Audible

  AS REPORTED: "PAIN, INSTABILITY, CLICKING. ALL AVAILABLE INFORMATION SUBMITTED". REP PROVIDED PRE-REVISION X-RAYS, PRIMARY OPERATIVE REPORT, AN IMPLANT REPORT, AND EXPLANT PICTURE FOR REVISION OF THE PATIENT'S LEFT KNEE. A 3X11 CS INSERT WAS REVISED TO A 3X16 CS INSERT.

  Patient problems: Injury; Pain

  MAUDE report 9184986 ↗
• InjuryOct 1, 2019Break; Unstable; Naturally Worn; Break; Unstable; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, THE 3X11 CS INSERT WAS OBSERVED TO BE BROKEN POSTERIORLY ON THE MEDIAL AND LATERAL ASPECT OF THE DEVICE. THE INSERT WAS REVISED. THE REVISED DEVICE WILL BE RETURNED AND THE REP PROVIDED 1 PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9141866 ↗
• InjuryJul 25, 2019Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PAIN, GROSS INSTABILITY, MECHANICAL COMPLICATION AND SIGNIFICANT POLYETHYLENE WEAR AND DAMAGE OF LEFT TOTAL KNEE."

  Patient problems: Injury; Pain

  MAUDE report 8828103 ↗
• InjuryJun 19, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO MALALIGNMENT AND INSTABILITY".

  Patient problems: Injury

  MAUDE report 8712656 ↗
• InjuryJun 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED.

  Patient problems: Injury

  MAUDE report 8686827 ↗
• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH CATASTROPHIC POLYETHYLENE FAILURE".

  Patient problems: Injury

  MAUDE report 8633082 ↗
• InjuryMay 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO UNKNOWN REASON. CS INSERT, FEMORAL COMPONENT AND A CANCELLOUS BONE SCREW WERE REVISED. REP REPORTED NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8588474 ↗
• InjuryMar 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN NOT REPORTED TO REP. A 3 X 11 CS INSERT AND SIZE 3 CR FEMORAL COMPONENT WERE REVISED TO A SIZE 2 TS FEMORAL COMPONENT WITH STEM AND 2 AUGMENTS, A 3X11 PS INSERT, AND A BONE PLUG.

  Patient problems: Injury; Pain

  MAUDE report 8430375 ↗