Triathlon 5551-G-299Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327014792), received between Jul 18, 2018 and Nov 22, 2021 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. SPOKE TO REP: THE SURGEON REPORTED THAT THE PATIENT SOMEHOW 'FLIPPED' THEIR PATELLA. WHILE REPOSITIONING THE PATELLA, THE SURGEON DECIDED TO EXCHANGE A 5X12 CR SCORPIO INSERT FOR A 5X15 CR INSERT.

  Patient problems: Insufficient Information

  MAUDE report 12853770 ↗
• InjuryApr 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND SWELLING, AND DISLOCATION OF THE PATIENT'S RESURFACED PATELLA. THE TIBIAL COMPONENT AND INSERT WERE REVISED. NO INTRA-OPERATIVE FINDINGS OR SURGEON OPINION WAS REPORTED TO THE REP AS TO WHY THE TIBIA WAS REVISED. REP PROVIDED THE REVISION USAGE SHEET, CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 11730568 ↗
• InjuryApr 13, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  THE CUSTOMER REPORTED THAT HE REVISED A TRIATHLON FOR INSTABILITY AND OPENED THE KNEE TO DISCOVER THAT THE POLY INSERT HAD BROKEN WHICH HAS CAUSED THE INSTABILITY. THE PATIENT HAD A FALL IN (B)(6) 2020. THE SURGEON ALSO REPORTED THAT THE PATELLA HAD A WEAR PATTERN WHICH THE SURGEON BELIEVES IS NOT RELATED TO THE IMPLANT BEING BROKEN. THE TKR WAS INITIALLY DONE ON (B)(6) 2010.

  Patient problems: Fall

  MAUDE report 11654690 ↗
• InjuryMar 5, 2021Fracture; Fracture

  THE FOLLOWING WAS REPORTED: PATELLA BROKE AFTER PATIENT FELL.

  Patient problems: Fall

  MAUDE report 11421065 ↗
• InjuryJan 11, 2021Unstable; Unstable

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. NOTED ON THE SHEET: "REASON: KNEE PAIN, INSTABILITY." A 5X9 PS INSERT AND A29 PATELLA WERE REVISED TO A 5X11 PS INSERT AND A32 PATELLA. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS. SPOKE TO REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11152296 ↗
• InjuryNov 6, 2020Osseointegration Problem; Osseointegration Problem

  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 10799784 ↗
• InjuryNov 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY NOT REPORTED TO THE REP. A 9MM X3 PATELLA WAS SWAPPED FOR ANOTHER 9MM X3 PATELLA. REP PROVIDED THE REVISION USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9378967 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON ASYM X3 PAT 29X9MM WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(4) HOSPITAL, WAS REDISTRIBUTED BY STRYKER AUSTRALIA AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT (B)(4) 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 WG: 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 8974452 ↗
• InjurySep 5, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO A FAILED UNSTABLE LEFT KNEE REPLACEMENT.

  Patient problems: Injury

  MAUDE report 8964778 ↗
• InjuryJul 2, 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 "PERIPROSTHETIC OSTEOLYSIS, RIGHT TOTAL KNEE REPLACEMENT".

  Patient problems: Injury; Osteolysis

  MAUDE report 8753584 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY OF LEFT TOTAL KNEE ARTHROPLASTY." UPDATE 08 AUGUST, 2019: MEDICAL REVIEW HAS IDENTIFIED ADDITIONAL INFO: PRIMARY LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010, USING A TRIATHLON CR KNEE WITH 11-MM X3 CS INSERT ON A PRIMARY BASEPLATE. THE FIRST YEAR POSTOPERATIVE WENT REASONABLY WELL BUT PATIENT PRESENTED AGAIN TO SURGEON ON (B)(6) 2012, WITH PROGRESSIVE LEFT KNEE PAIN, A ¿WEAK KNEE¿ WITH FEELINGS OF GIVING WAY AND ¿POPPING¿ SENSATIONS. UPON PHYSICAL EXAMINATION ¿NO GROSS INSTABILITY¿ WAS REPORTED ALTHOUGH SUBTLE INSTABILITY SIGNS WERE STILL NOTED. A DECISION FOR REVISION WITH EXCHANGE OF THE BEARING WAS ESTABLISHED AND PERFORMED ON (B)(6) 2012, WITH EXCHANGE OF THE 11-MM CS BEARING FOR A 16-MM CS BEARING WHILE RETAINING FEMUR AND TIBIA. MED REVIEW ALSO IDENTIFIED 2 SUBSEQUENT REVISION OF THIS PATIENTS KNEE. THIS PI IS FOR REVISION OF THE PRIMARY IMPLANTED ON (B)(6) 2010 AND REVISED ON (B)(6), 2012.

  Patient problems: Injury

  MAUDE report 8752769 ↗
• 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 8631555 ↗
• InjuryApr 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY (CHRONIC PROGRESSIVE INSTABILITY)".

  Patient problems: Injury

  MAUDE report 8504158 ↗
• 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 8482469 ↗
• InjuryNov 5, 2018Unstable; Noise, Audible; Unstable; Noise, Audible

  PATIENT CALLED STATING THAT SHE HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. ON OR ABOUT (B)(6) 2013 SHE STARTED EXPERIENCING PAIN, SWELLING AND LOOSENING. UPDATE: PATIENT REPORTED THAT ONLY THE FEMORAL COMPONENT WAS REVISED. UPDATE: IT IS NOTED THAT A TRIATHLON INSERT COMPONENT WAS RETURNED TO STRYKER FOR EVALUATION; THEREFORE IT APPEARS THAT ONLY THE INSERT WAS REVISED. UPDATE: IT WAS REPORTED THROUGH MW5079852 "SEVERE SWELLING, PAIN, RIGHT KNEE CLICKING, INSTABILITY."

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8039508 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET. PATIENT WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH 8 AUGMENTS, AND AN ASSYMETRIC PATELLA.

  Patient problems: Injury

  MAUDE report 7699493 ↗