Triathlon 5551-G-381Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327014822), received between Aug 2, 2018 and Apr 2, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATELLA FAILED.

  Patient problems: Insufficient Information

  MAUDE report 11607480 ↗
• InjuryApr 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATELLA FAILED.

  Patient problems: Insufficient Information

  MAUDE report 11607479 ↗
• InjuryJan 31, 2020Fracture; Mechanical Problem; Loss of Osseointegration; Fracture; Mechanical Problem; Loss of Osseointegration

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT HAD A LOT OF PAIN, RADIOGRAPHS REVEALED PATELLA FRACTURE WITH LOOSEN COMPONENT. THEN PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION AND PATELLA WAS EXCHANGED (B)(6) 2019.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury

  MAUDE report 9652531 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON ASYM X3 PAT 38X11MM WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(6) HOSPITAL, WAS REDISTRIBUTED BY STRYKER AUSTRALIA AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT THE (B)(6) 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 8974364 ↗
• InjuryAug 13, 2019Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  PATIENT'S WIFE CALLED REPORTING PATIENT HAD LEFT KNEE REPLACEMENT SURGERY (B)(6) 2013. PATIENT BEGAN EXPERIENCING RANGE OF MOTION ISSUES AND WAS REVISED ON (B)(6) 2018. PATIENT'S WIFE REPORTS THAT REVISING SURGEON SHOWED HER AND HER HUSBAND PICTURES OF THE EXPLANTED DEVICE, AND EXPLAINED THAT "THE PLASTIC WAS BUBBLED" AND THAT THE SURGEON REPORTED THAT THE DEVICE WAS REMOVED WITH VIRTUALLY NO RESISTANCE OR EFFORT, AND THAT THE DEVICE HAD SEVERED THE PATIENT'S MEDIAL LATERAL COLLATERAL LIGAMENT. SURGEON REPORTED TO PATIENT THE DEVICE WOULD BE GIVEN TO THE STRYKER SALES REP FOR RETURN TO STRYKER. SPOKE TO SALES REP. REP REPORTED THAT HOSPITAL'S POLICY WILL NOT ALLOW THE RELEASE OF EXPLANTED DEVICES, AND THAT HE HAS NO RECOLLECTION OF HAVING RECEIVED A DEVICE FROM THE SURGEON FOR RETURN. PATIENT IS INQUIRING AS TO WHETHER THE REVISED DEVICE(S) IS/ARE SUBJECT TO ANY RECALL, AND IS INQUIRING ABOUT COMPENSATION. PATIENT DOES NOT HAVE IMPLANT INFORMATION AT THE TIME OF REPORT. UPDATE AS PER MEDICAL REVIEW"...SUSPICION THIS WAS SEVERE CASE OF ASEPTIC LOOSENING¿FEMUR HAD SOME AREAS THAT HAD BONDED WITH THE CEMENT.. TIBIA GROSSLY LOOSE.. REMOVED BY HAND¿ FEMUR AND PATELLA REMOVED WITHOUT SIG

  Patient problems: Inadequate Osseointegration; Injury; Loss of Range of Motion

  MAUDE report 8887632 ↗
• 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 8629334 ↗
• InjuryMay 1, 2019Unstable; Unstable

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY RIGHT TOTAL KNEE REPLACEMENT ARTHROPLASTY."

  Patient problems: Injury

  MAUDE report 8568772 ↗
• InjuryDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH (MW5080901) "HAVE STRYKER TOTAL KNEE REPLACEMENT IN 2015. STILL KNEE HURTS AND SWELLING. LUCENCY BETWEEN FEMORAL COMPONENT AND THE FEMORAL ON THE ANTERIOR ASPECT, RIGHT KNEE IS STILL GIVING OUT. "HALE" OSTEOPOROSIS, STILL WEARING KNEE BRACE, CANE AND WALKER. ALSO, THERE IS A SLIGHT LATERAL TILT TO THE PATELLA, STRYKER TOTAL KNEE REPLACEMENT WILL NOT STOP HURTING, WILL NOT STOP SWELLING, PAIN IS A LOT. DOCTOR SAID I NEED TOTAL KNEE REPLACEMENT."

  Patient problems: Pain; Swelling

  MAUDE report 8148710 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO MECHANICAL COMPLICATIONS. SURGEON WOULD NOT ELABORATE ON THE MECHANICAL COMPLICATIONS BUT EMPHATICALLY RULED OUT THE DEVICES HAVING CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED TO A TRIATHLON TS CONSTRUCT.

  Patient problems: Injury

  MAUDE report 7742567 ↗