Triathlon 5552-L-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327013559), received between Aug 23, 2018 and Jun 9, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: DR. INFORMED THAT ONCE HE PREPPED THE PATELLA, THE TRIAL WAS SITTING EXACTLY WHERE HE PLANNED. HOWEVER, WHEN HE WENT TO PUT IN THE IMPLANT HE NOTICED THAT IT WAS NOT SITTING WHERE THE TRIAL WAS - IT WAS 2MM MORE MEDIAL. ADDITIONAL INFORMATION: YES, THE IMPLANT WAS USED AND HE DID PRESS-FIT. IT WAS SEATED COMPLETELY AND CORRECTLY ¿ HE INFORMED IT WAS THE PLASTIC PART ITSELF THAT WAS OVERHANGING ABOUT 2MM MORE MEDIAL AND UNDERHANGING ABOUT 2MM LATERAL COMPARED TO THE TRIAL. THERE ARE NO IMAGES AVAILABLE AT THIS TIME. IT WOULDN¿T BE MENTIONED IN HIS OP REPORT ¿ HE TRIMMED THE PATELLA TO ENSURE IT WOULD BE TRACKING CENTRALLY AFTER IMPLANTING AND NOTICING THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 25443048 ↗
• InjuryDec 3, 2025Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF THE PATELLAR COMPONENT, AND DISLOCATION. A CR/ CS KNEE WAS CONVERTED TO TRIATHLON HINGE, AND THE PATELLAR COMPONENT WAS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 23708750 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED THE TIBIAL INSERT ON A TRIATHLON LEFT KNEE DUE TO PATELLA FRACTURE. HE REMOVED A PIECE OF LOOSE BONE FRAGMENT AND WHILE IN THERE, DECIDED TO CHANGE THE INSERT FROM A 4X10 TO A 4X9. NO ALLEGATIONS MADE AGAINST THE IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 18967150 ↗
• InjuryDec 12, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO MECHANICAL FAILURE (LOOSENING) OF THE PATELLAR COMPONENT. THE PATELLAR COMPONENT WAS REPLACED WITH A CEMENTED PATELLAR COMPONENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18313643 ↗
• InjuryNov 21, 2023Loss of Osseointegration; Loss of Osseointegration

  PATIENT WOULD LIKE TO KNOW IF RIGHT KNEE IMPLANTS ARE SUBJECT TO A RECALL. PATIENT NOTED LOOSENING. 27-NOV-2023: UPDATE PER CONVERSATION WITH PATIENT: PATIENT REPORTED AN ASPIRATION..

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18186651 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INITIAL KNEE REPLACEMENT APPROX 8 YEARS AGO. TRIATHLON TRITANIUM. SHE CAME TO SEE DR. SHARPE IN CLINIC WITH KNEE PAIN. X RAYS WERE TAKEN AND REVEALED THAT THE TIBIAL BASEPLATE WAS BROKEN AS WELL AS THE LATERAL POSTERIOR PROXIMAL FEMUR. REVISION SURGERY WAS (B)(6). ONCE THE KNEE WAS OPENED, WE NOTICED THE LOCKING WIRE ON POLY WAS BROKEN AS WELL. METAL WAS FLOATING AROUND THE JOINT AND ENDED UP UNDERNEATH THE POLY WHERE IT WAS WORK INTO THE BACKSIDE OF THE PLASTIC. ALL IMPLANTS WERE REMOVED AND REVISED WITH TRIATHLON TS. RIGHT KNEE. PER MEDICAL REVIEW OF X-RAY IMAGE DATED (B)(6), 2016: "THERE IS A FRACTURE OF THE INFERIOR POLE OF THE PATELLA PRESENT" WHICH REPORTEDLY "FULLY HEALED" WITHOUT MEDICAL INTERVENTION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 18037142 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER MEDICAL RECORDS RECEIVED: "INFERIOR POLE PATELLAR FRACTURE ON THE LEFT KNEE" OBSERVED ON X-RAY DATED (B)(6) 2015. IN THE OP VISIT NOTES DATED (B)(6) 2016 IT STATES, "AS HER LEFT PATELLA INFEREIOR POLE AVULSION FRACTURE HAS NOT CAUSED ANY EXTENSOR LAG AND HER SYMPTOMS ARE MILD IN THE KNEE AT THIS TIME THERE IS NO NEED TO ADDRESS SURGICALLY. WE WILL CONTINUE TO MONITOR THIS AT HER REGULAR VISITS."

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 18035816 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  PATIENT REPORTED EXPERIENCING PAIN, CLICKING AND "KNOCKING" SINCE PRIMARY SURGERY.

  Patient problems: Bone Fracture(s); Pain; Swelling/ Edema

  MAUDE report 17368612 ↗
• InjuryAug 30, 2022Adverse 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. AS REPORTED BY REP: "PATIENT WAS REVISED DUE TO SCAR TISSUE. PATELLA AND POLY WERE REMOVED. FEMUR AND TIBIA ALL COMPONENTS REMAINED." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Scar Tissue

  MAUDE report 15321297 ↗
• InjuryFeb 20, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER THE PATIENT HAD THEIR RIGHT KNEE REPLACED (PRIMARY PROCEDURE), PATIENT EXPERIENCED PAIN AFTER PHYSICAL THERAPY ON (B)(6) 2018 WHICH PERSISTED. THE SURGEON DECIDED TO REVISE THE PATIENT. THE PATELLAR COMPONENT WAS FOUND TO HAVE BEEN DETACHED FROM THE PATIENT'S NATIVE PATELLA WITH FIBROUS TISSUE ON BOTH THE BONE AND IMPLANT. SURGEON IS REPORTED TO BE EXPERIENCED WITH KNEE REPLACEMENTS AND ALWAYS CHECKS DRILL BIT SIZES BEFORE IMPLANTING PATELLAR COMPONENTS. AN A35 UNCEMENTED PATELLA WAS REVISED TO AN A35 CEMENTED PATELLA. THE DEVICE MAY BE AVAILABLE FOR RETURN AND THE

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8356591 ↗
• InjuryOct 31, 2018Break; Fracture; Break; Fracture

  SALES REP REPORTED, "PATIENT FELL AND LANDED IN A KNEELING POSITION. LEFT PATELLA BROKE. FRACTURED PATELLA REPAIRED AND TRITANIUM ASYMMETRIC PATELLA REVISED TO A POLY ASYMMETRIC PATELLA."

  Patient problems: Fall; Injury

  MAUDE report 8023753 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MY HUSBAND HAD A KNEE REPLACEMENT DONE IN (B)(6) OF 2017 AND FOR SEVERAL MONTHS HAD SWELLING, INSTABILITY AND SEVERE PAIN. THEN HE ENDED UP HAVING A REVISION DONE ON (B)(4) 2018. WHICH THERE IS STILL A LOT OF PAIN AND SWELLING.

  Patient problems: Fibrosis; Injury; Loss of Range of Motion; Pain; Swelling

  MAUDE report 7808996 ↗