Triathlon 5551-G-350-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327314793), received between Nov 16, 2021 and Dec 5, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (K172634); they may or may not involve this specific model.

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.

• InjuryDec 5, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23733470 ↗
• InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE PATELLAR COMPONENT. THE PATELLAR COMPONENT AND INSERT WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23299975 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED THAT PATIENT HAD A FALL APPROXIMATELY 6 MONTHS AFTER THEIR INITIAL PROCEDURE. DID NOT ATTEND FOLLOW UP WITH GP OR SURGEON WHO COMPLETED INITIAL PROCEDURE. CONSULTED SURGEON IN 2025, WHO DETECTED A PATELLA COMPONENT ON IMAGING THAT APPEARED TO BE SEPARATED FROM BONE.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 22675247 ↗
• InjuryMar 31, 2025Unstable; Unstable

  REVISION OF RIGHT DISTAL FEMUR GMRS. ORIGINAL OP DATE ON (B)(6) 2025 (24HRS EARLIER). REVISION DUE TO PATELLA INSTABILITY. HELICOIDAL RASP USED TO BURR HOLE IN ¿THREADED¿ SIDE OF AXLE SO THAT FIBER TAPE COULD BE CEMENTED INTO IT AND USED TO STABILISE THE PATELLA. SURGEON ACKNOWLEDGED THAT THIS IS OFF LABEL. REVISION COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION PROVIDED ON 6/3/25: REASON FOR REVISION: PATELLA INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 21729659 ↗
• InjuryOct 29, 2024Loss of Osseointegration; Loss of Osseointegration

  A TRIATHLON TS KNEE WITH STEMS AND AUGMENTS WAS IMPLANTED ON (B)(6) 2020. AS OF 22/OCTOBER/2021, THE FOLLOWING WERE NOTED: "PATIENT FELL IN (B)(6) (2021) AND SUBSEQUENTLY INJURED HER KNEE AND WILL NEED HER PATELLAR REVISED IN THE FUTURE." IN (B)(6) 2021, PATELLAR LOOSENING WAS CITED. ON (B)(6) 2021, LOOSENING OF THE TIBIA WAS ALSO NOTED. AS OF (B)(6) 2021, THE PATIENT HAS NOT BEEN REVISED DUE TO PATIENT FACTORS.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 20559755 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT A CEMENTED PATELLAR COMPONENT WAS IMPLANTED WITHOUT CEMENT (IT WAS BELIEVED TO BE A PRESS-FIT PATELLA. THERE ARE NO ALLEGATIONS AGAINST THE DEVICE OR ITS LABELLING). DISCOVERY WAS MADE WHILE THE PATIENT WAS IN THE RECOVERY ROOM. THE PATIENT WAS BROUGHT BACK TO THE O.R., CEMENT WAS PREPARED, AND THE SAME IMPLANT THAT WAS ORIGINALLY IMPLANTED WAS THEN CEMENTED INTO THE PATIENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803525 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN DUE TO PAIN IN RIGHT KNEE. STARTED SUPEROLATERALLY AND INFEROLATERALLY AROUND THE PATELLA. ALSO INTERMITTENT SWELLING. ASPIRATED SHOWING WCC 14900. NO ORGANISMS. POSSIBLY VIRAL VS NON-SPECIFIC INFLAMMATION IN AETIOLOGY. NO IMPLANTS WERE REMOVED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14920884 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, HE HAD A RIGHT TKA DONE ON (B)(6) 2020. PATIENT HAS BEEN EXPERIENCING PAIN SINCE HIS SURGERY. HE HAS PROBLEMS URINATING, UNABLE TO LAY DOWN AND HAS TO SLEEP ON A RECLINER AND HE'S EXPERIENCING POPPING. HIS PAIN HAS NEVER STOPPED.

  Patient problems: Pain; Urinary Retention

  MAUDE report 14266006 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISED TODAY WAS A PATELLOFEMORAL. PRIMARY AND CONVERSION IMPLANT SHEETS AS WELL AS PICTURES ARE PROVIDED HERE. REVISED DUE TO IMPROPER PATELLA TRACKING." SPOKE TO REP: REP CONFIRMED THERE ARE NO ALLEGATIONS AS TO INACCURATE CUTS MADE IN THE ORIGINAL MAKO PROCEDURE. REP ALSO CONFIRMED THAT THE REVISION WAS COMPLETED ROBOTICALLY, AND THAT NO FURTHER INFO WILL BE RELEASED.

  Patient problems: Insufficient Information

  MAUDE report 12824055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E