Triathlon 5532-G-209Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327046205), received between Jul 6, 2017 and May 9, 2022 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 9, 2022Unstable; Unstable

  PATIENT CALLED AND IS INQUIRING ABOUT RECALL FOR HER RIGHT KNEE SURGERY ON (B)(6) 2016. UPDATE (B)(6) 2022: PATIENT IS EXPERIENCING INSTABILITY. SHE HAS SEEN THREE DIFFERENT SURGEONS AND HAS UPCOMING REVISION SURGERY IN (B)(6). PATIENT WOULD LIKE TO KNOW WHAT IMPLANTS SHE CAN USE IN HER REVISION FOR A BETTER OUTCOME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14342924 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, SHE HAD BILATERAL TKA DONE ON (B)(6) 2011. THE PATIENT STATED SHE STARTED TO EXPERIENCE PAIN ON BOTH KNEES SINCE HER SURGERY. PATIENT STATED ITS HARD TO GET UP AND DOWN FROM A CHAIR. THE PATIENT STATED HER RIGHT KNEE IS WORSE THAN THE LEFT. PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2013. THE PATIENT STATED SHE IS STILL EXPERIENCING PAIN ON BOTH KNEES AND HER PAIN HASN'T GOTTEN BETTER. PATIENT IS NOT ABLE TO CLIMB STEPS WITHOUT ASSISTANCE. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE OF RECALL.

  Patient problems: Pain

  MAUDE report 14186345 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SYMPTOMS OF AN ACUTE-INFECTION AND DRAINING SURGICAL-WOUND. HER RIGHT KNEE WAS WASHED OUT AND THE X3 INSERT SWAPPED OUT AS PART OF DOCTOR I&D PROTOCOL. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS. THE EXPLANTED-ITEM IS NOT AVAILABLE FOR RETURN. NO FURTHER INFO. HAS BEEN MADE AVAILABLE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12163740 ↗
• MalfunctionAug 11, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE 9MM INSERT WAS USED AND THE FINAL DRIVE WAS CARRIED OUT, BUT THE REAR PART DID NOT FIT FIRMLY AND IT WAS UNABLE TO FIT EVEN WITH MANY TIMES OF ATTEMPT. THE SURGEON COULDN'T USE THE IMPLANT WITH THE CORRECT THICKNESS, BUT ENDED UP WITH A SLIGHTLY THICK IMPLANT. THE SHAPE BEHIND THE IMPLANT SEEMED TO BE SLIGHTLY DEFORMED, AND THIS KIND OF DEFORMATION DOES NOT OCCUR BY HITTING THE IMPLANT. SO, PLEASE INVESTIGATE IF SHAPE OF PRODUCT WAS DEFECTIVE OR NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10390476 ↗
• InjuryDec 12, 2019Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  AS REPORTED: "POLY EXCHANGE TODAY. RIGHT KNEE. ORIGINAL AND TODAY'S [USAGE] SHEETS ATTACHED. PATIENT COMPLAINED OF RANGE OF MOTION ISSUES. SURGEON MENTIONED CALCIFICATION IN JOINT, SCARRING ISSUES, ETC. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 9459226 ↗
• MalfunctionNov 21, 2019Mechanical Problem; Mechanical Problem

  PMH REPORTED THAT THE LOCKING WIRE WAS LOOSENED WHEN THEY IMPLANTED INTO THE BASEPLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353249 ↗
• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "FIRST STAGE WASH-OUT POLY SWAP RIGHT KNEE (INFECTION)".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8457257 ↗
• InjuryJan 15, 2019Unstable; Unstable

  AS REPORTED: "PATIENT...HAD A LEFT PRIMARY TOTAL KNEE DONE...ON (B)(6) 2017. OVER THE PAST YEAR PATIENT...ENDED UP [AT SURGEON AND HOSPITAL] WITH A CHIEF COMPLAINT OF PAIN AND INSTABILITY. [SURGEON] TOLD ME THERE WAS POSITIVE UPTAKE ON A BONE SCAN AS WELL AS MRI FOR TIBIAL BASEPLATE LOOSENING. THE PATIENT WENT INTO SURGERY ON (B)(6) 2018 AND HAD THE SIZE 2 TRITANIUM BASEPLATE AND SIZE 2X9MM POLY REPLACED WITH A CEMENTED UNIVERSAL BASEPLATE AND 12X50 STEM AND 2X16MM POLY."

  Patient problems: Injury; Pain

  MAUDE report 8250296 ↗
• MalfunctionFeb 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SALES STAFF REPORTED THAT DURING OPERATION THAT THE SURGEON USED INSERT IMPACTOR TO PUSH INSERT SIZE 9 INTO LOCKING MECHANISM OF TIBIA TRAY THEN IT COULD NOT LOCK. SURGEON DECIDED TO REMOVE INSERT AND INSERT WAS CHIPPED IN THE PROCESS. AND A NEW INSERT SIZE 11 WAS USED INTRAOPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267961 ↗
• MalfunctionDec 19, 2017Noise, Audible; Noise, Audible

  PATIENT REPORTED THAT HER TRIATHLON KNEE IMPLANT HAVE A CLUNKING SENSATION WHILE WALKING. PATIENT IS NINE WEEKS POST SURGERY. PATIENT STATED THAT HER KNEE FEELS GREAT, BUT SHE DOES NOTICE A CLUNKING SENSATION WHEN SHE WALKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129202 ↗
• InjuryOct 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS DOING FANTASTIC FOLLOWING SURGERY UNTIL LAST WEEK WHEN THEY DEVELOPED A SINUS INFECTION. PATIENT WENT TO ER FOR SINUS TREATMENT AND WAS PUT ON ANTIBIOTICS. A FEW DAYS LATER PATIENT DEVELOPED PAIN, STIFFNESS, SWELLING IN KNEE AND WAS WORKED UP FOR AN INFECTION. I&D WAS PERFORMED WITH POLY EXCHANGE.

  Patient problems: Injury; Pain; Swelling; Unspecified Infection

  MAUDE report 6983043 ↗
• MalfunctionJul 6, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TRIATHLON PS TIBIAL INSERT X3 HAS MALFUNCTION AND DETERIORATION CHARACTERISTICS. IT IS OBSERVED BY THE SURGEON THAT IMPLANT WAS NOT SEATED ON TIBIAL BASEPLATE DURING TKA AS THE POSTERIOR LATERAL EDGE OF INSERT WAS BULGED AND INTERIOR LATERAL FACE HAS GROOVE, THEN WAS REPLACED BY ANOTHER IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6691979 ↗