Triathlon 5531-G-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327045581), received between Aug 2, 2018 and Oct 26, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2023Unstable; Unstable

  PATIENT REPORTED KNEE "COLLAPSES" AND WOULD LIKE TO KNOW IF PARTS ARE SUBJECT TO A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 18009584 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: DR. REVISED A TRIATHLON POLY DUE TO THE NEED FOR SOFT TISSUE RELEASING. NO ALLEGATIONS TOWARDS THE IMPLANT MADE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12775736 ↗
• InjuryApr 30, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. A 1 X 9 POLY INSERT WAS SWAPPED FOR A 1 X 11 POLY INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11752062 ↗
• MalfunctionMay 1, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WHEN INSERTING THE # 1 9MM INSERT, THE WIRE HOOKED IN FRONT OF THE BASE PLATE AND FLOATED SLIGHTLY. AN ATTEMPT WAS MADE TO INSERT THE WIRE, BUT THE WIRE CAME OFF AND COULD NOT BE USED. THERE WERE TWO TKA ON THE DAY, SO WE RESPONDED QUICKLY USING THE OTHER PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10017027 ↗
• InjuryNov 22, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  AS REPORTED: "SIZE 1 POLY IMPLANTED ON SIZE 2 UNIVERSAL BASEPLATE. PLANNED SIZE 1, CUT TO PLAN. DR CHANGED TIBIA TO A 2 DUE TO BONE QUALITY (REP CONFIRMED ADDITIONAL CUTTING WAS NOT REQUIRED). IMPLANTS WERE PLACED ON A SMALL PREP TABLE BY REP, AND NURSE CIRCULATOR HELD IMPLANTS UP FOR DR TO READ LABELS. DR. STOPPED OPERATING, TURNED AROUND AND SLOWLY READ EACH AND EVERY ITEM ON LABEL OF EACH IMPLANT, AND CONFIRMED THAT IS CORRECT, NURSE RE-READ SIZE AND EXPIRATION TO SCRUB PERSON, THEN OPENED IMPLANTS." SPOKE TO REP. PATIENT HAS DEVELOPED A SIGNIFICANT HEMATOMA AND REVISION SURGERY IS PLANNED TO OCCUR ON OR BY (B)(6) 2019. UPDATE: MPS WAS IN CHARGE OF RUNNING THIS MAKO TKA CASE. ON (B)(6) 2019, JR REP NOTICED THE DISCREPANCY DURING RESTOCKING. THE SALES SHEET WAS REVIEWED AND IT WAS CONFIRMED THAT A SIZE 1 FEMUR, SIZE 2 TIBIA AND SIZE 1 TIBIA POLYETHYLENE INSERT WERE IMPLANTED. SPOKE TO MPS. THERE ARE NO ALLEGATIONS AGAINST THE ROBOT OR ANY OF THE CUTS MADE IN THE PRIMARY PROCEDURE. CAUSE/ CONTRIBUTOR FOR THE HEMATOMA NOT REPORTED. UPDATE 27/NOVEMBER/2019 WG: ON (B)(6) 2019, REP WAS ABLE TO CONFIRM THAT THE PATIENT WAS REVISED ON (B)(6) 2019, REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 9364499 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2013. PATIENT HAD A HISTORY OF BILATERAL KNEE PAIN AND WENT TO ER WITH COMPLAINTS OF SEVERE DISABLING PAIN. PATIENT UNDERWENT BOTH KNEE INCISION AND DRAINAGE WITH WASHOUT, REVISION OF LINER COMPONENT (B)(6) 2018.

  Patient problems: Injury; Pain

  MAUDE report 8568639 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED STATING SHE HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. SHE STARTED EXPERIENCING PAIN THAT TRAVELS DOWN HER LEG TO HER ANKLE, BRUISE SENSATION WITHOUT A VISIBLE BRUISE INSIDE OF KNEE. PATIENT STATED SHE HAS SEEN DIFFERENT DOCTORS AND HAD PT BUT NOTHING HAS HELPED. PAIN KEEPS GETTING WORSE AND SHE CAN'T WALK VERY FAR.

  Patient problems: Burning Sensation; Pain

  MAUDE report 7743263 ↗