Triathlon 5532-G-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327050653), received between Jul 11, 2018 and Dec 14, 2022 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  REVISION: PATIENT LEFT KNEE UNSTABLE, PS INSERT BROKEN.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 15974955 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE RESURFACING THE PATIENT'S NATIVE PATELLA, THE SURGEON DECIDED TO REVISE A 3X13 PS INSERT TO A 3X14 PS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 15280286 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "ACHES AT NIGHT, PAINFUL WHEN DOING MANY CHORES, CONTINUING SWELLING. GARDENING, HOUSEKEEPING A BIT DIFFICULT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14161027 ↗
• InjuryMar 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE POST OF THE INSERT BREAKING OFF. A 3X13 PS INSERT WAS REVISED TO A 3X16 PS INSERT. THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN, AND THE REP CONFIRMED NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9866439 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE: IRRIGATION AND DEBRIDEMENT OF LEFT KNEE WOUND AND EXCHANGE OF TIBIAL LINER. PRE-OP DIAGNOSIS: INFECTED LEFT TOTAL KNEE ARTHROPLASTY WITH WOUND DISRUPTION. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." A 3X13 PS INSERT WAS REVISED TO A 3X14 PS INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9811383 ↗
• MalfunctionDec 26, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WHEN TRIATHLON PS X3 TIBIAL INSERT (13MM) WAS ATTEMPTED TO FIX USING AN IMPACTOR, INSIDE WAS FIXED WITHOUT A GAP. BUT THERE WAS ABOUT 1MM GAP OUTSIDE AND IT COULD NOT BE FIXED. THE BASE PLATE WAS THEN CLEANED COMPLETELY AND ATTEMPTED TO FIX THE INSERT AGAIN. BUT THE STATUS WAS THE SAME. THE INSERT WAS THEN EXCHANGED WITH 11MM ONE. THE REPORTER¿S REQUEST: PLEASE INVESTIGATE AND CONFIRM IF THE INSERT (13MM) CAN BE ACTUALLY FIXED TO A TIBIAL BASE PLATE. ALTERNATE TRANSLATION DECEMBER 5, 2019: X3 INSERT PS13MM WAS USED. I INSERTED IT WITH AN IMPACTOR BUT THE INSIDE WAS FIXED WITHOUT A GAP. THE OUTSIDE FLOATED ABOUT 1MM AND COULD NOT BE FIXED. AFTER THOROUGHLY CLEANING THE BASEPLATE AND TRYING AGAIN, THE SAME PHENOMENON OCCURRED AND AN 11MM INSERT WAS INSERTED. IS THERE A DEFECT IN THE INSERT ITSELF? IF NOT, WHAT CAN BE THE REASON FOR THIS?

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9521852 ↗
• MalfunctionMay 23, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  DR. INSERTED A TRIATHLON PS TIBIAL INSERT AND NOTICED PART OF THE LOCKING WIRE STICKING UP ABOVE THE EDGE OF THE BASEPLATE. THE INSERT WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME SIZE WITHOUT FURTHER INCIDENT. UPDATE 30/APRIL/2019 WG: SURGICAL DELAY IS REPORTED AS "YES". UPDATE: "DELAY WAS LESS THAN A MINUTE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8637047 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT HAD LEFT KNEE REPLACEMENT INDEX OUTSIDE OF CORS SCOPE. THE PATIENT UNDERWENT KNEE REVISION TO TREAT THE PAIN AND DYSFUNCTION AND MECHANICAL PROBLEM. ONLY CHANGING THE POLY ON (B)(6) 2015 . THEN PATIENT HAD INFECTED PROSTHESIS LEFT KNEE AND ALL COMPONENTS EXCHANGED ON (B)(6) 2016. THIS PI IS FOR 2ND REVISION DUE TO INFECTED PROSTHESIS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8361452 ↗
• InjuryJan 8, 2019Unstable; Noise, Audible; Unstable; Noise, Audible

  AS REPORTED THROUGH MW5078695: "PATIENT REPORTS SHE WAS UNABLE TO GET UP FROM HER BED ONE MORNING DUE TO SEVERE PAIN IN HER KNEE. SHE REPORTS HEARING CLICKS WHILE WALKING AND HAS EXPERIENCED WEAKNESS, SWELLING AND BUCKLING. HER ORTHOPEDIC SURGEON SAW "SOMETHING STICKING OUT OF HER BONE" AND MENTIONED THAT "SOMETHING PULLS AWAY" WHEN SHE MOVES HER KNEE. PATIENT IS WORRIED HER IMPLANT MAY HAVE BEEN RECALLED. THE PATIENT IS WEARING A KNEE BRACE FOR SUPPORT AND CAN NO LONGER HEAR THE CLICKING NOISE; HOWEVER, HER OTHER SYMPTOMS PERSIST." UPDATED AS PER MEDICAL REVIEW. ON (B)(6) 2018 A NOTE STATES, ¿SEEN (B)(6) 2018 AND DIAGNOSED WITH UNSTABLE RIGHT TKR ¿ REPORTS ASCENDING AND DESCENDING STAIRS VIRTUALLY IMPOSSIBLE ¿ REPORTS CLICKING SOUND AND SENSATION WITH WEIGHT BEARING. PHYSICAL EXAMINATION: 0° TO 120° WITH JOG OF LAXITY IN FULL EXTENSION AND 90° ¿ AP DRAWER TEST NEGATIVE. PLAN: BLEDSOE BRACE, STRENGTHENING EXERCISES, RETURN IN TWO MONTHS.¿

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 8229119 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016. PATIENT HAD REVISION AND REIMPLANTATION DUE TO PJI ON (B)(6) 2018. ALL COMPONENTS WERE EXCHANGED".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7969079 ↗
• InjuryJul 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD KNEE PAIN AND INSTABILITY. SURGEON REMOVED PS TIBIAL INSERT AND REPLACED WITH THICKER INSERT. PATIENT STABLE."

  Patient problems: Injury; Pain

  MAUDE report 7678907 ↗