Triathlon 5532-G-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327050707), received between Jan 5, 2017 and Jul 11, 2025 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22477321 ↗
• InjuryJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22458831 ↗
• InjuryJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22458503 ↗
• InjurySep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POST OF THE INSERT SHEARING OFF. THE INSERT WAS REVISED. REP REPORTED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20224346 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE ISSUE IS ABOUT A RIGHT KNEE PROSTHESIS INFECTION. ( IMPLANTATION DATE : (B)(6) 2023).

  Patient problems: Unspecified Infection

  MAUDE report 19110064 ↗
• InjuryFeb 28, 2024Unstable; Unstable

  PATIENT HAD A LEFT TKA ON (B)(6) 2017. PATIENT HAD A FALL AND STARTING HAVING SYMPTOMS OF INSTABILITY. PATIENT HAD A REVISION LEFT TKA ON (B)(6) 2023 WITH POLY EXCHANGE ONLY AND MCL REPAIR.

  Patient problems: Joint Laxity

  MAUDE report 18795439 ↗
• InjuryMar 8, 2023Adverse 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 DUE TO INFECTION. A 4X9 PS INSERT WAS REVISED TO A 4X13 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 16504136 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT REVISED DUE TO POSSIBLE INFECTION." A 4X9 PS INSERT WAS SWAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 14135108 ↗
• InjuryMar 13, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PATIENT COMPLAINT OF DISCOMFORT AND MEDIAL LAXITY. A 4X9 PS INSERT WAS REVISED TO A 4X15 PS INSERT.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13752570 ↗
• InjuryMay 19, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 PS INSERT WAS REVISED TO A 4X13 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11847404 ↗
• InjuryJan 7, 2021Adverse 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 DUE TO POSSIBLE INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH AN EXCHANGE OF A 4X9 PS INSERT FOR ANOTHER 4X9 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11131884 ↗
• InjuryNov 15, 2020Adverse 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 THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL FAILED LEFT TOTAL KNEE ARTHROPLASTY. UPDATE FROM MED REVIEW: (B)(6) 2017 OP REPORT: "REVISION LEFT TKA - FEMORAL AND TIBIAL COMPONENTS' FOR "PAINFUL, FAILED LEFT TKA WITH INADEQUATE FIXATION OF TIBIAL COMPONENT." " ...TIBIAL AND FEMORAL COMPONENTS REMOVED WITH OSTEOTOME - REVISED TO CEMENTED, MODULAR REVISION COMPONENTS. UNCOMPLICATED SURGERY - PATELLA NOT MENTIONED."

  Patient problems: Pain

  MAUDE report 10841560 ↗
• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED, "PATIENT PRESENTED WITH LIMITED RANGE OF MOTION DUE TO THE FORMATION OF FIBROTIC TISSUE, AFOREMENTIONED TISSUE WAS REMOVED, THE JOINT WASHED OUT PER SURGEON¿S I&D PROTOCOL(S), AND X3 INSERT WAS SWAPPED OUT. NO COMPLAINTS FILED AGAINST THE IMPLANTS, NO FURTHER INFO MADE AVAILABLE." SALES REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Insufficient Information

  MAUDE report 10604840 ↗
• MalfunctionSep 28, 2020Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: DURING A PTG TRIATHLON PROCEDURE, THE SURGEON WAS UNABLE TO PLACE THE IMPLANT BECAUSE THE METAL RING BECAME DETACHED DURING INSERTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10592499 ↗
• InjuryAug 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10458125 ↗
• InjuryFeb 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PS KNEE CONSTRUCT WAS REVISED TO A TS KNEE CONSTRUCT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9728343 ↗
• MalfunctionFeb 14, 2020Unstable; Positioning Problem; Unstable; Positioning Problem

  DURING MEDICAL PROCEDURE, THE SURGEON FOUND THAT TIBIAL INSERT WAS VERY HARD TO IMPLANT. AFTER BEAT SEVERAL TIMES, THE SURGEON FELT TIBIAL INSERT WAS INSTABILITY. AND THEN, THE SURGEON TOOK THE TIBIAL INSERT OUT TO IMPLANT AGAIN. BUT, THE WIRE WAS OUT OF INSERT AND COULD NOT BE USED AGAIN. FINALLY, THE OTHER REPLACEMENT WAS USED TO FINISH PROCEDURE. THE SURGERY WAS DELAY NEARLY 1 HOUR.

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

  MAUDE report 9711542 ↗
• InjuryDec 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "LEFT TOTAL KNEE REVISION, REMOVAL OF COMPONENTS, PLACEMENT OF ANTIBIOTIC SPACER. PRE-OP DIAGNOSIS: COMPLICATION ARTIFICIAL JOINT, FAILED TOTAL KNEE ARTHROPLASTY. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." SPOKE TO REP. INFECTION WAS VERBALLY REPORTED BY HOSPITAL STAFF.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9437860 ↗
• InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO TRAUMATIC ARTHROTOMY AND WOUND DEHISCENCE. THE PATIENT REPORTED THAT SHE FELL WHEN RUNNING FROM HER COUCH. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND A 4X9 PS INSERT WAS SWAPPED. INFECTION WAS NOT CONFIRMED AS NO CULTURES WERE TAKEN. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Wound Dehiscence

  MAUDE report 9274452 ↗
• InjurySep 4, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL LEFT TOTAL KNEE WITH OSTEOLYSIS OF THE TIBIAL COMPONENT, POLYETHYLENE WEAR.

  Patient problems: Injury; Osteolysis; Pain

  MAUDE report 8960146 ↗
• InjuryApr 11, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY (CHRONIC PROGRESSIVE INSTABILITY)".

  Patient problems: Injury

  MAUDE report 8504088 ↗
• InjuryJan 14, 2019Unstable; Unstable

  TIBIAL INSERT REVISION FOR INSTABILITY.

  Patient problems: Injury

  MAUDE report 8245412 ↗
• InjuryDec 17, 2018Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 INSERT WAS REVISED TO A 4X11 INSERT. REP REPORTED THAT NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8169205 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE REP 13 DAYS POST-OP BY SURGEON THAT A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S LEFT KNEE DUE TO INFECTION (INFECTION CONFIRMED BY PATHOLOGY BUT INFECTING MICROORGANISM NOT IDENTIFIED). ALL IMPLANTS WERE REMOVED AND A SPACER WAS IMPLANTED. NO STRYKER PERSONNEL WERE PRESENT FOR THE PROCEDURE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7947949 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION OF PRIMARY IMPLANTS IN PATIENT'S LEFT KNEE ON (B)(6) 2017. WHILE REPORTING A REVISION OF PATIENT'S LEFT KNEE WHICH TOOK PLACE ON (B)(6) 2018, REP DISCOVERED THE PATIENT HAD A REVISION ON (B)(6) 2017 WITH A WASHOUT AND POLY EXCHANGE DUE TO INFECTION. NEITHER THE REP NOR ANYONE ON HIS TEAM WAS PRESENT FOR THE PROCEDURE. A SIZE 5 CS INSERT WAS TAKEN OUT OF CONSIGNMENT TO REPLACE A SIZE 4 PS INSERT ON A SIZE 4 BASEPLATE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7884917 ↗