Triathlon 5532-G-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327050844), received between Feb 17, 2017 and May 20, 2024 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Adverse 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 6X9 PS INSERT WAS SWAPPED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19349764 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A WASHOUT WAS PERFORMED AND A 6X9 PS INSERT WAS EXCHANGED FOR A NEW 6X9 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18949043 ↗
• InjuryMar 8, 2023Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF CLUNKING AND INSTABILITY. INTRA-OPERATIVELY, THE POST OF THE PS INSERT WAS OBSERVED TO BE SHEARED OFF (NO POSSIBLE CAUSE OR CONTRIBUTOR REPORTED TO REP). THE INSERT WAS REVISED. SURGEON IS REQUESTING INVESTIGATION RESULTS. REP CAN PROVIDE PICTURES AND POSSIBLY ADDITIONAL DOCUMENTATION, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16504412 ↗
• InjuryJan 25, 2023Fracture; Fracture

  THERE WAS A FRACTURE OF THE TIBIAL TRAY, DAMAGE TO THE POLYETHYLENE INSERT (SOME TIME AFTER THE ORIGINAL OPERATION) AND RELEASE OF THE ELEMENTS INTO THE JOINT. REVISION SURGERY ON (B)(6) 2023 WAS SUCCESSFULLY COMPLETED. THE INSERT WAS REPLACED WITH A NEW PS AND THE TIBIAL TRAY WAS REPLACED WITH A REVISION TS NO. 7 ALONG WITH 10 MM WASHERS, 100/ 21 MM PIN AND 6 MM OFFSET. PREVIOUSLY, THE PATIENT HAD ALSO UNDERGONE BARIATRIC SURGERY DUE TO HIGH BODY WEIGHT. UPDATE - THE PATIENT PRESENTED TO THE HOSPITAL AT THE BEGINNING OF (B)(6)2022 WITH DISCOMFORT OF THE KNEE JOINT , PREVIOUSLY HE HAD PRIMARY KNEE SURGERY ON THE TRIATHLON PRIMARY SYSTEM , SOME TIME LATER A KNEE LAVAGE ( DERO ) AND PE INSERT REPLACEMENT WAS PERFORMED DUE TO SYMPTOMS OF INFECTION . PREVIOUSLY, THE PATIENT HAD ALSO UNDERGONE BARIATRIC SURGERY DUE TO HIGH BODY WEIGHT . AFTER THE PATIENT REPORTED IN (B)(6)2022 AND WAS REFERRED FOR KNEE REVISION SURGERY.

  Patient problems: Discomfort

  MAUDE report 16240079 ↗
• InjuryDec 19, 2022Unstable; Unstable

  IT WAS REPORTED BY THE PATIENT, THAT HE WAS IMPLANTED WITH A RIGHT STRYKER KNEE ON (B)(6) 2019, AND REVISED ON (B)(6) 2021, DUE TO INSTABILITY. PER INDICATION IN OP REPORT, ¿PATIENT DEVELOPED INSTABILITY OF THE KNEE AND PRESUMED SYNOVITIS ASSOCIATED WITH THAT¿BROUGHT TO THE HOSPITAL FOR ARTHROTOMY, EXPLORATION, TIBIAL INSERT POLY EXCHANGE¿

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 16011465 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A HISTORY OF NATIVE LEFT KNEE SEPTIC ARTHRITIS. THE PATIENT UNDERWENT A PRIMARY LEFT TKA ON (B)(6) 2015. THE PATIENT DEVELOPED AN INFECTION OF THE LEFT KNEE AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 15307917 ↗
• InjuryAug 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POST OF THE INSERT SHEARING OFF (SURGEON REPORTED THAT THE PATIENT WAS PRONE TO MULTIPLE FALLS). INTRA-OPERATIVELY, THE SURGEON NOTICED A HAIRLINE FRACTURE OF THE PATELLAR COMPONENT. WHILE ADDRESSING IT, THE PATELLAR COMPONENT BROKE IN HALF. A 6X9 PS INSERT WAS REVISED TO A 6X11 CS INSERT AND THE PATELLA WAS REVISED.

  Patient problems: Fall

  MAUDE report 15143479 ↗
• InjuryJan 10, 2022Fracture; Fracture

  INSERT WHICH WAS IMPLANTED ON (B)(6) 2019 FRACTURED.

  Patient problems: Insufficient Information

  MAUDE report 13202863 ↗
• InjuryApr 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY ON (B)(6) 2013. RIGHT KNEE X-RAYS DOCUMENTED ABNORMAL CALCIFICATION NEAR THE INFERIOR POLE OF THE PATELLA. WITH PERSISTENT COMPLAINTS IT WAS DECIDED TO REMOVE THIS CALCIFICATION AND THIS WAS PERFORMED ON (B)(6) 2015. ARTHROTOMY WAS PERFORMED WITH REMOVAL OF THE BONY OSSICLE AND PARTIAL LATERAL RELEASE OF THE PATELLA.

  Patient problems: Calcium Deposits/Calcification; Injury

  MAUDE report 9997914 ↗
• InjuryJan 1, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A LOOSE TIBIA AND POSSIBLE POLY LYSIS. THE PATIENT'S TIBIAL BASEPLATE AND INSERT WERE REVISED. THE POLY IS ALLEGEDLY AVAILABLE FOR RETURN AS THE SURGEON WOULD LIKE ANALYSIS RESULTS OF IT. THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Osteolysis

  MAUDE report 9537186 ↗
• InjuryDec 17, 2019Malposition of Device; Malposition of Device

  PATIENT UNDERWENT A LEFT TKA ON (B)(6) 2019 PERFORMED BY DR. THE 2 WEEK POST OPERATIVE XRAY REVEALED THAT THE POSTERIOR STABILIZED INSERT APPEARED TO BE SUBLUXED ANTERIORLY. DR ELECTED TO REMOVE THE INSERT AND INSERTED A NEW POSTERIOR STABILIZED PS INSERT ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9480871 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE: LEFT TOTAL KNEE REVISION REMOVAL OF COMPONENTS, PLACEMENT OF ANTIBIOTIC SPACER. PRE-OP DIAGNOSIS: COMPLICATION ARTIFICIAL JOINT, FAILED LEFT TOTAL KNEE. NO FURTHER INFORMATION AVAILABLE". ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER PLACED. SPOKE TO REP. PATIENT WAS REVISED DUE TO INFECTION (UNKNOWN IF CLINICALLY CONFIRMED, UNKNOWN INFECTING MICROORGANISM).

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9070610 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION (INFECTION WAS REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED, UNKNOWN IF INFECTING MICROORGANISM IDENTIFIED). A #6 TIBIAL COMPONENT, 6X9 PS INSERT, A #5 PS FEMORAL COMPONENT AND AN A38X11 ASYMMETRIC PATELLA WERE REMOVED AND A SPACER PLACED. REP PROVIDED EXPLANT PICTURES AND THE PRIMARY USAGE SHEET, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8946454 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GLOBAL INSTABILITY OF RIGHT KNEE FOLLOWING TOTAL KNEE ARTHROPLASTY OF RIGHT KNEE WITH CHRONIC EFFUSIONS".

  Patient problems: Injury

  MAUDE report 8717115 ↗
• InjuryJun 11, 2019Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury; Joint Laxity

  MAUDE report 8686617 ↗
• InjuryMay 30, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  AS REPORTED: "PATIENT FELT LOOSE WITH 9MM INSERT. SURGEON REMOVED INSERT AND IMPLANTED 6X13 PS. PATIENT WAS STABLE. NO COMPLICATIONS. INFORMATION SUBMITTED WAS EVERYTHING FROM BOTH SURGEON AND HOSPITAL. NO FURTHER DETAILS".

  Patient problems: Injury

  MAUDE report 8654060 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. A 6X9 PS POLY WAS SWAPPED. REP PROVIDED PRE-REVISION X-RAYS AND IMPLANT SHEETS FOR PRIMARY AND REVISION, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8598971 ↗
• InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF RIGHT KNEE DUE TO POSSIBLE INFECTION. SALES REP PROVIDED X-RAYS, PRIMARY AND REVISION IMPLANT SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8522734 ↗
• InjuryApr 10, 2019Noise, Audible; Noise, Audible

  PATIENT CALLED STATING HE HAD A RIGHT KNEE REPLACEMENT DONE ON (B)(6) 2017. PATIENT REPORTED HE HAS A CLICKING NOISE EVERY TIME HE WALKS. UPDATE 29-MAR-2019: AS PER MEDICAL RECORDS, THE CORRECT PRIMARY IMPLANT DATE IS (B)(6) 2017. PATIENT WAS REVISED ON (B)(6) 2018 DUE TO CLICKING NOISE. THE POLY INSERT WAS REVISED.

  Patient problems: Injury

  MAUDE report 8499445 ↗
• MalfunctionMar 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  WHEN THE DOCTOR IS GOING TO IMPLANT TIBIAL INSERT, THE WIRE OF THE INSERT WAS DETACHED FROM THE INSERT. THE DOCTOR HAD TO USE ANOTHER INSERT TO FINISHED THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412074 ↗
• MalfunctionMar 4, 2019Difficult to Insert; Difficult to Insert

  WHEN THE PRODUCT WAS DRIVEN INTO THE # 6 TIBIA COMPONENT AS USUAL, THE INSERT WIRE IN THE # 6 TIBIA COMPONENT INSIDE CAME OUT AHEAD ABOUT 1 TO 2 CM IN THE ANTERIOR DIRECTION. THE BACK OF THE INSERT AND THE OUTSIDE OF THE INSERT WERE LOCKED AND IT WAS DIFFICULT TO REMOVE THE INSERT. SO CUT OFF THE INSERT WIRE WHICH PULLED OUT WITH THE PIN CUTTER OF THE HOSPITAL, PUT THE SAME INSERT AGAIN, AND CONTINUED TREATMENT AS IT WAS TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8386191 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT KNEE REPLACEMENT (B)(6) 2018. PATIENT HAD CHRONIC INFECTED RIGHT KNEE PROSTHESIS AND UNDERWENT RIGHT TOTAL KNEE REVISION OF ALL COMPONENTS ON (B)(6) 2018 WITH OFF-LABEL COMBINED PRODUCTS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8361901 ↗
• InjuryFeb 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A BROKEN POST OF THE INSERT. A 6X9 PS INSERT WAS REVISED TO A 6X13 PS INSERT. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury

  MAUDE report 8302298 ↗
• MalfunctionDec 19, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  SURGEON WENT TO IMPACT THE POLY AND THE LOCKING WIRE BENT DURING IMPACTION. POLY WAS REMOVED EASILY AND A SECOND ONE OF THE SAME SIZE WAS USED INSTEAD WITH NO REPORTED ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183181 ↗
• InjuryAug 21, 2018Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  PATIENT'S HUSBAND CALLED STATING HIS WIFE HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. A FEW MONTHS AFTER SHE STARTED EXPERIENCING PAIN AND SWELLING. PATIENT WAS REVISED TO COMPETITIVE DEVICES ON (B)(6) 2018. PATIENT IS SEEKING COMPENSATION.

  Patient problems: Inadequate Osseointegration; Injury; Pain; Swelling

  MAUDE report 7801019 ↗