Triathlon 5532-G-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327046274), received between Sep 28, 2017 and Jul 17, 2025 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "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: Loss of Range of Motion

  MAUDE report 22538814 ↗
• 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: Loss of Range of Motion

  MAUDE report 22477614 ↗
• 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 22458758 ↗
• InjuryApr 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PATIENT DISLOCATING (FEMORAL COMPONENT RIDING OFF THE POSTERIOR OF THE INSERT). INTRA-OPERATIVELY, THE POST OF THE INSERT WAS FOUND TO HAVE BROKEN OFF OF THE INSERT. THE PATIENT WAS REVISED FROM A 7X9 PS INSERT TO A 7X12 PS INSERT. THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL COMPONENT, WHICH WAS NOT REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11668857 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) YEAR-OLD MALE WHO PRESENTS WITH LEFT KNEE PAIN. HE IS NOW 11 MONTHS STATUS POST LEFT TOTAL KNEE REPLACEMENT. HE HAD BEEN DOING EXTREMELY WELL UP UNTIL ABOUT A WEEK AGO. HE NOW PRESENTS WITH ACUTE WORSENING OF LEFT KNEE PAIN WITH SWELLING AND SUBJECTIVE FEVERS. THE TIMING OF THIS EVENT WAS FOLLOWING A DENTAL PROCEDURE AND ALSO DOING WORK AT HIS LAKE HOUSE. HE HAS NO OPEN WOUNDS OR RECENT INFECTIONS. X-RAYS LOOK GOOD WITH NO EVIDENCE OF LOOSENING OR MECHANICAL FAILURE. BLOOD WORK AND LEFT KNEE ASPIRATION RESULTS DEMONSTRATE LEFT KNEE INFECTION WITH STREPTOCOCCUS ANGINOSUS. I THINK THIS LIKELY REPRESENTS A LATE HEMATOGENOUS ACUTE INFECTION. I HAVE RECOMMENDED IRRIGATION AND DEBRIDEMENT OF THE LEFT KNEE WITH IMPLANT RETENTION AND POLYETHYLENE EXCHANGE.

  Patient problems: Bacterial Infection

  MAUDE report 11555545 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN PROVIDING RECORDS FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2019, AN OFFICE VISIT NOTE FROM (B)(6) 2019 INDICATES "A SIZEABLE EFFUSION OF THE LEFT KNEE." AN ASPIRATION "OF 80 CC OF BLOODY, THIN FLUID" WAS PERFORMED. STUDY SITE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11192929 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "CASE: RIGHT REVISION TKA, POLY LINER EXCHANGE. DIAGNOSIS: HISTORY OF TKA, RIGHT. CHRONIC PAIN OF RIGHT KNEE. NO FURTHER INFO AVAILABLE PER HOSPITAL." A 7X9 PS INSERT WAS EXCHANGED FOR A 7X11 PS INSERT.

  Patient problems: Injury; Pain

  MAUDE report 10189479 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED: "WASH OUT/POLY SWAP. INFECTED TOTAL RIGHT KNEE."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9822893 ↗
• InjuryFeb 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A 7X9 PS INSERT WAS SWAPPED FOR ANOTHER 7X9 PS INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9702460 ↗
• InjuryJun 28, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "THE PATIENT WAS GETTING OUT OF A CHAIR AND THE FEMUR JUMPED THE POLY POST ANTERIORLY. THE PATIENT TOOK A PHOTO OF THIS OCCURRENCE AND SHOWED IT TO THE SURGEON OR HE WOULDN'T HAVE BELIEVED THIS WAS POSSIBLE. SINCE THEN THE PATIENT HAS COMPLAINED OF A UNSTABLE KNEE ASSOCIATED WITH PAIN". SURGEON DECIDED TO IMPLANT A THICKER POLY WITH COMMENT "...AN INDUSTRY POTENTIAL CRITICISM OF THIS KNEE IS THAT THE POST DOES NOT INCREASE IN SIZE AS THE IMPLANT GETS LARGER".

  Patient problems: Injury; Pain

  MAUDE report 8743711 ↗
• InjuryJun 27, 2019Unstable; Unstable

  IN PROVIDING INFORMATION FOR A REVISION FOR A DIFFERENT PATIENT, REP SUPPLIED AN OPERATIVE REPORT THAT MADE REFERENCE TO SEEING THE SAME DEVICE BEHAVIOR IN A PREVIOUS PATIENT. REP WAS ABLE TO OBTAIN SOME PATIENT AND DEVICE INFORMATION FOR THIS ADDITIONAL CASE. AS REPORTED BY THE REP: "THE PATIENT WAS GETTING OUT OF A CHAIR AND THE FEMUR JUMPED THE POLY POST ANTERIORLY. SINCE THEN THE PATIENT HAS COMPLAINED OF A UNSTABLE KNEE ASSOCIATED WITH PAIN." PATIENT HAS SINCE BEEN REVISED TO A THICKER INSERT.

  Patient problems: Injury; Pain

  MAUDE report 8738875 ↗
• InjuryJun 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " RIGHT KNEE PAIN, HYPERTROPHIC SYNOVIUM, STATUS-POST TOTAL KNEE ARTHROPLASTY."

  Patient problems: Injury; Pain; Synovitis

  MAUDE report 8687087 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2018. PATIENT UNDERWENT A RIGHT REVISION TOTAL KNEE ARTHROPLASTY TO TREAT INFECTION (B)(6) 2018. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8361453 ↗
• InjuryFeb 18, 2019Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. INTRAOPERATIVELY, THE POST ON THE PS INSERT WAS NOTED TO BE BROKEN. A 7X9 PS INSERT WAS REVISED TO A 7X11 PS INSERT.

  Patient problems: Injury

  MAUDE report 8347939 ↗
• InjuryJan 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A PRIMARY TOTAL KNEE (B)(6) 2018. PATIENT SHOWED UP FOR FOLLOW UP WITH WOUND COMPLICATIONS. PATIENT WAS TAKEN TO THE OR FOR A SUSPECTED INFECTION. SURGEON NOTED THE WOUND WAS CLEAN BUT HAD SOME NECROTIC TISSUE. THE POLY WAS EXCHANGED AS A PRECAUTION. SURGEON ALSO NOTED THAT THE PATIENT WAS ON ANTI CANCER DRUGS THAT CONTRIBUTED TO THE WOUND BREAKDOWN. WOUND WAS COPIOUSLY IRRIGATED AND THE POLY EXCHANGED SUCCESSFULLY. UPDATE (B)(4) 2018: SPOKE TO REP. INFECTION WAS NOT CONFIRMED BY PATHOLOGY BUT SURGEON REPORTED THAT HE FELT THERE WAS NO INFECTION. REP PROVIDED PRIMARY AND REVISION IMPLANT SHEETS, AND REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Post Operative Wound Infection

  MAUDE report 8210226 ↗
• InjuryJul 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FIRST-STAGE REVISION WAS PERFORMED ON THE PATIENTS' LEFT KNEE WITH THE IMPLANTATION OF A "2-STAGE SPACER" AFTER ALL PRIMARY IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7691300 ↗
• MalfunctionMar 23, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  SURGEON ATTEMPTED TO IMPACT TIBIAL INSERT AS PER USUAL TECHNIQUE (USING CORRECT INSERT IMPACTOR). HOWEVER, INSERT WOULD NOT ENGAGE AS IT SHOULD AND WHEN THE SURGEON TOOK THE INSERT OUT FOR FURTHER INSPECTION, IT WAS NOTED THAT THE WIRE HAD COMPLETELY DETACHED FROM THE INSERT. THE INITIAL CR INSERT WAS REPLACED WITH A CS EQUIVALENT INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365291 ↗
• InjuryMar 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPANY REP REPORTED THAT PATIENT HAD A POLY SWAP DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7363661 ↗
• InjuryMar 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE ONE REVISION OF PATIENT'S LEFT KNEE WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7363655 ↗
• MalfunctionFeb 2, 2018Detachment Of Device Component; Scratched Material; Detachment Of Device Component; Scratched Material

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE WIRE SURROUNDING THE POLYETHYLENE IS LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7235446 ↗
• InjuryDec 11, 2017Migration or Expulsion of Device; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) (APPROXIMATELY 6 MONTHS POST TRIATHLON PS TOTAL KNEE REPLACEMENT) WITH A LOCKED KNEE POST REPORTED HYPERFLEXION (PATIENT CROUCHING TO TIE HIS CONTRALATERAL SHOE LACE). FINDINGS ON X-RAY REVEALED A MALPLACED FEMORAL COMPONENT OVER THE INSERT POST OF THE TIBIAL INSERT. THE PATIENT'S KNEE WAS RELOCATED UNDER ANAESTHETIC ON (B)(6).

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 7104468 ↗
• InjurySep 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "INCISION AND DRAINAGE OF LEFT TOTAL KNEE".

  Patient problems: Injury

  MAUDE report 6900833 ↗