Triathlon 5532-G-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327050646), received between Jun 13, 2017 and Jul 15, 2025 — classified as 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 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: Ambulation or Postural Difficulties

  MAUDE report 22508734 ↗
• InjuryJul 11, 2025Mechanical Problem; Mechanical Problem

  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 22483007 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  NO NEW INFORMATION.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 22420324 ↗
• InjuryApr 3, 2025Adverse 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 ROM ISSUES/ SOFT TISSUE ADHESIONS. A 3X9 PS INSERT WAS REVISED TO A 3X9 CS INSERT. SURGEON HAD INTENDED TO REVISE TO ANOTHER 3X9 PS INSERT. HOWEVER, AFTER TRYING TO IMPLANT THE PS INSERT, THERE WAS SOFT TISSUE IMPINGEMENT PREVENTING THE INSERT FROM LOCKING IN. THE INSERT WAS WASTED AND THE 3X9 CS INSERT, WHICH WAS AVAILABLE TO THE OR, WAS USED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 21766824 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "REV LTKA FOR INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 21560282 ↗
• InjuryFeb 25, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSERT WEAR. WEAR WAS NOTED POSTERIORLY AND MEDIALLY AND REPORTED AS AN ABNORMAL WEAR PATTERN. A 3X9 PS INSERT WAS REVISED TO A 3X9 CS INSERT. REP CAN PROVIDE PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 21464834 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "ACUTE INFECTION, RTK. I&D, RTK WITH POLYETHYLENE EXCHANGE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." A 3X9 PS INSERT WAS REVISED TO A 3X10 PS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 14795165 ↗
• MalfunctionSep 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE OPERATION, IT WAS FOUND THAT THE METAL WIRE UNDER THE TRIATHLON X3 INSERT WAS DAMAGED AND COULD NOT BE USED, THEN REPLACED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482815 ↗
• MalfunctionSep 28, 2020Fracture; Fracture

  AFTER THE IMPLANTS WERE INSERTED, THE SURGEON WANTED TO REPLACE THE INSERT DURING MAKO ROBOTIC KNEE SURGERY. THE IMPLANT WAS DAMAGED DURING REMOVAL AND BECAME UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10594179 ↗
• InjuryJul 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. THE IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE SALES REP REPORTED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND THE HOSPITAL RETAINED THE EXPLANTS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10294558 ↗
• InjuryJan 23, 2020Unstable; Unstable

  AS REPORTED: "PAIN AND INSTABILITY. ALL AVAILABLE INFORMATION SUBMITTED. ORIGINAL SURGERY DONE ELSEWHERE." THE PATIENT'S RIGHT KNEE WAS REVISED. A 3X9 PS X3 INSERT WAS REVISED TO ANOTHER 3X9 PS X3 INSERT.

  Patient problems: Injury; Pain

  MAUDE report 9624167 ↗
• InjuryDec 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW FOR ANOTHER PI, ON (B)(6) 2013 THE OFFICE NOTE STATES, "... RIGHT KNEE ... PAIN FREE ... APRIL STARTED HURTING ... BY JUNE VERY BAD ... NOTHING HELPED CONSIDERED REVISION ... PHYSICAL EXAMINATION ... RIGHT KNEE FULL EXTENSION AND FLEXION, NO EFFUSION,, NO ERYTHEMA, NO WARMTH, NO INSTABILITY ... GLOBAL TENDERNESS ... PLAN ... ARTHROSCOPIC EVALUATION WITH LYSIS OF ADHESIONS/SCAR DEBRIDEMENT ..." ON (B)(6) 2013 AN ARTHROSCOPIC EVALUATION WITH LYSIS OF ADHESION AND EXTENSIVE PARTIAL SYNOVECTOMY WAS PERFORMED FOR A PRE- AND POST- OPERATIVE DIAGNOSIS OF "RIGHT PAINFUL TOTAL KNEE REPLACEMENT/ ADHESIONS/SCAR". [...] THE OPERATIVE NOTES STATES. "... TWO PLICA-LIKE STRUCTURES REMOVED ... OTHER SCAR TISSUE REMOVED."

  Patient problems: Injury; Pain; Scar Tissue

  MAUDE report 9520430 ↗
• InjuryDec 16, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 3X9 PS INSERT WAS REVISED TO A 3X13 TS INSERT.

  Patient problems: Injury

  MAUDE report 9476423 ↗
• InjuryJun 24, 2019Insufficient 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 (INFECTION WAS CLINICALLY CONFIRMED. INFECTING MICROORGANISM NOT REPORTED TO REP). REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8727174 ↗
• InjuryMar 14, 2019Adverse 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 ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury; Insufficient Information

  MAUDE report 8420256 ↗
• MalfunctionJul 10, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SURGEON'S PREFERENCE IS TO HOLD THE POLY UNTIL THE CEMENT HAS HARDENED. ALL SURGICAL STAFF ARE IN STRYKER HOODS & HELMETS, AT ALL TIMES. THE TIBIAL INSERT WAS CONFIRMED BY THE SURGEON. INNER, STERILE, PACKAGE DELIVERED TO THE FIELD APPROPRIATELY BY THE CIRCULATING RN. INNER PACKAGE REMAINED INTACT UNTIL HE OPENED IT. SURGEON PROCLAIMED, "THERE IS A HAIR ON THE INSERT." I WAS THEN SHOWN THE INSERT. ON THE ANTERIOR ASPECT OF THE POLY, NEAR THE RETENTION WIRE WAS A HAIR. I RESPONDED WITH, "PLEASE, PASS THE INSERT OFF THE FIELD. I WILL GET ANOTHER." INSERT WAS PLACED IN A SPECIMEN CONTAINER. WHICH WAS SUBSEQUENTLY RETURNED TO THE ORIGINAL PACKAGING, ALONG WITH THE REMAINING STICKERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7675517 ↗
• InjuryJul 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ADVERSE EVENT OF ARTHROFIBROSIS WITH A START DATE OF (B)(6) 2016 WAS REPORTED AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2016 SUBJECT WAS PRESCRIBED PT, ON (B)(6) 2016 SUBJECT UNDERWENT MUA, THEN A CPM MACHINE. (B)(6) 2016 THE KNEE WAS ASPIRATED. ON (B)(6) 2016 SUBJECT HAD A SYNVISC INJECTION. THE SUBJECT RETURNED ON (B)(6) 2017 AND REPORTED KNEE SYMPTOMS TO BE INTOLERABLE WITH LOSS OF ROM. PI REPORTS RADIOGRAPHS TAKEN ON (B)(6) 2017 DEMONSTRATED WELL-FIXED, WELL-POSITIONED COMPONENTS WITH NO EVIDENCE OF LOOSENING OR MECHANICAL FAILURE. REVISION OF THE (R) TKA ON (B)(6) 2017 FOR ARTHROFIBROSIS. SUBJECT'S REVISION OCCURRED ON (B)(6) 2017 WITHOUT COMPLICATIONS AND SHE WAS DISCHARGED IN GOOD CONDITION TO HER HOME ON (B)(6) 2017.

  Patient problems: Fibrosis; Injury; Loss of Range of Motion

  MAUDE report 7659128 ↗
• InjuryApr 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT I AND D WITH LINER EXCHANGE FOLLOWING PRIMARY [LEFT] TKA [DUE TO PERIPROSTHETIC JOINT INFECTION].

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7421956 ↗
• InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. REP REPORTED REASON FOR REVISION: "WOUND DEHISCENCE, RESULTING IN INFECTION."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7396538 ↗
• MalfunctionJan 23, 2018Device Operates Differently Than Expected; Material Deformation; Scratched Material; Device Operates Differently Than Expected; Material Deformation; Scratched Material

  DURING OPERATION, TRIATHLON INSERT HAD A BONE FRAGMENTS IN THE LOCKING SO THAT IT COULD NOT BE PLACED RIGHT. SO, HCP HAD TO OFF THE INSERT TO CLEAR THE BONE, DURING REMOVING THE INSERT, THE LOCKING MECHANISM WAS DAMAGED AND SO HCP USED THE NEW INSERT FOR THE PATIENT INTRAOPERATIVELY.

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

  MAUDE report 7212745 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT UNDERWENT MANIPULATION UNDER ANAESTHESIA (MUA) OF THE LEFT KNEE DUE TO TIGHTNESS FOLLOWING TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury; Loss of Range of Motion; Scar Tissue

  MAUDE report 7162351 ↗
• InjurySep 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED A STIFF RIGHT KNEE. THE PHYSICIAN PERFORMED AN OPEN MANIPULATION AND REPLACED THE POLY.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 6900048 ↗
• InjuryJun 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. SHE SHOWED UP FOR FOLLOW UP 10 MONTHS POST OP WITH PAIN AND RADIOGRAPHIC CHANGES. SHE WAS WORKED UP FOR INFECTION. SHE WAS SCHEDULED FOR EXPLANTATION AND IMPLANTATION OF AN ANTIBIOTIC SPACER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6637416 ↗