Triathlon 5532-G-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327050639), received between Jan 3, 2018 and Jul 17, 2025 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 24 most recent of 24 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

  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 22538815 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF HEMATOMA FROM FALL WITH POLY SWAP.

  Patient problems: Fall; Hematoma

  MAUDE report 21948875 ↗
• InjuryJan 21, 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 LIMITED ROM. A 3X11 PS INSERT WAS REVISED TO A 3X9 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 21199542 ↗
• InjuryJan 5, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LIMITED ROM. A DEBRIDEMENT WAS PERFORMED AND A 3X11 INSERT WAS REVISED TO A 3X9 INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 18449681 ↗
• InjuryJan 25, 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 LACK OF ROM AND PAIN (SURGEON REPORTED THIS WAS DUE TO PATIENT COMORBIDITIES). INTRA-OPERATIVELY, NO IMPLANTS WERE OBSERVED LOOSE (OBSERVED AS WELL-FIXED) OR BROKEN. A TRIATHLON PS KNEE WAS CONVERTED TO A TRIATHLON TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16241040 ↗
• InjuryOct 16, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  PRIMARY TKA WAS PERFORMED IN 2018. REVISION WAS REQUIRED DUE TO LOOSENING. DURING PROCEDURE, IT WAS FOUND THAT THE POST OF THE INSERT WAS BROKEN. ACCORDING TO THE DOCTOR'S OPINION, THE POST WAS PROBABLY BROKEN DUE TO PRESSURE DUE TO PATIENT'S FALL.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 15612891 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SHE HAD A LEFT TKA ON (B)(6) 2020. PATIENT STARTED TO EXPERIENCE PAIN TWO MONTHS AFTER HER SURGERY. PATIENT HAD PHYSICAL THERAPY FOR 8 MONTHS. PATIENT STATED SHE'S IN EXCRUCIATING PAIN ALL DAY AND IS ALSO EXPERIENCING CLICKING ON HER KNEE. PATIENT WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART RECALL.

  Patient problems: Pain

  MAUDE report 13878491 ↗
• InjuryNov 2, 2021Adverse 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 FOR INFECTION. A WASHOUT AND POLY EXCHANGE WAS DONE. A 3X11 PS INSERT WAS SWAPPED FOR A 3X13 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12736835 ↗
• InjuryOct 22, 2021Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  PATIENT REPORTED SHE HAD A LEFT TKA ON (B)(6) 2018. PATIENT STATED THAT SINCE HER SURGERY SHE HAS EXPERIENCED SWELLING AND PAIN. PATIENT HAD X-RAYS DONE AND WAS TOLD BY HER SURGEON THAT HE KNEE WAS LOOSE AND SHE REQUIRES REVISION SURGERY. PATIENT WOULD TO KNOW IF HER IMPLANTS ARE PART OF A RECALL.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12681992 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT KNEE EXPLANTATION WITH PLACEMENT OF ANTIBIOTIC SPACER. PRE-OP DIAGNOSIS: PAIN DUE TO RTK REPLACEMENT, SUBSEQUENT ENCOUNTER KNEE EFFUSION, RIGHT. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." REP PROVIDED A PRIMARY USAGE SHEET AND X-RAYS.

  Patient problems: Pain

  MAUDE report 11816923 ↗
• InjuryMar 17, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO EXTREMELY LIMITED RANGE OF MOTION. A SIZE 3 BASEPLATE AND 3X11 PS INSERT WERE REVISED TO A SIZE 3 UNIVERSAL BASEPLATE WITH AUGMENTS AND STEM, AND A 3X16 TS INSERT. REP REPORTED THAT HE MAY BE ABLE TO GET THE DATE OF PRIMARY IMPLANTATION, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 11507375 ↗
• InjuryMar 12, 2021Unstable; Unstable

  REMOVAL OF PRIMARY TRIATHLON IMPLANTS DUE TO INSTABILITY AND REPLACEMENT WITH TRIATHLON TS.

  Patient problems: Joint Laxity

  MAUDE report 11474292 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IN PROVIDING MEDICAL RECORDS FOR REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2019, AN OFFICE NOT FROM (B)(6) 2019 WAS PROVIDED WITH COMPLAINT OF "LEFT KNEE SWELLING, PAIN, AND FEVER." THE PATIENT'S KNEE WAS ASPIRATED UNDER ANESTHESIA. SURGEON ALSO REPORTED "I DISCUSSED THAT THERE IS CONCERN FOR A SEPTIC JOINT..." STUDY SITE CONFIRMED THAT NO FURTHER INFORMATION WILL BE SUBMITTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 11176232 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  TRIATHLON TRITANIUM IMPLANTED AT INITIAL SURGERY. INFECTED TKA LED TO I&D AND POLY LINER EXCHANGE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 10964780 ↗
• InjuryJul 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION OF PRIMARY. PATIENT HAD A RIGHT TKA DONE ON (B)(6) 2015. PATIENT'S KNEE WOULD GO BACKWARDS WHEN SHE WOULD TRY TO STRAIGHTEN IT OUT AND ALMOST FELL A COUPLE OF TIMES. PATIENT WENT TO HER SURGEON AND WAS REVISED ON (B)(6) 2018. AFTER REVISION PATIENT WAS EXPERIENCING PAIN AND KNEE WAS FILLING UP WITH FLUID. PATIENT HAD PHYSICAL THERAPY AND WAS TOLD HER DEVICE WAS LOOSE. PATIENT WENT TO ANOTHER SURGEON AND WAS REVISED ON (B)(6) 2020 TO COMPETITOR IMPLANTS. PATIENT IS ONLY INQUIRING IF HER IMPLANTS ARE PART OF A RECALL.

  Patient problems: Injury

  MAUDE report 10294979 ↗
• InjuryMar 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION INSTABILITY. A PS FEMUR AND INSERT WERE REVISED TO A TS FEMUR WITH AUGMENTS AND A STEM, AND A TS INSERT. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9898004 ↗
• InjuryOct 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POOR ROM. A SYNOVECTOMY AND POLY SWAP WAS PERFORMED INCLUDING REMOVAL OF SCAR TISSUE. A 3X11 PS INSERT WAS REVISED TO A 3X9 PS INSERT. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE PATIENT'S IMPLANTS, CAN PROVIDE PRIMARY AND USAGE INFORMATION AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 9139482 ↗
• InjuryJul 25, 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 "FAILED LEFT TOTAL KNEE REPLACEMENT."

  Patient problems: Injury

  MAUDE report 8827734 ↗
• InjuryJul 2, 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 "PERIPROSTHETIC OSTEOLYSIS, RIGHT TOTAL KNEE REPLACEMENT".

  Patient problems: Injury; Osteolysis

  MAUDE report 8753507 ↗
• MalfunctionDec 27, 2018Break; Break

  WE RECEIVED A NOTICE ABOUT AN EVENT OCCURED AT (B)(6) HOSPITAL (ROME), BUT THE ONLY INFO ARE REF. AND BATCHES WITH NO OTHER EXPLANATION, ALREADY SENT A REQUEST OF INFO. AS PER ADDITIONAL INFORMATION RECEIVED: BREAKAGE OF INSERT LOCKING WIRE. CUSTOMER HAS CONFIRMED THAT PATIENTS DIDN¿T SUFFER ANY INJURY REGARDING THE EVENTS.

  Patient problems: Ambulation or Postural Difficulties; No Known Impact Or Consequence To Patient

  MAUDE report 8199236 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH MW 5079432 "TOTAL RIGHT HIP KNEE ARTHROPLASTY CAUSED DEBILITATION PAIN, STIFFNESS, RANGE OF MOTION LOSS REQUIRING 2009 MANIPULATION AND REVISION SURGERY ON 2013. MEDICAL DEVICE PARTS CAUSED METAL POISONING AND SEVERE ALLERGIES, REPEATED F/U OFFICE VISITS WITH SURGEON REPORTING PAIN, STIFFNESS, LOSS OF RANGE OF MOTION AND METAL POISONING. ATTENDED YEARS OF PHYSICAL THERAPY AND DAILY INTAKE OF PRESCRIPTION MEDICATION TO CONTROL SYMPTOMS. LENGTH OF TIME BETWEEN INITIAL SURGERY AND REVISION SURGERY CREATED DEBILITATING MEDICAL ISSUES AND PERMANENT DISABILITY. MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009 AND METAL POISONING". THIS PI IS FOR REVISION SURGERY IN (B)(6) 2013.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 7954215 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH MW 5079432 "TOTAL RIGHT HIP KNEE ARTHROPLASTY CAUSED DEBILITATION PAIN, STIFFNESS, RANGE OF MOTION LOSS REQUIRING 2009 MANIPULATION AND REVISION SURGERY ON 2013. MEDICAL DEVICE PARTS CAUSED METAL POISONING AND SEVERE ALLERGIES, REPEATED F/U OFFICE VISITS WITH SURGEON REPORTING PAIN, STIFFNESS, LOSS OF RANGE OF MOTION AND METAL POISONING . ATTENDED YEARS OF PHYSICAL THERAPY AND DAILY INTAKE OF PRESCRIPTION MEDICATION TO CONTROL SYMPTOMS. LENGTH OF TIME BETWEEN INITIAL SURGERY AND REVISION SURGERY CREATED DEBILITATING MEDICAL ISSUES AND PERMANENT DISABILITY. MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009 AND METAL POISONING". THIS PI IS FOR MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 7954018 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS EXPERIENCING PATELLA-FEMORAL PAIN AND PAIN IN POSTERIOR FEMUR. PLAN WAS TO RESURFACE PATELLA AND TO CHANGE INSERT AND LEG WAS HYPEREXTENDED.

  Patient problems: Injury

  MAUDE report 7789250 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7161767 ↗