Triathlon 5537-G-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327027242), received between Sep 17, 2019 and Jun 23, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO MEDIAL PAIN AND PATELLAR CLUNKING. A 4X13 TS INSERT WAS EXCHANGED FOR ANOTHER, AND A COMPETITOR PATELLAR COMPONENT WAS REVISED TO A STRYKER PATELLAR COMPONENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 22309808 ↗
• InjuryJan 4, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH LEFT KNEE PAIN, INABILITY TO LIFT LEG, INCREASED KNEE SWELLING, PAIN WITH INITIATION OF WEIGHT BEARING, STIFFNESS OF THE KNEE WITH ATTEMPTED RANGE OF MOTION, BURNING WITH RANGE OF MOTION. TIBIAL INSERT WAS REVISED.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16094112 ↗
• InjuryNov 15, 2022Adverse 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 DISCOMFORT. SURGEON PERFORMED SOFT TISSUE REMOVAL AND EXCHANGED A 4X13 TS INSERT FOR A 4X16 PS INSERT (NO ALLEGATIONS AGAINST THE REVISED INSERT, SURGEON SAID THE PS INSERT 'FELT BETTER' WHILE TRIALING). REP PROVIDED PRIMARY USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Discomfort

  MAUDE report 15797321 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. OFFICE NOTE STATES THAT THE PATIENT PERCEIVED A LIMB LENGTH DISCREPANCY (LEFT LONGER THAN RIGHT) AND MILD SUBLUXATION OF THE PATELLA. A 4X13 TS INSERT AND COMPETITOR PATELLAR DEVICE WERE REVISED. REP PROVIDED OFFICE NOTES, SURGEON NOTES, PATHOLOGY REPORT AND IMPLANT SHEET FROM ORIGINAL STRYKER IMPLANTATION AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9897822 ↗
• InjuryJan 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT HAD AN INDEX SURGERY OUTSIDE THE RI, PRIOR TO CORS. IN (B)(6) 2014 DOCTOR REVISED THE PATIENT'S RIGHT KNEE FOR STIFFNESS, CHANGED ONLY THE POLY. NOW HE IS REVISING AGAIN THE PATIENT'S RIGHT KNEE FOR STIFFNESS (DISFUNCTION, ARTHROFIBROSIS) CHANGING ONLY THE POLY.

  Patient problems: Injury

  MAUDE report 9648915 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW, ON (B)(6) 2013, A ROM OF ONLY 0° TO 30° WAS REPORTED. PATIENT COULD NOT WALK AROUND, REQUIRED A LOT OF STRONG PAIN MEDICATION INCLUDING OXYCONTIN. THIS SECOND LEFT KNEE REVISION SURGERY WAS PERFORMED ON (B)(6) 2013, AGAIN ON THE INDICATION OF ARTHROFIBROSIS. NO REPORT OF BEARING EXCHANGE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 9361750 ↗
• InjuryNov 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW IN PI 2038833, IT WAS REPORTED THAT AT 1-YEAR POST SECOND REVISION, ON (B)(6) 2014, PATIENT COMPLAINED ABOUT SEVERE LEFT KNEE PAIN, VAS 10/10 SCALE, WITH LIMPING OF THE KNEE REQUIRING A CANE FOR WALKING SUPPORT. ON (B)(6) 2016 KNEE PAIN WAS STILL REPORTED AS PERSISTENT BUT NO KNEE ROM OR FLEXION WAS DOCUMENTED IN THE RECORDS. PATIENT WAS LAST SEEN ON (B)(6) 2018, WITH STILL PERSISTENT KNEE SYMPTOMS ALTHOUGH NO DETAILS ABOUT PAIN LEVEL OR KNEE ROM WERE DOCUMENTED IN THE (OTHERWISE PLENTIFUL) RECORDS. AN MRI OF THE LEFT KNEE WAS MADE ON (B)(6) 2018, BUT DID NOT SHOW ANY DEVICE PATHOLOGY AS FAR AS EVIDENT FROM THE PICTURES WITH OBVIOUS DEVICE DEFORMATION DESPITE USE OF MARS MRI (METAL ARTEFACT REMOVAL SOFTWARE MRI).

  Patient problems: Pain

  MAUDE report 9361744 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW FOR PI 2038833, IT WAS REPORTED THAT POST REVISION REHABILITATION WAS COMPLICATED BY OCCURRENCE OF A HEMATOMA IN THE KNEE REQUIRING ARTHROSCOPIC SURGICAL EVACUATION WITH DEBRIDEMENT ON (B)(6) 2012. MOST OF THE HEMATOMA WAS IN THE SUPRA PATELLAR POUCH PLUS MEDIAL AND LATERAL GUTTERS OF THE KNEE. THE TOTAL KNEE COMPONENTS WERE UNREMARKABLE AND REMAINED IN PLACE.

  Patient problems: Hematoma; Injury

  MAUDE report 9354010 ↗
• InjurySep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO WOUND DRAINAGE. IT WAS UNKNOWN IF INFECTION WAS PRESENT, CULTURES TAKEN INTRA-OPERATIVELY WERE SENT FOR TESTING. A WASH-OUT WITH POLY SWAP WAS PERFORMED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9077838 ↗