Triathlon 5531-G-511-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327336450), received between Jun 2, 2020 and Aug 27, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

7 other recalls cover devices cleared under the same FDA submission (K172634); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Unstable

  Patient problems: Joint Laxity

  MAUDE report 50465563 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX RIGHT TKA ON (B)(6) 2023. PATIENT PRESENTED WITH PJI AND UNDERWENT REVISION ON (B)(6) 2023. ONLY THE LINER WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 21373393 ↗
• InjuryJul 23, 2024Mechanical Problem; Unstable; Mechanical Problem; Unstable

  AS REPORTED: "REV RTKA W/ POLY EXCHANGE WITH FLEXION INSTABILITY. GOING TO PS POLY. PATIENT APPEARED TO HAVE MID FLEXION INSTABILITY BUT WAS STIFF IN EXTENSION. SO SURGEON DID SOFT TISSUE EXCISIONS AND DECREASED THE POLY THICKNESS AND PUT IN PS. CS POLY THAT CAME OUT WAS NORMAL." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 19812206 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED. RTKA WITH EXTENSOR MECHANISM REPAIR. 5531-G-511. LOT# E532EV- CAME OUT AND REPLACED WITH THICKER POLY. WE USED A SCREW TO SECURE THE MESH TO MAKE A NEW EXTENSOR MECHANISM (MARKED MESH. IT IS USED TO RECREATE THE EXTENSOR MECHANISM). OLD POLY LOOKED FINE, THE PATIENT HAD NO EXTENSOR MECHANISM.

  Patient problems: Insufficient Information

  MAUDE report 18594352 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REV. RTKA DUE TO RIGHT KNEE INFECTION. EXPLANT: 5/11 CS INSERT - IMPLANT: 5/14 CS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 18510289 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH STRYKER FACEBOOK PAGE: IT HAS BEEN THREE YEARS SINCE MY KNEE REPLACEMENT. I AM STILL IN THE SAME OR WORSE PAIN THAN BEFORE IT WAS DONE. I STILL HAVE GREAT DIFFICULTY WITH STAIRS. RIGHT KNEE. UPDATE: DIFFICULTY WALKING UP STAIRS, PAIN AND HEARS A "SNAPPING NOISE".

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17859629 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HAVING A RIGHT KNEE MANIPULATION UNDER ANESTHESIA AND ARTHROSCOPIC LYSIS OF ADHESIONS DUE TO ARTHROFIBROSIS ON (B)(6) 2022. UPDATE: SPOKE WITH PATIENT WHO STATED THAT HE WILL BE SEEING HIS DOCTOR ON (B)(6) 2023 TO DETERMINE IF A REVISION WILL BE DONE. PATIENT STATES HE IS "LEANING TOWARDS HAVING THE REVISION DONE AS HE IS EXPERIENCING BACK AND BILATERAL HIP PAIN".

  Patient problems: Fibrosis; Pain; Swelling/ Edema

  MAUDE report 16493394 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT REPORTED HAVING A RIGHT KNEE MANIPULATION UNDER ANESTHESIA DUE TO PAIN AND SWELLING ON (B)(6) 2022.

  Patient problems: Fibrosis; Pain; Swelling/ Edema

  MAUDE report 16022596 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT REPORTED HAVING A RIGHT KNEE MANIPULATION UNDER ANESTHESIA DUE TO PAIN AND SWELLING ON (B)(6) 2022.

  Patient problems: Fibrosis; Pain; Swelling/ Edema

  MAUDE report 16022594 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE CONTINUED PAIN AFTER MANIPULATION & RECALL INQUIRY. PATIENT LEFT VOICEMAIL REGARDING A RECALL INQUIRY FOR A TRIATHLON PRESS FIT SIZE 5. UPDATE: PATIENT HAD PRIMARY RIGHT KNEE ARTHROPLASTY ON (B)(6) 2022. PATIENT REPORTED TWO MANIPULATIONS UNDER ANESTHESIA AND AN ARTHROSCOPY DUE TO PAIN AND SWELLING. PATIENT NOTED SURGEON WANTS TO PERFORM A REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15994041 ↗
• InjuryNov 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  LEFT KNEE MANIPULATION ON (B)(6 )2022.

  Patient problems: Insufficient Information

  MAUDE report 15832289 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL SIMULTANEOUS INDEX TKA ON (B)(6) 2020. PATIENT COMPLAINS OF LEFT PAIN AND SUSPICION OF PJI. UNDERGOES REVISION ON (B)(6) 2021 FOR PJI. I&D AND POLY EXCHANGE ONLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12817736 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION TODAY WAS DONE FOR INFECTION." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS FOR THE PATIENT'S RIGHT KNEE. A 5X11 CS INSERT WAS EXCHANGED FOR ANOTHER 5X11 CS INSERT. SPOKE TO REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL AND SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12148691 ↗
• InjuryJun 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  POLY SWAP FOR INFECTION. NO ADDITIONAL INFORMATION WAS GIVEN ABOUT PATIENT OR PROCEDURE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10108801 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E