Triathlon 5531-G-610-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327390575), received between Apr 13, 2020 and Aug 6, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K173849); 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 18, 2026.

Recalls naming this device

1. Feb 6, 2024Class IIOpen, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1260-2024 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Right knee revision, patient's right knee got infected. Surgeon removed and replaced the poly insert today. Hospital will not release more info.

  Patient problems: Unspecified Infection

  MAUDE report 50164827 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT'S POLY INSERT REVISED DUE TO INFECTION IN THE KNEE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25610707 ↗
• InjuryMay 1, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 6X10 CS INSERT WAS REVISED TO A 6X11 CS INSERT. NO DAMAGE, WEAR, OR POSITIONING ISSUES WERE NOTED FOR THE IMPLANTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25054619 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP REPORTED, PATIENT PRESENTED WITH A DRAINING SURGICAL WOUND. DR. OPTED TO PERFORM AN EXTENSIVE I&D AND "POLY SWAP". NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO. RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22899604 ↗
• InjuryJan 29, 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 INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21263329 ↗
• InjuryJan 23, 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 SUSPECTED INFECTION. AN I&D WAS PERFORMED AND A 6X10 CS INSERT WAS EXCHANGED FOR ANOTHER 6X10 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21216395 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. NOTED ON THE SHEET: "POLY SWAP I&D." A 6X10 CS INSERT WAS IMPLANTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21095564 ↗
• InjuryMar 13, 2024Unstable; Unstable

  AS REPORTED: "ON 2/21/2024 WE WERE SCHEDULED FOR A RETINACULAR REPAIR AND I&D OF A RIGHT TOTAL KNEE ARTHROPLASTY. UPON EXPOSURE TO THE JOINT, DR. NOTICED THAT THE 6X10 TIBIA INSERT WAS "ROCKING" IN THE TIBIAL TRAY. AFTER INSPECTION OF THE INSERT, IT APPEARED AS IF IT WAS CORRECTLY ENGAGED TO THE TIBIAL BASEPLATE, HOWEVER WAS STILL ROCKING POSTERIORLY. WE TOOK NOTE OF THIS AND ASSUMED THAT SOFT TISSUE WAS PREVENTING THE TIBIAL INSERT FROM FULLY LOCKING INTO THE BASEPLATE. WE PROCEEDED FORWARD WITH THE EXPLANT OF THE DEVICE, UPON WHICH DR. EXAMINED THE EXPLANTED 6X10 INSERT. HERE, HE NOTICED TWO "BEVELS ON THE POSTERIOR ASPECTS OF THE TIBIAL INSERT. HE EXPRESSED HIS CONCERNS THAT HE THOUGHT SOMETHING WASN'T CORRECT. HE CONTINUED WITH HIS SOFT TISSUE WORK, I&D, AND WE PROCEEDED TO TRIAL FOR A NEW POLY. ONCE WE CHOSE OUR NEW CS POLY, HE COMPARED THE TWO ON THE BACK TABLE. IT WAS HERE THAT WE NOTICED A DIFFERENCE IN THE TWO IMPLANTS. THE NEW 6X12 CS INSERT DID NOT HAVE THE "BEVELS" POSTERIORLY LIKE THE EXPLANTED 6X10 CS DID. WE THOUGHT MAYBE IT WAS DAMAGED WHEN INITIALLY IMPLANTED BUT THE BEVELS WERE ODDLY SYMMETRIC ON BOTH THE MEDIAL AND LATERAL ASPECT OF THE IMPLANT. UPON IMPLANTATION

  Patient problems: Joint Laxity; Pain

  MAUDE report 18892998 ↗
• InjuryDec 11, 2023Adverse 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 INFLAMMATION AND DRAINAGE. IT DID NOT APPEAR TO BE INFECTED, BUT THE PATIENT REPORTED AN ALLERGY TO METHYL METHACRYLATE (THIS ALLERGY WAS NOT REPORTED TO THE SURGEON PRIOR TO IMPLANTATION) IN THE SIMPLEX HV CEMENT USED. AN I&D WAS PERFORMED AND POLY INSERT WAS REVISED.

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 18307815 ↗
• MalfunctionJul 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, LEFT MAKO KNEE. IT WAS REPORTED THAT AFTER IMPACTION, ONE SIDE OF THE LOCKING WIRE WAS OBSERVED TO BE ABOVE THE RIM OF THE TIBIAL BASEPLATE. THE WIRE APPEARED TO HAVE BEEN MOLDED IN THE OPPOSITE DIRECTION IT SHOULD HAVE BEEN. MPS CONFIRMED THAT NO EXCESSIVE FORCE WAS USED DURING IMPACTION (IMPACTION CONSISTED OF 1 IMPACT), AND THAT IMPACTION WAS NOT PERFORMED ANYWHERE CLOSE TO THE WIRE. INSERT WAS REMOVED AND A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN A MINUTE. MPS HAS PROVIDED INTRA-OP PICTURES OF THE IMPLANT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286337 ↗
• InjuryFeb 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: PATIENT HAD BILATERAL MANIPULATION UNDER ANESTHESIA. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16290750 ↗
• InjuryJan 13, 2023Adverse 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. AS REPORTED: "PT. PRESENTED WITH A RED/SWOLLEN KNEE, WITH WHAT APPEARS TO BE AN ABSCESS OF A PREVIOUS SURGICAL INCISION. DR. OPTED TO PERFORM AN EXTENSIVE I&D AND SWAP OUT THE PT'S TRIATHLON X3 INSERT. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES. NO FURTHER INFO AVAILABLE."

  Patient problems: Abscess; Pain; Swelling/ Edema

  MAUDE report 16164942 ↗
• InjuryDec 22, 2022Unstable; Unstable

  REVISED A RIGHT KNEE TRIATHLON INSERT FROM A 6X10 CS TO A 6X12 CS DUE TO KNEE FEELING LOOSE.

  Patient problems: Joint Laxity

  MAUDE report 16039905 ↗
• MalfunctionMar 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  LOCKING WIRE CAME LOOSE ON POLY INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732807 ↗
• InjuryNov 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. REP STATED: "PATIENT CAME THROUGH ER WITH WOUND ISSUES. WAS BROUGHT INTO SURGERY FOR I&D AND SWAP OF LINER. REMOVAL IMPLANT/X-RAYS NOT AVAILABLE."

  Patient problems: Insufficient Information

  MAUDE report 10821363 ↗
• InjuryApr 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED FOR PATIENT'S RIGHT KNEE: "SWAPPED OUT THE POLY TODAY DUE TO INFECTION. NO X-RAYS AVAILABLE, NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9953684 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1653-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E