Triathlon 5530-G-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327050448), received between Nov 19, 2018 and Apr 22, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Fracture; Fracture

  REVISION OF POLYETHYLENE IMPLANTED IN 2016. POLYETHYLENE BROKEN AT POSTERIOR PART. ALL PIECES REMOVED FROM PATIENT AND NEW POLYETHYLENE INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 21882496 ↗
• MalfunctionApr 8, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  TRIATHLON WAS USED FOR A PATIENT IN TKR SURGERY. WHILE IMPLANTING SURGEON FOUND THAT THE TIBIAL INSERT LOCKING PIN GOT DISENGAGED WHILE IMPACTING INTO THE BASE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059306 ↗
• InjuryMar 13, 2023Material Erosion; Fracture; Unstable; Insufficient Device Problem Information; Material Erosion; Fracture; Unstable; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: KNEE REVISION. UPDATE 28 MAR 2023 - MEDICAL REVIEW STATES: IN THIS PARTICULAR CASE THE FEMORAL COMPONENT WAS PLACED POSTERIOR TO ITS IDEAL POSITION AND THE TIBIAL IMPLANT WAS PLACED IN A GREATER DEGREE OF FLEXION THAN IDEAL.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 16535038 ↗
• InjuryMar 13, 2023Material Erosion; Fracture; Unstable; Insufficient Device Problem Information; Material Erosion; Fracture; Unstable; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: KNEE REVISION. UPDATE: REVISION DUE TO INSTABILITY.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 16535037 ↗
• InjuryFeb 15, 2023Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED, "TRIATHLON INLAY 11MM DELAMINATED AFTER 8 YEARS."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16377745 ↗
• InjuryMay 9, 2022Degraded; Unstable; Degraded; Unstable

  THE FOLLOWING WAS REPORTED: KNEE REVISION DUE TO INSTABILITY IN THE KNEE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14342945 ↗
• InjuryNov 16, 2021Material Erosion; Fracture; Unstable; Material Erosion; Fracture; Unstable

  IT HAS BEEN REPORTED "KNEE REVISION DUE TO INSTABILITY".

  Patient problems: Joint Laxity

  MAUDE report 12822184 ↗
• InjuryJul 7, 2021Degraded; Degraded

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2009 WHERE SHE WAS IMPLANTED WITH A STRYKER KNEE SYSTEM. IT IS FURTHER ALLEGED THAT THE PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2016. THE SURGEON NOTED THAT UPON ENTRY INTO THE KNEE JOINT, THERE WAS NOTED TO BE ABUNDANT METALOSIS WITH SYNOVITIS PRESENT CONSISTENT WITH METAL WEAR. UPDATE AS PER THE LEFT KNEE REVISION OP REPORT, THERE WAS NOTED TO BE COMPLETE WEAR OF THE POLYETHYLENE LINER ON THE LATERAL ASPECT OF THE KNEE AND POSTERIORLY ALONG THE TIBIAL BASEPLATE. THERE HAD BEEN CLEAR RUBBING OF THE FEMORAL COMPONENT ON THE POSTERIOR ASPECT OF THE TIBIAL BASEPLATE, WHICH CREATED THE METALOSIS.

  Patient problems: Inflammation; Synovitis

  MAUDE report 12132542 ↗
• InjuryApr 19, 2021Unstable; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11691406 ↗
• InjuryNov 18, 2019Unstable; Unstable

  IT WAS REPORTED BY THE SALES REP THAT PATIENT REPORTED TO SURGEON THAT EXPERIENCE LIGAMENT LAXITY AND INSTABILITY. INITIAL PLACEMENT OF IMPLANT WAS APPROPRIATE. SURGEON TRAILED WITH A THICKER INSERT (13, 16MM) WHICH WAS STABLE IN EXTENSION BUT TOO TIGHT IN FLEXION. HENCE, SURGEON OPTED FOR CHANGE TO COMPETITOR HINGE TO ENSURE EXTENSION-FLEXION STABILITY AND ALSO TO MAKE SURE THAT PATIENT DOES NOT GO INTO RECURVATUM (STRYKER TRIATHLON DOES NOT HAVE A HINGE). OLD TRIATHLON IMPLANT (DONE ON 2 (B)(6) 2017) WAS RETURNED TO PATIENT.

  Patient problems: Injury

  MAUDE report 9335146 ↗
• InjuryJun 19, 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 " LEFT TOTAL KNEE ARTHROPLASTY WITH LAXITY AND PAIN".

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

  MAUDE report 8712662 ↗
• InjuryJun 11, 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 "STATUS POST LEFT TOTAL KNEE ARTHROFIBROSIS "

  Patient problems: Injury; Scar Tissue

  MAUDE report 8687082 ↗
• InjuryMay 1, 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 THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO CHRONIC INFLAMMATION, STATUS POST INCISION AND DRAINAGE, SYNOVECTOMY AND LINER EXCHANGE, POSSIBLE ACUTE VERSUS CHRONIC INFECTION, LEFT KNEE."

  Patient problems: Inflammation; Injury; Unspecified Infection

  MAUDE report 8568444 ↗
• InjuryMar 14, 2019Unstable; Unstable

  A TRIATHLON THAT WAS INITIALLY IMPLANTED, WAS REVISED ON (B)(6) 2019. IT HAD BEEN IMPLANTED ON (B)(6) 2017. THE REASON FOR REVISION WAS THE PATIENT HAD A FALL AND THE DOCTOR WAS CONCERNED ABOUT THE STABILITY OF THE MEDICAL COLLATERAL LIGAMENT AND WANTED TO PUT A THICKER POLYETHYLENE LINER IN TO INCREASE STABILITY OF THE CONSTRUCT. THIS WAS DONE ON (B)(6) "219". A SIZE 3 CR 11MM INSERT WAS REMOVED AND A SIZE 3 CR 19MM INSERT WAS IMPLANTED. THE 11MM INSERT THAT WAS REMOVED APPEARED HAVE SOME YELLOWING IN THE MEDIAL CONCAVITY. THE DOCTOR WAS CONCERNED THAT THIS LOOKED LIKE AN OXIDATION MARK.

  Patient problems: Fall; Injury

  MAUDE report 8420494 ↗
• InjuryFeb 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED "PROGRESSIVE PAIN AND SWELLING OVER LAST YEAR. ELEVATED CELL COUNT AND APPEARANCE OF INFECTION, BUT POLY WEAR MUCH MORE AGGRESSIVE WEAR THAN WOULD EXPECT".

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 8367651 ↗
• InjuryFeb 5, 2019Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO A FRACTURED TIBIAL INSERT. INTRA-OPERATIVELY, THE TIBIAL INSERT WAS FOUND TO BE FRACTURED IN THE MEDIAL POSTERIOR ASPECT.

  Patient problems: Injury

  MAUDE report 8304728 ↗
• InjuryJan 7, 2019Unstable; Unstable

  EVENT: SURGEON DETERMINED KNEE WAS UNSTABLE. HE REMOVED FEMORAL COMPONENT AND INSERT. HE IMPLANTED TS FEMORAL COMPONENT WITH THICKER INSERT. PATIENT STABLE. NO COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 8222258 ↗
• InjuryNov 19, 2018Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, THE POLY WAS FOUND TO BE NOTICEABLY DAMAGED ON THE RIGHT SIDE MOST POSTERIOR ASPECT OF THE DEVICE. PATIENT'S 11 MM CR INSERT WAS REVISED TO A 16 MM INSERT.

  Patient problems: Injury

  MAUDE report 8086733 ↗