Triathlon 5530-G-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327050509), received between Dec 29, 2017 and Dec 14, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT BOOKED IN FOR REVISION KNEE SURGERY (TIBIAL INSERT SWAP AND PATELLA RESURFACING). SURGEON REPORTED THAT PATIENT¿S RIGHT KNEE WAS ¿LOOSE¿. DURING THE REVISION SURGERY, THE TIBIAL INSERT WAS EXPLANTED, AND SEVERE DETERIORATION OF THE POSTEROLATERAL SURFACE OF THE TIBIAL INSERT WAS NOTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15977640 ↗
• InjuryMar 2, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT HAS BEEN REPORTED "SUDDEN LOCKING IN KNEE. VERY ACTIVE PATIENT. WEAR OF POLY POSTERIOR".

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13652050 ↗
• InjurySep 8, 2021Unstable; Naturally Worn; Unstable; Naturally Worn

  THE FOLLOWING WAS REPORTED: KNEE REVISION FOR INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12441497 ↗
• InjuryAug 24, 2021Fracture; Fracture

  REVISED TRIATHLON TIBIA DUE TO INSTABILITY. POLY INSERT WAS FOUND TO HAVE BROKEN FRAGMENTS OFF POSTERIOR EDGES MEDIAL & LATERAL.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12357641 ↗
• InjuryFeb 24, 2021Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, THE INSERT WAS FOUND BROKEN IN THE POSTERIOR MEDIAL ASPECT. THE LINER AND A SIZE 4 CR FEMORAL COMPONENT WERE REVISED TO CONVERT THE PATIENT TO A PS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 11371836 ↗
• InjuryNov 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO POSTERIOR FAILURE OF THE POLY INSERT AND WEAR OF THE PATELLAR COMPONENT. SURGERY OCCURRED ON (B)(6) 2020. ON (B)(6) 2020, REVISING SURGEON DISCOVERED THAT A RIGHT SIDED FEMORAL COMPONENT WAS IMPLANTED INTO THE LEFT KNEE APPROXIMATELY 8 YEARS AGO (BY A SURGEON WHO IS NOW RETIRED). REP WAS NOT PRESENT FOR THAT PROCEDURE. INTRA-OPERATIVELY, THE FEMORAL COMPONENT WAS DEEMED TO BE WELL-FIXED AND WAS NOT REVISED. THE PATELLAR COMPONENT AND A 4X13 CR INSERT WERE REVISED TO A NEW PATELLAR COMPONENT AND CS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 10819671 ↗
• InjuryJun 30, 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. NOTED ON THE USAGE SHEET: "LIMITED RANGE OF MOTION. NO OTHER INFORMATION IS AVAILABLE DUE TO SEALED ELECTRONIC MEDICAL RECORDS." A 4X13 CR INSERT WAS REVISED TO A 4X11 CR INSERT. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 10210742 ↗
• InjurySep 4, 2019Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE RIGHT TOTAL KNEE RULE OUT SEPTIC LOOSENING." * UPDATED ON 08-AUG-2019 BY QS BASED ON MEDICAL REVIEW: "AT 1-YEAR POST PRIMARY, ON (B)(6) 2013, PATIENT PRESENTED WITH SUDDEN CALF PAIN AND SWELLING." "TWO YEARS WENT BY UNTIL ON (B)(6) 2015, PATIENT PRESENTED AGAIN WITH PROGRESSIVE KNEE PAIN ON WEIGHT- BEARING WITH NUMBNESS AND UNSTEADY FEELINGS IN THE KNEE, STILL REQUIRING CANE SUPPORT FOR WALKING. KNEE FLEXION HAD DECREASED TO 90° WITH A STILL STABLE KNEE AS REPORTED." "A FEW MONTHS LATER, IN (B)(6) 2015, KNEE FUNCTIONALITY HAD FURTHER DECREASED TO 75° OF FLEXION WITH DIFFICULTY EXTENDING THE KNEE AND NEW STIFFNESS COMPLAINTS. "ON (B)(6) 2017, PATIENT PRESENTED AGAIN WITH A PROGRESSIVE VALGUS DEFORMITY OF THE RIGHT KNEE AND LIMITED FLEXION/EXTENSION RANGE OF 5° - 90°. SWELLING OF THE KNEE WAS PRESENT WITH PAIN ON BOTH MEDIAL AND LATERAL SIDE OF THE RIGHT KNEE. THE KNEE WAS UNSTABLE IN VALGUS. AN X-RAY OF THE RIGHT KNEE WAS REPORTED TO SHOW SEVERE OSTEOLYSIS ALONG ANTERIOR AND POSTERIOR FLANGES OF THE FEMORAL COMPONENT WITH GROSS LOOSENING AND 20° OF VALGUS DEFORMITY WHILE ON

  Patient problems: Inadequate Osseointegration; Injury; Loss of Range of Motion; Osteolysis; Unspecified Infection

  MAUDE report 8959622 ↗
• InjuryOct 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S LEFT KNEE DUE TO INFECTION (UNKNOWN IF INFECTION CLINICALLY CONFIRMED OR IDENTIFIED). ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER PLACED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7934045 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE IRRIGATION & DEBRIDEMENT OF PATIENT'S RIGHT KNEE DUE TO INFECTION ON (B)(6) 2017. IN REPORTING A STAGE 2 REVISION OF PATIENT'S RIGHT KNEE ON (B)(6) 2018, REP REPORTED THAT AN IRRIGATION AND DEBRIDEMENT OF SOFT TISSUE WAS PERFORMED ON (B)(6) 2017 DUE TO INFECTION, WITHOUT ENTERING THE JOINT SPACE. REP WAS NOT PRESENT FOR THE PROCEDURE AND HAS NO ACCESS TO ANY FURTHER INFORMATION DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7897724 ↗
• InjuryJun 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT COMPLAINS OF LATERAL PAIN IN FLEXION. ALL AVAILABLE INFORMATION IS SUBMITTED". A SIZE 4 13MM CR INSERT AND A METAL-BACKED PATELLA WERE REVISED TO A SIZE 4 16MM CR INSERT AND ASYMMETRIC PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 7604872 ↗
• InjuryDec 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF RIGHT KNEE WAS PERFORMED. REASON FOR REVISION IS DUE TO INFECTION, IRRIGATION & INSERT SWAP.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7155220 ↗