Triathlon 5531-G-711Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327046038), received between Jun 1, 2017 and Feb 14, 2022 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRESENTED WITH KNEE PAIN, LINER SWAP WITH SCAR TISSUE REMOVAL.

  Patient problems: Pain; Scar Tissue

  MAUDE report 13521657 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED TODAY WITH AN ACUTE-INFECTION OF THE LEFT KNEE, REQUIRING A THOROUGH I&D AND INSERT SWAP."

  Patient problems: Unspecified Infection

  MAUDE report 11364551 ↗
• InjuryNov 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  I&D PERFORMED WITH A POLY INSERT SWAP. DOCTOR WASHED KNEE THEN SINCE JOINT CAPSULE WAS OPENED HE REMOVED OLD INSERT WASHED AND PLACED A NEW INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 10874103 ↗
• InjuryMay 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT RIGHT KNEE REPLACEMENT (B)(6) 2018. THE PATIENT HAD RIGHT KNEE PERIPROSTHETIC JOINT INFECTION AND UNDERWENT RIGHT KNEE REVISION. ALL COMPONENTS EXCHANGED IN (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10043236 ↗
• MalfunctionJun 5, 2019Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT WHEN OPENED, THE DEVICE HAD WHAT APPEARED TO BE A LONG BLACK HAIR WRAPPED AROUND IT. DUE TO STERILITY CONCERNS, THE IMPLANT WAS NOT USED. A SECOND DEVICE OF THE SAME CATALOG NUMBER (DIFFERENT LOT) WAS OBTAINED AND IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN ONE MINUTE. REP PROVIDED THE USAGE SHEET SHOWING THE WASTED IMPLANT AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670465 ↗
• InjuryOct 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED STATING HE HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2012. HE STARTED EXPERIENCING DISCOMFORT IN 2017.

  Patient problems: Discomfort

  MAUDE report 7960467 ↗
• InjuryFeb 27, 2018Scratched Material; Insufficient Device Problem Information; Scratched Material; Insufficient Device Problem Information

  PATIENT HAD A PRIMARY TOTAL KNEE ON (B)(6) 2017 AND IT BECAME INFECTED AND SURGEON REMOVED THE PRIMARY INSERT, WASHED OUT THE JOINT, AND PUT IN A NEW INSERT.

  Patient problems: Injury; Pain; Swelling; Unspecified Infection

  MAUDE report 7299585 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REP REPORTED THE FOLLOWING: "PATIENT'S RIGHT KNEE COMPONENTS WERE REVISED DUE TO INFECTION, ALL 4 COMPONENTS REMOVED AND REPLACED WITH A SPACER. INITIAL OP DATE WAS (B)(6) 2017 [SIC] AND IT WAS OF A PRIMARY COMPONENT. NO IMPLANTS RETURNED PER HOSPITAL POLICY. ALL INFORMATION AVAILABLE TO ME IS INCLUDED IN THIS PI AND ATTACHMENT."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6858400 ↗
• InjuryJun 1, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  WOUND DEHISCENCE AND JOINT INFECTION AFTER LEFT TKR.

  Patient problems: Injury; Unspecified Infection; Wound Dehiscence

  MAUDE report 6605829 ↗