PANGEA 662238Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327413731), received between Dec 15, 2025 and Mar 31, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Device Difficult to Setup or Prepare; Malposition of Device

  DR. (B)(6) REPORTED THE FEEDBACK ON HIS SECOND CASE, IN WHICH HE IMPLANTED A DISTAL MEDIAL FEMUR STRUT AND A DISTAL LATERAL FEMUR STRUT (DUAL-PLATE CONSTRUCT) IN PRESENCE OF PROSTHESES IN BOTH THE HIP AND THE KNEE JOINTS (MANUFACTURER(S) OF PROSTHESES UNKNOWN) HIS FEEDBACK ON EVALUATED ASPECTS IS ALL POSITIVE AND THE FOLLOWING COMMENTS WERE INCLUDED IN THE SUBMITTED FORM: "THE 4.0 LOCKING SCREWS WERE DIFFICULT TO LOCKING INTO THE PLATE AT A VARIABLE ANGLE. THIS HAS BEEN AN ISSUE IN THE PAST WITH THE 4.0 LOCKING SCREWS IN OTHER PANGEA LARGE FRAG PLATES ALSO." [PROVIDED AS AN ADDITIONAL COMMENT ON THE PRODUCT AND PROCEDURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739672 ↗
• InjuryDec 15, 2025Migration; Migration

  AS REPORTED: "A LARGE FRAGMENT PANGEA PERIPRO INTERPROSTHETIC PLATE WAS USED TO TREAT A MIDSHAFT PERIPROSTHETIC FEMUR FRACTURE. SHORTLY AFTER INITIAL SURGERY DATE ((B)(6) 2025), THE SURGEON NOTICED THE MOST PROXIMAL T20 4.0 PANGEA LOCKING SCREW WAS BEGINNING TO BACK OUT OF THE PLATE. THE SCREW SEQUENTIALLY BACKED OUT OF THE LOCKING MECHANISM AT EACH POST-OPERATIVE VISIT UNTIL THE SCREW FULLY BACKED OUT AND SLID ALL THE WAY DOWN TO HER DISTAL FEMUR". PATIENT HAD TO BE BROUGHT BACK INTO OPERATING ROOM 16 WEEKS POST OPERATIVELY TO REMOVE BACKED OUT HARDWARE (NOW SITTING ADJACENT TO THE DISTAL FEMUR).

  Patient problems: Insufficient Information

  MAUDE report 23810453 ↗