Skip to content

Tri-plus 138-3606Recalls & reported problems

Ortho Development Corporation · 36mm +6 CoCr · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409016402), received between Dec 13, 2019 and Dec 13, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT RECEIVED TOTAL HIP ARTHROPLASTY ON (B)(6) 2019 AND WAS REVISED ON (B)(6) 2019 TO REPLACE THE FEMORAL HEAD. INFECTION WAS REPORTED AS THE REASON FOR THE REVISION. NO FURTHER INFORMATION WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Patient problems: No Information

    MAUDE report 9468133 ↗

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.