Optetrak Logic 02-012-41-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862003133), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K093360); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 126 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, OSTEOLYSIS WITH LOOSENING OF HER LEFT TOTAL KNEE REPLACEMENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND NOTED OSTEOLYSIS, THE POLYETHYLENE INSERT WITH OXIDATION AND WEAR/BREAKAGE AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. PATELLAR COMPONENT WAS INSPECTED, IT WAS WELL FIXED AND WELL POSITIONED WITHOUT ANY SIGNIFICANT WEAR AND THEREFORE WAS RETAINED. THE PATIENT WAS REVISED TO A COMPETITOR'S COMPONENTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 20843224 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inser
• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ