Optetrak Logic 02-010-01-0260Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862001184), received between Feb 22, 2021 and Feb 18, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 reports).

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 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 18, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND A LOOSE FEMUR. AS A RESULT, THEY WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24376863 ↗
• InjuryNov 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 89 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. ADDITIONALLY REPORTED, "REASON FOR REVISION: FEMORAL KNEE DEBONDING/LOOSENING AND ACUTE PAIN OF LEFT KNEE." THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Discomfort; Muscle Weakness/Atrophy; Pain

  MAUDE report 23515930 ↗
• InjuryMar 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA MEDWATCH, PATIENT HAD KNEE REPLACEMENT DONE THREE YEARS AGO. IN 2023, PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING, PATIENT HAD X-RAY DONE AND THE PHYSICIAN CONFIRMED THAT THE PATIENT WOULD NEED KNEE REPLACEMENT AGAIN DUE TO A RECALL ON THE PRODUCT. PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Cyst(s); Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21516411 ↗
• InjuryFeb 20, 2025Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL BRIEF, ON (B)(6) 2017, PATIENT UNDERWENT A LEFT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. IN (B)(6) 2019, A BONE SCAN REVEALED STRESS SHIELDING AND POSTERIOR AND SUPERIOR FEMORAL EFFUSION. PATIENT WAS DIAGNOSED WITH CONTINUED PAIN IN LEFT KNEE AND CONTINUED EFFUSION OF LEFT KNEE. THUS, DUE TO WORSENING PAIN, EFFUSION, CHRONIC SYNOVITIS, SWELLING, LOSS OF RANGE OF MOTION, LEFT FOOT DROP, AND FINDINGS OF ¿RADIOGRAPHS AND PHYSICAL EXAM OF LEFT TOTAL KNEE ARTHROSCOPY ARE CONSISTENT WITH POLYETHYLENE WEAR¿, PATIENT IS SCHEDULED FOR A LEFT KNEE REPLACEMENT REVISION SURGERY IN (B)(6) 2023 TO REMOVE THE DEFECTIVE OPTETRAK DEVICE. UPON INFORMATION AND BELIEF, THE EFFUSIONS, SYNOVITIS, SWELLING, PAIN, AND LIMITED RANGE OF MOTION ARE DUE TO POLYETHYLENE WEAR.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21426348 ↗
• InjuryNov 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 6 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING - FEMORAL. THE PATIENT WAS EXPERIENCING SYNOVITIS, SWELLING/EDEMA, PAIN, AND OSTEOLYSIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20659012 ↗
• InjuryJul 25, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS AND 2 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT, AND THE FEMORAL COMPONENT DEBONDED FROM THE CEMENT. EVERYTHING WAS REMOVED AND REPLACED WITH COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19826918 ↗
• InjuryAug 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS 56 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSENING FEMUR. PATIENT ALSO COMPLAINED OF KNEE PAIN. EXPLANTED AND REVISED WITH COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. NO PHOTOS OR X-RAYS PROVIDED. PRODUCT IS NOT BEING RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 17478832 ↗
• InjuryNov 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE REPORTED EVENT IS UNRELATED TO BREAKAGE OF A DEVICE & DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain; Scar Tissue

  MAUDE report 15883277 ↗
• InjuryFeb 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POST THE INITIAL IMPLANT, THIS (B)(6) Y/O MALE PATIENT HAD A LEFT KNEE REVISION DONE BASED ON THE FEMUR BEING LOOSE. THE REVISION WAS DONE BY A COMPETITOR THAT TOLD THE REP THAT A REVISION WAS BEING DONE AND THIS MANUFACTURER¿S IMPLANTS WERE BEING REMOVED. THE DEVICES WILL BE RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Cyst(s); Failure of Implant; Inadequate Osseointegration; Joint effusion; Osteolysis

  MAUDE report 11362242 ↗

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 Inserts,
• 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