Optetrak Logic 02-010-03-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862158116), received between Feb 14, 2020 and Apr 20, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K111400); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS AND COMPONENT LOOSENING. AS A RESULT, APPROXIMATELY NINE YEARS AND SIX MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT THERE WAS SIGNIFICANT REACTIVE TISSUE ABOUT BOTH THE FEMORAL AND TIBIAL COMPONENTS, THEY WERE GROSSLY LOOSE, THERE WAS GROSS FRACTURE OF THE POLYETHYLENE. THE PATELLAR BUTTON HAD MINIMAL ABRASIVE WEAR. THERE WAS A LOT OF OSTEOLYTIC DEBRIS PRESENT THROUGHOUT THE KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 FOR THIS EVENT/PATIENT.

  Patient problems: Discomfort; Joint effusion; Osteolysis; Pain

  MAUDE report 24927059 ↗
• InjuryFeb 11, 2025Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, BALANCE PROBLEMS, IMPLANT PAIN, JOINT LAXITY, LOSS OF RANGE OF MOTION, OSTEOLYSIS, SCAR TISSUE, AND SWELLING/EDEMA. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 21354428 ↗
• InjuryJan 24, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - USA. PATIENT ID: (B)(6). (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. HE HAD RIGHT KNEE REVISION ON (B)(6) 2017, APPROXIMATELY 4 YEARS 9 MONTHS AFTER THEIR INITIAL REPLACEMENT SURGERY. POSTOPERATIVE DIAGNOSIS: FRACTURED POLYETHYLENE FAILURE WITH POLYETHYLENE DEBRIS RESULTING IN SEVERE SYNOVITIS. LOOSE FEMORAL COMPONENT WAS PRESENT. POST OP VISIT OF (B)(6) 2017- PATIENT HAS RESUMED ALL ACTIVITIES WITHOUT RESTRICTION. NO INSTABILITY OR PAIN, HAS VERY GOOD RANGE OF MOTION AND NO OTHER SYMPTOMS. 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. (B)(6) 02-012-49-3009 - LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. RECALL: Z-0021-2022. CONCOMITANTS: (B)(6) 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. (B)(6) 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. (B)(6) 1510-S - CEMEX SYSTEM FAST 70 GM. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 620

  Patient problems: Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 21233785 ↗
• InjuryJan 10, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, JOINT LAXITY, PAIN, SWELLING AND EDEMA.. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21125399 ↗
• InjuryDec 5, 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 RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. UPON INSPECTION THERE WAS SEVERE DELAMINATION WEAR ON THE SURFACE OF THE POLYETHYLENE. BOTH TIBIAL AND FEMORAL COMPONENTS HAD AREA OF SEVERE OSTEOLYSIS LEADING TO DEBONDING AT THE BONE CEMENT JOINT. PATELLAR COMPONENT FOUND TO BE SIGNIFICANTLY WORN. THE PATIENT TOLERATED THE PROCEDURE WELL. 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: Implant Pain; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 20855274 ↗
• InjuryJan 26, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS POSTOP THE INITIAL IMPLANT, THE FEMALE PATIENT WAS TAKEN TO THE OR FOR CONTINUED RIGHT PAIN IN THE KNEE AND A REVISION WAS INDICATED. THE FEMORAL COMPONENT DID NOT APPEAR TO BE LOOSE BUT UPON REMOVING IT WITH OSTEOTOMES THE FEMUR EASILY DISASSOCIATED FROM THE CEMENT MENTAL MANTLE. THE PATIENT WAS SUCCESSFULLY REVISED TO A CC SIZE 3 FEMUR WITH A 14 X 40 STEM AND DISTAL AND POSTERIOR AUGMENTS OF 5MM BILATERALLY. THE DOCTORS ARE UNCLEAR IF THE FEMORAL COMPONENT WAS THE ACTUAL CAUSE OF THE PAIN HOWEVER UPON REMOVING IT, THEY DID FEEL UNCOMFORTABLE WITH HOW EASILY IT DETACH FROM THE CEMENT MANTLE BUT REVISION SURGERY WAS SUCCESSFUL PERFORMED. THE PATIENT WAS LEFT IN STABLE CONDITION. DEVICE NOT RETURNING PER FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 11229331 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2013. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A LOGIC - CRUCIATE RETAINING - CEMENTED FEMORAL COMPONENT - RIGHT - SIZE 3 (CATALOG 02-010-03-0330, SERIAL (B)(4)), LOGIC - FIT - CEMENTED TIBIAL TRAY - SIZE 3F/3T (CATALOG 02-012-45-3030, SERIAL (B)(4)), LOGIC - CRUCIATE RETAINING TIBIAL INSERT - SIZE 3 9MM SLOPE + (CATALOG 02-012-48-3009, SERIAL (B)(4)) AND STRYKER ANTIBIOTIC LOADED MEDIUM VISCOSITY BONE CEMENT (CATALOG 61971001, SERIAL (B)(4)). ON (B)(6) 2015, APPROXIMATELY 19 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY. THE EXACTECH WERE REMOVED AND REPLACED WITH NO 4 TOTAL STABILIZER FEMORAL COMPONENT RIGHT, NO 4 TOTAL STABILIZER UNIVERSAL BASEPLATE AND NO 4 TRIATHLON TS PLUS TIBIAL INSERT X3 13MM.

  Patient problems: Failure of Implant

  MAUDE report 9715035 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013