Optetrak Logic 02-012-48-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862159182), received between Sep 28, 2021 and Sep 16, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20229305 ↗
• InjuryAug 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: PRE-OP AND POST-OP DIAGNOSES INDICATED MECHANICAL FAILURE LEFT KNEE REPLACEMENT SECONDARY TO RECALL. DURING REVISION, IT WAS FOUND THAT THERE WAS GROSSLY DELAMINATED POLYETHYLENE WITH FRACTURING OF THE PLASTIC ITSELF PARTICULARLY MEDIALLY. FREE-FLOATING FRAGMENTS WITHIN THE KNEE JOINT. A COMPLETE SYNOVECTOMY WAS PERFORMED AND SENT FOR CULTURE. THE TIBIAL INSERT WAS REMOVED AND DEMONSTRATED SUBSTANTIAL DELAMINATION AND FRAGMENTATION OF THE MEDIAL SIDE WITH ESSENTIALLY PIECES MISSING. THERE WAS NO METAL-ON-METAL CONTACT NOR WAS THERE EVIDENCE OF METALLOSIS WITHIN THE JOINT ITSELF. THERE DID NOT APPEAR TO BE ANY GROSS PLASTIC CHANGES PRESENT ON THE PATELLAR BUTTON, BUT THE PATELLA SEEMED PERHAPS TO BE SLIGHTLY MALTRACKING. A NEW PATELLAR CUT WAS MADE, TAKING UP A BIT MORE MEDIAL BONE AND THEN MEDIALIZED A SMALLER PATELLA BUTTON TO 32MM. THE TRIAL BUTTON WAS PLACED AND THEN PLACED A TRIAL 9MM INSERT AND CHECKED STABILITY. THE KNEE WAS PERHAPS JUST SLIGHTLY SHY OF FULL EXTENSION AND A BIT TIGHT LATERALLY. LATERAL SCAR TISSUE WAS FREED UP GETTING A MORE SATISFACTORY EXTENSION ENDPOINT AND ALSO A BIT MORE STABILITY TO THE MEDIAL SIDE. THERE WERE NO COMPLIC

  Patient problems: Insufficient Information; Scar Tissue; Synovitis

  MAUDE report 20030152 ↗
• InjuryJul 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 60 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED 5 YEARS 6 MONTHS POST OP. INSERT AND PATELLA REVISED DUE TO WEAR ON BOTH. PATIENT'S LINER AND PATELLA WERE REVISED. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISCARDED AT HOSPITAL.

  Patient problems: Pain

  MAUDE report 19680659 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Swelling/ Edema

  MAUDE report 19288679 ↗
• InjuryJan 17, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST INITIAL LEFT TKA, THE 73 Y/O FEMALE PATIENT WAS REVISED DUE TO LOOSENING, OSTEOLYSIS AND POLY WEAR. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information; Osteolysis

  MAUDE report 18531390 ↗
• InjuryNov 9, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: 1. FAILED RIGHT TOTAL KNEE ARTHROPLASTY 2. GROSS POLYETHYLENE FAILURE 3. EXTENSIVE OSTEOLYSIS OF TIBIA AND FEMUR ON THE RIGHT. FINDINGS: EXTENSIVE SYNOVITIS. POLYETHYLENE FRACTURE AND FAILURE WITH DELAMINATED POLYETHYLENE THROUGHOUT THE KNEE. AORI TYPE 3 DEFECT OF THE TIBIA AND AORI 2 DEFECTS OF POSTERIOR FEMUR CONDYLES BILATERALLY. POLYETHYLENE HAD GROSSLY FAILED THERE WAS EVIDENCE OF POLYETHYLENE FAILURE WITH DELAMINATED PIECES OF POLYETHYLENE THROUGHOUT THE KNEE. THERE IS ALSO EVIDENCE OF OBVIOUS 6 BONE LOSS OF THE DISTAL FEMUR AS WELL AS THE PROXIMAL TIBIA. A FULL SYNOVECTOMY WAS PERFORMED THE SUPRAPATELLAR POUCH AS WELL AS THE MEDIAL AND LATERAL GUTTERS FOR BUT IMPROVED EXPOSURE. A QUADRICEPS SNIP WAS PERFORMED FROM PROVE EXPOSURE AS

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

  MAUDE report 18100716 ↗
• InjuryApr 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION-THE PATIENT WAS REVISED TO NON EXACTECH DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2023-POSTOPERATIVE DIAGNOSIS: LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE AND RESULTANT OSTEOLYSIS. REVISED BOTH COMPONENTS, WITH ASSOCIATED SYNOVECTOMY. INDICATIONS- PATIENT PRESENTED WITH PAIN AND EFFUSIONS. X-RAY AND CT SCAN REVEALED SOME OSTEOLYSIS. ESR AND CRP WERE NEGATIVE FOR INFECTION. REVISION FOR OSTEOLYSIS FROM POLYETHYLENE FAILURE. PROCEDURE: LARGE EFFUSION WITH HYPERTROPHIC SYNOVIUM. NO METALLOSIS, NO PURULENCE WITHIN THE JOINT. THE POLYETHYLENE SHOWED COMPLETED DESTRUCTION OF THE POSTERIOR LIP AND PITTING AND DELAMINATION THROUGHOUT THE PROSTHETIC. TIBIAL TRAY AND FEMORAL COMPONENTS WERE REMOVED WITH ALL ASSOCIATED CEMENT. THE PATELLA POLYETHYLENE WAS INSPECTED, IT APPEARED PRESERVED, SO IT WAS LEFT IN SITU. NEW DEVICES WERE TRIALED AND THEN IMPLANTED. THE PATIENT WAS AWAKENED, TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION, NO COMPLICATIONS THROUGHOUT CASE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Swelling/ Edema

  MAUDE report 16838800 ↗
• InjurySep 7, 2022Fracture; Naturally Worn; Insufficient Device Problem Information; Fracture; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT HAD A POLY SWAP AND WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION OR MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 15370303 ↗
• InjuryJun 15, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.3 YEARS POST INITIAL TKA, THE 66 Y/O FEMALE PATIENT HAD A REVISION TO REPLACE A SLOPE + INSERT DUE TO EXCESSIVE WEAR. THE 9MM SLOPE+ INSERT WAS REPLACED WITH A 13MM CRC INSERT. THERE WAS NO BREAKAGE OF A DEVICE. THERE WAS NO REPORT OF SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS DEVICE IS STILL AT HOSPITAL AND IT HAS TO GO THROUGH RISK MANAGEMENT.

  Patient problems: Failure of Implant

  MAUDE report 14691495 ↗
• InjurySep 28, 2021Naturally Worn; Naturally Worn

  AS REPORTED, PATIENT REASON FOR A BILATERAL REVISION WAS INCREASE POLY WEAR. BOTH 2.5 9MM POLY INSERTS FOR RIGHT AND LEFT KNEE WERE REPLACED WITH BILATERAL 2.5MM 13MM CRC INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12540090 ↗
• InjurySep 28, 2021Naturally Worn; Naturally Worn

  AS REPORTED, PATIENT REASON FOR A BILATERAL REVISION WAS INCREASE POLY WEAR. BOTH 2.5 9MM POLY INSERTS FOR RIGHT AND LEFT KNEE WERE REPLACED WITH BILATERAL 2.5MM 13MM CRC INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12540060 ↗

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