Optetrak Logic 02-012-49-5013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862174635), received between Nov 10, 2021 and May 17, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19346536 ↗
• InjuryJan 16, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE 67 Y/O PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY INSERT SWAP AND PATELLA IMPLANT SWAP. IT WAS NOTED THAT THE PATIENT HAD EXTENSIVE SYNOVITIS DUE TO POLY WEAR DEBRIS THAT REQUIRED A SYNOVECTOMY. BONE LOSS BEHIND THE LATERAL POSTERIOR/DISTAL CONDYLE REQUIRED BONE GRAFT SUBSTITUTE. PATIENT WAS REVISED TO REVISED TRULIANT CRC TIBIAL INSERT SZ 5 17MM AND OPTETRAK 3 PEG PATELLA 35MM. THE PATIENT LEFT THE OR STABLE. ALSO, THE INITIAL TIBIAL POLY INSERT OPENED FOR REPLACEMENT (17MM CRC) HAD DIFFICULTY INSERTING AND LOCKING PROPERLY. THIS IMPLANT WAS REMOVED AND A NEW 17MM CRC POLY WAS OPENED THAT DID INSERT AND LOCK APPROPRIATELY. THERE WAS NO BREAKAGE OF DEVICE OF 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 THE IMPLA

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

  MAUDE report 18522267 ↗
• InjuryNov 30, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL TKA, THE 72 Y/O MALE PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A FULL KNEE IMPLANT REMOVAL AND REVISED TO COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 30-45 MINUTES SURGICAL DELAY/PROLONGATION. THERE WAS NO ADVERSE EVENTS AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 18241079 ↗
• InjuryJul 17, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE 59 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 7 YEARS AND 2 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: FAILED RIGHT KNEE ARTHROPLASTY DUE TO POLYETHYLENE WEAR AND FLEXION INSTABILITY, FEMORAL COMPONENT FOUND TO BE THE DEBONDED FROM THE CEMENT. "COPIOUS STRAW-COLORED SYNOVIAL FLUID WAS OBTAINED. I THEN SENT SYNOVIAL SPECIMENS FOR CULTURE AS WELL AS FROZEN PATHOLOGY. A GENEROUS MEDIAL PEEL WAS PERFORMED TO ASSIST WITH EXPOSURE. A PARTIAL SYNOVECTOMY WAS PERFORMED TO REESTABLISH THE MEDIAL AND LATERAL GUTTERS. NEXT, THE POLYETHYLENE WAS REMOVED WITH AN OSTEOTOME. THERE WAS NO GROSS EVIDENCE OF POLYETHYLENE WEAR. THE FEMUR WAS THEN EASILY ABLE TO BE DISIMPACTED. THE IMPLANT WAS FOUND TO BE COMPLETELY DE BONDED FROM THE UNDERLYING CEMENT. THERE IS NO CEMENT ATTACHED TO THE FEMORAL COMPONENT. THE REMAINING CEMENT WAS REMOVED PIECEMEAL WIT

  Patient problems: Failure of Implant; Implant Pain; Joint effusion

  MAUDE report 17334502 ↗
• InjuryNov 10, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THIS MALE PATIENT'S LEFT KNEE WAS REVISED DUE TO POLY WEAR. FAILURE TO BALANCE FLEXION GAP. POLY IS AGED GREATER THAN 4 YEARS. TIBIAL CUT IS IN SIGNIFICANT VARUS. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12788530 ↗

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