Optetrak Logic 02-012-49-5011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862174628), received between Nov 10, 2021 and Sep 19, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint effusion; Pain; Synovitis

  MAUDE report 20258090 ↗
• InjuryJun 11, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE WITH DR. SCOTT DUNITZ, M.D. IN TULSA, OK TO ADDRESS WORSENING PAIN, SWELLING, STIFFNESS, MOTION RESTRICTION, DIFFICULTY WITH AMBULATION, AND DIFFICULTY PERFORMING SIMPLE ACTIVITIES OF DAILY LIVING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Implant Pain; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19510731 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SUFFERING, PHYSICAL INJURY AND BODILY IMPAIRMENT, HARM, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Failure of Implant; Implant Pain

  MAUDE report 19306133 ↗
• InjuryJul 31, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL LEFT TKA, THE 54 Y/O MALE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR LEFT TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA FOR POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY WHERE HE UNDERWENT A LEFT TKA TIBIAL POLY IMPLANT SWAP. THE POLY WAS BROKEN IN PIECES POSTERIORLY. THE PATIENT WAS REVISED TO A TRULIANT CRC TIBIAL INSERT SZ 5, 12MM. THERE WAS NO SURGICAL DELAY/PROLONGATION. THE PATIENT LEFT THE OPERATING ROOM (OR) STABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT WAS SENT TO THE LAB AND LEGAL AT THE FACILITY.

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

  MAUDE report 17424049 ↗
• InjuryFeb 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2017. THE PATIENT PRESENTED TO THE CLINIC WITH INCREASINGLY WORSENING KNEE PAIN AND SWELLING AND WAS REVISED ON (B)(6) 2023 AS A RESULT OF ATYPICAL RAPID POLYETHYLENE WEAR. THE PATIENT DENIED ANY SYSTEMIC SYMPTOMS THAT WOULD SUGGEST A SEPTIC KNEE. NO INTRAOPERATIVE SIGNS OF INFECTION, NO PURULENT DRAINAGE NOTED ON SURGICAL EXPOSURE. 2/2/ WOUND CULTURES WERE NEGATIVE. PIECES OF POLYETHYLENE DEBRIS COULD BE VISUALIZED WITHIN THE KNEE. EXTENSIVE REACTIVE SYNOVITIS ALSO PRESENT. NO RELEVANT COMORBIDITIES WOULD HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Swelling/ Edema; Synovitis

  MAUDE report 16293094 ↗
• InjuryMay 6, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THIRTEEN YEARS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT HAD A REVISION DUE TO INCREASE WEAR OF THE POLYETHYLENE INSERT. THERE WAS NO BREAKAGE OF THE DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14308082 ↗
• InjuryNov 10, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THIS MALE PATIENT'S KNEE WAS REVISED DUE TO POLY WEAR. FAILURE TO BALANCE FLEXION GAP. POLY IS AGED GREATER THAN 5 YEARS. IN ADDITION, TIBIAL CUT IS IN SIGNIFICANT VARUS IN THIS CASE, AND IS A CAUSE OF FAILURE.

  Patient problems: Failure of Implant

  MAUDE report 12788320 ↗

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