Optetrak Logic 02-012-47-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862174369), received between Jul 24, 2023 and Dec 11, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2017. THE PARTY STATED THAT SHE HAS SUFFERED PAINS AFTER HER KNEE SURGERY. SHE WAS REVISED TO A DIFFERENT INSERT OF THE SAME SIZE. NO RADIOGRAPHS, OR DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION KNOWN AT THIS TIME.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20904021 ↗
• InjuryNov 18, 2024Naturally Worn; Naturally Worn

  LEGAL CASE: USA. PATIENT ID: (B)(6) + LEFT KNEE. CASE: (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE." LEGAL CASE: USA. PATIENT ID: (B)(6) + LEFT KNEE. CASE: (B)(4) IS ASSOCIATED WITH THIS CASE. DURING THE REVIEW OF CASE: (B)(4), IT WAS DISCOVERED THAT THE PATIENT UNDERWENT AN INDEX LEFT TOTAL KNEE PROCEDURE ON (B)(6) 2016. NO ALLEGATIONS HAVE BEEN MADE AGAINST THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER: (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 02-012-47-3013 - LOGIC CR TIB INSERT STD, SZ 3,13MM. SERIAL: (B)(6), 510K: K111400, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6), 02-010-03-0230 - LOGIC CR FEMORAL CEM, LEFT, SZ 3, (B)(6), 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, (B)(6), 200-02-29 - THREE PEG PATELLA 29MM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712266 ↗
• InjurySep 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 99 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: Insufficient Information

  MAUDE report 20334079 ↗
• InjurySep 26, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 47 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER: (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20309752 ↗
• InjurySep 17, 2024Naturally Worn; Naturally Worn

  LOR FORM RECEIVED IN COMPLAINT INBOX ON 06DEC2023. NO INFORMATION PROVIDED OTHER THAN PATIENT NAME.

  Patient problems: Insufficient Information

  MAUDE report 20235894 ↗
• InjuryAug 15, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH). RELATED (B)(4) RK. IT WAS REPORTED THAT APPROXIMATELY 132 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PLAINTIFF HAS SUFFERED FROM PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND INSTABILITY WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S PHYSICAL MOBILITY AND QUALITY OF LIFE. PLAINTIFF REQUIRED A LEFT TOTAL KNEE REVISION SURGERY ON (B)(6) 2023. PLAINTIFF WENT ON TO ENDURE FURTHER PAIN DURING THE RECUPERATION PERIOD AND REQUIRED PHYSICAL THERAPY. PLAINTIFF'S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN CONSEQUENTLY LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19995720 ↗
• InjuryAug 15, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH). REFER TO (B)(4) FOR LK. IT WAS REPORTED THAT APPROXIMATELY 124 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PLAINTIFF HAS SUFFERED FROM PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND INSTABILITY WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S PHYSICAL MOBILITY AND QUALITY OF LIFE. PLAINTIFF REQUIRED A RIGHT TOTAL KNEE REVISION SURGERY ON (B)(6) 2023. PLAINTIFF WENT ON TO ENDURE FURTHER PAIN DURING THE RECUPERATION PERIOD AND REQUIRED PHYSICAL THERAPY. PLAINTIFF'S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN CONSEQUENTLY LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19995463 ↗
• InjuryNov 14, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 18129176 ↗
• InjuryJul 24, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 4 YEARS AND 9 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: RIGHT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE A LARGE EFFUSION WHICH WAS NONPURULENT AND NO METALLOSIS PRESENT. WE DID SYNOVECTOMY OF SUPRAPATELLAR POUCH, MEDIAL AND LATERAL GUTTERS, AS WELL AS THE NOTCH AND THEN WE WERE ABLE TO ISOLATE THE POLYETHYLENE AND REMOVED IT FROM THE TIBIAL TRAY WITH THE OSTEOTOME. YOU CAN APPRECIATE DELAMINATION ABOUT THE MEDIAL COMPARTMENT AND TO THE LESSER DEGREE THE LATERAL SIDE. IT CERTAINLY INVOLVED WITH ABNORMAL POLYETHYLENE WEAR. THE PATIENT WAS AWOKE AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS.

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

  MAUDE report 17377972 ↗

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