Optetrak Logic 02-012-35-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862001863), received between Jun 2, 2021 and Mar 27, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (14 reports).

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

1 other recall cover devices cleared under the same FDA submission (K093360); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 82 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AND DISCOMFORT. NO REVISION OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE TIBIAL COMPONENT AND LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON PERFORMED A REVISION OF THE FEMORAL COMPONENT AND TIBIAL POLYETHYLENE EXCHANGE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Pain

  MAUDE report 21708213 ↗
• InjuryFeb 25, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 1 MONTH POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THIS CASE WAS SCHEDULED AS JUST A POLY EXCHANGE DUE TO THE RECALL. ONCE THE SURGEON DISSECTED DOWN HE REALIZED THE FEMUR WAS FALLING OFF AND THERE WAS LOTS OF OSTEOLYSIS, SO HE REVISED TO COMPETITOR'S DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21465405 ↗
• InjuryOct 10, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4) CASE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 107 MONTHS AFTER A LEFT 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Insufficient Information

  MAUDE report 20423856 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO ABNORMAL WEAR OF THE POLY. INITIAL IMPLANT DATE UNKNOWN. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20134075 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 64 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 20065318 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 YEARS, 10 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19326298 ↗
• InjurySep 25, 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)2012. FOLLOWING THESE SURGERIES, THE PATIENT BEGAN EXPERIENCING INCREASING PAIN, ¿SHIFTING OF HER KNEES,¿ AND IMPAIRED MOBILITY. RECURRENT EFFUSIONS AND INCREASING PAIN ALSO BEGAN OCCURRING. X-RAYS DEMONSTRATED EVIDENCE OF FEMORAL OSTEOLYSIS. THE PATIENT ALSO CONTINUES TO EXPERIENCE SYMPTOMS WITH HER RIGHT KNEE. THE PATIENT'S SURGEON RECOMMENDED CONTINUED MONITORING OF THE RIGHT KNEE AND POSSIBLE REVISION SURGERY. 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: Failure of Implant; Insufficient Information

  MAUDE report 17809031 ↗
• InjuryJul 20, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. THIS HAS NOT YET BEEN EXPLANTED. PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN, SWELLING AND POPPING. ON (B)(6) 2022 THE PATIENT REPORTED SWELLING AFTER DAILY ACTIVITIES. 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: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Implant Pain; Joint Laxity; Osteolysis; Pain

  MAUDE report 17361732 ↗
• InjuryJun 16, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2016. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 6 YEARS 4 MONTHS AFTER THEIR INITIAL IMPLANTATION. PATIENT CLAIMS TO HAVE SUFFERED FROM PAIN, SWELLING, LOSS OF MOTION, WEAKNESS, AND GIVING WAY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17145533 ↗
• InjuryJun 16, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEIR RIGHT KNEE WAS SUBSEQUENTLY REVISED ON (B)(6) 2020, APPROXIMATELY 8 YEARS 7 MONTHS AFTER THEIR INITIAL IMPLANTATION. THE PATIENT HAS CLAIMED INJURIES AND COMPLICATIONS INCLUDING PAIN, SWELLING, STIFFNESS, LOSS OF MOTION, WEAKNESS, AND GIVING WAY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17144250 ↗
• InjuryJun 1, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT (B)(6)2017. SHE HAD RIGHT KNEE REVISION (B)(6)2023, APPROXIMATELY 5 YEARS 10 MONTHS AFTER THEIR INITIAL IMPLANTATION. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE POLYETHYLENE DUE TO PREMATURE POLY WEAR AND POLY RECALL WITH OSTEOLYSIS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. THERE WAS FOUND TO BE A GROSSLY LOOSE FEMORAL COMPONENT WITH A LOOSE TIBIAL COMPONENT WITH MODERATE AMOUNT OF OSTEOLYSIS ON THE BACK SIDE OF EACH COMPONENT. THERE WAS NO CEMENT ADHERENT TO THE FEMORAL COMPONENT. ALL OF THE CEMENT REMAINED ON THE DISTAL FEMUR. THERE WAS A MILD AMOUNT OF OSTEOLYSIS BEHIND THE CEMENT MANTLE. THERE WAS A SEVERE AMOUNT OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE AND THERE WAS ENCAPSULATED POLYETHYLENE DEBRIS OF THE SYNOVIUM. A COMPLETE SYNOVECTOMY WAS PERFORMED. THERE WAS A WELL-FIXED PATELLAR COMPONENT. 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: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 17043561 ↗
• InjuryMay 23, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, PATIENT HAD A REVISION DUE TO PROSTHESIS HIGH WEAR RATE. THE REVISION WAS NOT RELATED TO RECALL ISSUE. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16989394 ↗
• InjuryJan 4, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP THE INITIAL LEFT TKA, THIS 99 Y/O PATIENT WAS REVISED DUE TO PAIN AND WEAR. PATIENT HAD A RECALLED IMPLANT. THE MEDIAL ASPECT OF THE JOINT SPACE SEEMED SLIGHTLY THINNER THAN THE LATERAL ASPECT INDICATING WEAR. THE FEMUR DEBONDED FROM THE CEMENT MANTLE. THE POLY SHOWED SIGNS OF DEGRADATION AND WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. DEVICES ARE NOT RETURNING, THE HOSPITAL DOES NOT ALLOW FOR THE RETURN OF EXPLANTS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16095721 ↗
• InjuryJun 2, 2021Naturally Worn; Naturally Worn

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 3.5 YEARS POST TKA, THE (B)(6) Y/O MALE PATIENT EXPERIENCED SEVERE POLY WEAR. PATENT HAS SEVERE WEAR CREATING A CONCAVED SURFACE ON THE POSTERIOR SURFACE OF THE POST. NEITHER THE FEMORAL NOR TIBIAL IMPLANTS WERE LOOSE. MEDIAL AND LATERAL TIBIAL POLY ARTICULAR SURFACES WERE SEVERELY WORN PARTICULARLY POSTERIOR LATERAL AND ANTERIOR MEDIAL. (DELAMINATION) ALSO SEVERE WEAR OF THE ANTERIOR POST. NATURAL PATELLA. NO UNUSUAL ACTIVITIES. SURGEON EXPLORED PATIENT¿S KNEE BECAUSE OF PAIN AND UNEXPLAINED EFFUSIONS. REPLACED WITH A NEW INSERT. THE EVENT IS RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE DEVICE WILL NOT RETURN DUE TO STUDY POLICY.

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

  MAUDE report 11920996 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ