Optetrak Logic 02-012-48-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862174390), received between May 15, 2022 and Oct 11, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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.

• InjuryOct 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 74 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, INSTABILITY, EFFUSION, ANTALGIC GAIT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Pain

  MAUDE report 20430625 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BONE LOSS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 20174019 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SWELLING, AND INSTABILITY, TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20145150 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A REVISION OF HER KNEE 8 YEARS POST OP. SURGEON REVISED THIS PATIENT DUE TO PAIN AND JOINT EFFUSION. SOME SIGNIFICANT WEAR WAS NOTED. NO ISSUES WITH SURGERY. IMAGE RECEIVED. EXPLANTS NOT AVAILABLE. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 19279498 ↗
• InjuryNov 28, 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)2016. 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, (B)(4), AND PENDING IN THE (B)(6). 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: Insufficient Information

  MAUDE report 18216068 ↗
• InjuryJun 29, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2016. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. 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: Insufficient Information

  MAUDE report 17224172 ↗
• InjuryJun 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 60 Y/O PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023 DUE TO PAIN. 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) 2023: DIAGNOSIS: FAILED LEFT KNEE ARTHROPLASTY THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND REMOVED. AT THIS TIME, THE TIBIAL POLYETHYLENE WAS NOTED TO BE BROKEN AND WAS REMOVED. THE TIBIA WAS GROSSLY LOOSE AND REMOVED. THE PATELLA WAS WORN AND REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17090174 ↗
• InjuryNov 29, 2022Fracture; Naturally Worn; Insufficient Device Problem Information; Fracture; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2012. THE PATIENT WAS REVISED ON (B)(6) 2022.

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

  MAUDE report 15877669 ↗
• InjuryMay 15, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL TKA, THE FEMALE PATIENT RETURNED TO THE CLINIC COMPLAINING OF PAIN. A MRI SHOWED SYNOVITIS AND X-RAY SHOWED ASYMMETRIC WEAR. A REVISION WAS PERFORMED AND THE COMPONENTS WERE SECURE WITH NO SIGNS OF LOOSENING. THE KNEE WAS WASHED OUT AND A NEW 12 MM CRC INSERT WAS IMPLANTED. THE KNEE WAS STABLE WITH GOOD RANGE OF MOTION (ROM). SURGEON STATED THAT THE ORIGINAL INSERT WAS BAD WITH SIGNIFICANT DAMAGE TO ARTICULATE SURFACE. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. PHOTO RECEIVED. THE EXPLANT HAS NOT BEEN RELEASED FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14403931 ↗

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