Optetrak Logic 02-012-44-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862173546), received between Aug 7, 2020 and Oct 8, 2024 — classified as 9 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.

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 8, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MECHANICAL FAILURE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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: Failure of Implant; Pain

  MAUDE report 20402312 ↗
• InjuryFeb 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18758343 ↗
• InjuryMay 1, 2023Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO PROFOUND SWELLING. 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: (B)(6) 2023/ K MCGUINNESS RECEIVED VIA LEGAL 11 APR 2023. DIAGNOSIS: FAILED LEFT KNEE SECONDARY TO WEAR OF THE BEARING SURFACE. THERE WAS A VERY LARGE SYNOVIAL EFFUSION THAT CONSISTED PRIMARILY OF MONOCYTES AND MACROPHAGES. NO EVIDENCE OF LOOSENING OF THE PATIENT'S COMPONENTS ON PREOPERATIVE X-RAYS. DURING SURGERY THERE WAS VERY EXTENSIVE SYNOVIAL EXPANSION WITH FOREIGN BODY-TYPE REACTION. NO SIGN OF OSTEOLYSIS BUT THE TIBIAL POLYETHYLENE INSERT SHOWED SEVERE WEARING AND DELAMINATION. NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 16843531 ↗
• InjuryJan 4, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY THE USER FACILITY: WHITE/CLOUDY RESIDUE APPEARED TO BE FLOATING IN THE TUBING. NO INJURY REPORTED.

  Patient problems: Cyst(s); Failure of Implant; Inflammation; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16095630 ↗
• InjuryJun 9, 2022Material Fragmentation; Unstable; Naturally Worn; Insufficient Device Problem Information; Material Fragmentation; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2020, PATIENT UNDERWENT A TKA ON HER RIGHT KNEE AND WAS IMPLANTED WITH AN OPTETRAK TKA SYSTEM. PATIENT'S OPTETRAK TKA SYSTEM SUBSEQUENTLY FAILED IN (B)(6) 2022-LESS THAN TWO (2) YEARS AFTER IT WAS INITIALLY IMPLANTED. AS A RESULT, PATIENT REQUIRED AN ADDITIONAL SURGERY TO REMOVE AND REPLACE IT WITH ANOTHER JOINT REPLACEMENT SYSTEM. BECAUSE PATIENT REQUIRED AN ADDITIONAL REVISION SURGERY, PATIENT HAS SUFFERED SIGNIFICANT AND CONTINUING PERSONAL INJURIES, IS LIMITED IN HER ACTIVITIES OF DAILY LIVING, REQUIRES ADDITIONAL PHYSICAL THERAPY, AND HAS INCURRED SUBSTANTIAL MEDICAL BILLS AND EXPENSES. AS A DIRECT, PROXIMATE AND RESULT, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER SIGNIFICANT, PERMANENT, AND CONTINUING PERSONAL INJURIES, AS DESCRIBED HEREIN.

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

  MAUDE report 14645221 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 10 MONTHS POST RIGHT SIDE TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13415524 ↗
• InjuryJan 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YEARS POST INITIAL RIGHT TKA IMPLANT, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13366906 ↗
• InjuryAug 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2012, A (B)(6) Y/O, FEMALE PATIENT WITH A BMI OF 36.9, UNDERWENT IMPLANTATION OF A INSERT TIBIA LOGIC PSC 2.5 15M. ON (B)(6) 2019, APPROXIMATELY 89 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 10399829 ↗
• InjuryAug 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2015, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 31.6, UNDERWENT IMPLANTATION OF A INSERT TIB 2.5 15MM KNEE POSTSTAB CNSTR. ON (B)(6) 2019, APPROXIMATELY 49 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 10382053 ↗