Optetrak Logic 02-010-01-0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885862001221), received between Nov 9, 2020 and Feb 25, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (16 reports).

3 other recalls cover devices cleared under the same FDA submission (K033883); 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL LEFT TKA, THIS 52 Y/O FEMALE PATIENT WAS REVISED DUE TO LOOSENING AND POLY WEAR. ALL COMPONENTS WERE REVISED TO TKR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 21462610 ↗
• InjuryFeb 18, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 31 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, AND POLYETHYLENE DEBRIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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; Synovitis

  MAUDE report 21403481 ↗
• InjuryJan 14, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, SWELLING, SYNOVIAL CYST AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE REPORT DIAGNOSIS WAS FAILED RIGHT TOTAL KNEE SECONDARY TO FEMORAL COMPONENT LOOSENING. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT SYNOVIAL EFFUSION, A LARGE POSTERIOR SYNOVIAL CYST AND OSTEOLYSIS OF THE PROXIMAL FIBULA. IT IS NOTED THE EXTENSIVE SYNOVIAL EXPANSION WAS SECONDARY TO FOREIGN BODY REACTION AND THE FEMORAL COMPONENT LOOSENING. THERE WAS NO EVIDENCE OF INFECTION. THE TIBIAL COMPONENT WAS WELL FIXED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Joint effusion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 21147173 ↗
• InjuryDec 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 115 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, FRACTURE, PROTHESIS WEAR, SYNOVITIS, OSTEOLYSIS, AND FAILURE OF IMPLANT. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 20883098 ↗
• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT. APPROXIMATELY 91 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION. PATIENT EXPERIENCED FAILED RIGHT TOTAL KNEE WITH LOOSE FEMORAL COMPONENT, OSTEOLYSIS AND SYNOVITIS. AFTER REVISION, THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. 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: Osteolysis; Synovitis

  MAUDE report 20848498 ↗
• InjuryNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 102 MONTHS AFTER INITIAL IMPLANT. FAILED RIGHT TOTAL KNEE POLYETHYLENE PREMATURE WEAR AND FAILED LOOSE FEMORAL COMPONENT DUE TO OSTEOLYSIS FROM POLY WEAR. 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: Osteolysis

  MAUDE report 20786235 ↗
• InjuryNov 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4)). PATIENT ID: (B)(6) + RIGHT KNEE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL DEBONDING AND SEVERE PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT AND FEMORAL DEBONDING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL: (B)(6). 510K: (B)(6). UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: YES. CONCOMITANT DEVICES: 02-012-35-2511 - LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM 3716210, 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T SN: (B)(6) - ADVANCED PATELLA 29M 3 PEG IMPLANT SN: (B)(6) - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE SN: (B)(6).

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 20676132 ↗
• InjuryAug 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 104 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS. INITIAL SURGERY AND 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 20067878 ↗
• InjuryFeb 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT WAS BROUGHT BACK FOR RIGHT KNEE PAIN. THE POLY INSERT WAS REMOVED WITH THE HELP OF AN OSTEOTOME. THE TIBIA WAS CHECKED AND FOUND TO BE LOOSE AND REMOVED. THE FEMUR WAS CHECKED AND FOUND TO BE LOOSE AND REMOVED. THE PATIENT WAS REVISED TO A KNEE SIZE 2 TRULIANT LOGIC CC FEMUR, PRESS FIT STEMS, SIZE 1 TIBIA AND A 17 CC INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO PATIENT REQUESTED IMPLANTS.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 18735661 ↗
• InjuryDec 29, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. 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. UNABLE TO LOCATE PATIENT IN EBI. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Osteolysis; Synovitis

  MAUDE report 18417562 ↗
• InjuryJun 28, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  UPDATE -REVISION OPERATIVE REPORT OF (B)(6) 2023 POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT FEMORAL COMPONENT/PREMATURE WEAR OF RIGHT POLY LINER. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO EVIDENCE OF GROSS PURULENCE OR TISSUE NECROSIS, VISUAL INSPECTION REVEALED SEVERE SYNOVITIC CHANGES CONSISTENT WITH POLYETHENE WEAR DISEASE. THE FEMORAL COMPONENT WAS GROSSLY LOOSE. PATELLAR COMPONENT- WELL-FIXED WITHOUT EVIDENCE OF MACROSCOPIC WEAR. POLY DEMONSTRATED ADVANCED ASYMMETRIC WEAR INVOLVING PRIMARILY THE MEDIAL PORTION OF THE COMPONENT WITH EXTENSIVE PITTING AND DELAMINATION. THE TIBIAL COMPONENT DEMONSTRATED MILD OSTEOLYSIS SURROUNDING THE OUTER MARGINS OF THE IMPLANT; IT WAS FOUND TO BE WELL FIXED. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO HER HOSPITAL BED AND TAKEN TO RECOVERY IN STABLE CONDITION. NO ADDITIONAL INFORMATION.

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

  MAUDE report 17216018 ↗
• InjuryMay 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 65 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT COMPLAINED OF PAIN. A LOOSE FEMUR WAS INDICATED. THEY WERE REVISED TO A COMPETITOR¿S DEVICES. THERE WAS NO SURGICAL DELAYS OR DEVICE BREAKAGES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURN ANTICIPATED DUE TO THE HOSPITAL WILL NOT RELEASE THE IMPLANTS. PHOTOS OF THE AFFECTED PRODUCT AND X-RAY IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 16899735 ↗
• InjuryMar 31, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP THE INITIAL RIGHT TKA, THIS 72 Y/O FEMALE PATIENT WAS REVISED DUE A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE AND XRAYS ATTACHED. DEVICES ARE NOT RETURNING - DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 16655203 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED VIA EXPERIENCE REPORT- IT WAS REPORTED THAT A 65 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT COMPLAINED OF PAIN. A LOOSE FEMUR WAS INDICATED. THEY WERE REVISED TO A COMPETITOR¿S DEVICES. THERE WAS NO SURGICAL DELAYS OR DEVICE BREAKAGES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURN ANTICIPATED DUE TO THE HOSPITAL WILL NOT RELEASE THE IMPLANTS. PHOTOS OF THE AFFECTED PRODUCT AND X-RAY IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 16518677 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ELEVEN YEARS POST INITIAL RIGHT TKA, THIS (B)(6) FEMALE PATIENT PRESENTED WITH INSTABILITY IN THE RIGHT KNEE. SURGEON REVISED THE FEMORAL COMPONENT TO A CONSTRAINED SIZE 2 RIGHT CONSTRAINED FEMUR WITH A 2/13MM TRANSITIONAL POLY. THERE WAS LITTLE OSTEOLYSIS. THERE WAS NO SURGICAL DELAY/PROLONGATION REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14075010 ↗
• InjuryMar 31, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT POLY WAS BEING REVISED DUE TO LOOSE FEMUR. PATIENT HAD A LOOSE FEMUR AND SLIGHTLY WORN POLY. PATIENT WAS REVISED TO (B)(6). THERE WAS NO BREAKAGE OF A DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 13967587 ↗
• InjuryMar 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 6.5 YEARS POST INITIAL RIGHT TKA, THE HUSBAND OF THE (B)(6) FEMALE PATIENT REPORTED THAT THE PATIENT¿S RIGHT KNEE WAS INITIALLY IMPLANTED AND PATIENT SEEMED TO RECOVER WELL FROM THE PROCEDURE, EXCEPT THAT THE SCAR WAS LARGE. THE PATIENT STARTED EXPERIENCING PAIN AND SWELLING FOR ¿AWHILE¿ BEFORE SHE WAS RETURNED FOR A REVISION WITH COMPETITOR¿S DEVICES. IT WAS NOTICED DURING THE REVISION THAT THE PATIENT¿S FEMORAL COMPONENT WAS LOOSENING. THE WOUND WAS CULTURED FOR INFECTION AND CAME BACK NEGATIVE. THERE WAS NO BREAKAGE OF DEVICE AND NO SURGICAL DELAY/PROLONGATION. THE PATIENT EXPERIENCED A LONG, SEVERELY PAINFUL RECOVERY AND STILL IS NOT AMBULATORY, SHE USES A WHEELCHAIR OR A WALKER AND ¿SEVERE SCARRING¿. ¿SHE IS TERRIFIED OF THE THOUGHT OF HAVING ANOTHER SURGERY.¿ SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13795945 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR YEARS POST LEFT SIDE TKA, THIS (B)(6) Y/O FEMALE PATIENT HAD A REVISION DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 13485365 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 37 MONTHS AFTER THE INITIAL IMPLANT FOR THIS (B)(6) Y/O FEMALE PATIENT, THE 2.5 FEMORAL COMPONENT WAS REPLACED DUE TO FRACTURE OF THE DISTAL FEMUR AND WAS REPLACED WITH A CC LOGIC. THE PATIENT'S FRACTURE OF THE DISTAL FEMUR WAS DUE TO A FALL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY HOSPITAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 11796921 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2013. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10946565 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2014, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2014. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10808445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants