Optetrak Logic 02-010-01-0225Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10885862001139), received between Oct 18, 2019 and Nov 21, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (19 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED FEMORAL KNEE DEBONDING/LOOSENING AND BROKEN POLYETHYLENE LINER. AS A RESULT, APPROXIMATELY 10 YEARS AND 7 MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23623792 ↗
• InjuryFeb 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A FEMORAL FRACTURE ADJACENT TO THE TOTAL KNEE FEMORAL IMPLANT. THE POSTERIOR STABILIZED INSERT WAS WORN MORE THAN EXPECTED AND LEFT FEMORAL COMPONENT WAS FOUND TO BE LOOSE. THE PATELLA COMPONENT WAS ALSO LOOSE. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT AND FEMORAL FRACTURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Cyst(s)

  MAUDE report 21469024 ↗
• InjuryJan 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DEPARTMENT 64 Y/O FEMALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 7 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. PATIENT EXPERIENCED PROTHESIS WEAR, LOOSENING, OSTEOLYSIS AND IMPLANT PAIN. POST-OP DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO OSTEOLYSIS. ASEPTIC LOOSENING FEMORAL COMPONENT LEFT TOTAL KNEE. LARGE CORTICAL OSTEOLYTIC DEFECT NONCONTAINED ANTERIOR MEDIAL TIBIA. FOUR LARGE AREA OF OSTEOLYSIS IN THE LATERAL DISTAL FEMUR, CONTAINED DEFECT. FINDINGS: LOOSE FEMORAL COMPONENT WITH DE BONDING FROM THE IMPLANT BETWEEN THE IMPLANT AND THE CEMENT MANTLE NONCONTAINED ANTERIOR MEDIAL TIBIAL DEFECT SECONDARY TO OSTEOLYSIS SEVERE POLYETHYLENE WEAR FROM THE MEDIAL SIDE OF THE POLYETHYLENE TRAY, LARGE LYTIC DEFECT IN THE ANTERIOR DISTAL FEMUR LATERALLY THIS WAS A CONTAINED DEFECT SEVERE THINNING OF THE LATERAL FEMORAL CONDYLE. THE PATIENT TOLERATED PROCEDURE WELL AND 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 ADD

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 21263323 ↗
• InjuryJan 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 100 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21079380 ↗
• InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, OSTEOLYSIS, SYNOVITIS, 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 21048850 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, FAILURE OF IMPLANT, OSTEOLYSIS, PAIN, AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21026890 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 510K: K093360 RECALL: Z-0021-2022.

  Patient problems: Synovitis

  MAUDE report 21025818 ↗
• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 126 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, OSTEOLYSIS WITH LOOSENING OF HER LEFT TOTAL KNEE REPLACEMENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND NOTED OSTEOLYSIS, THE POLYETHYLENE INSERT WITH OXIDATION AND WEAR/BREAKAGE AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. PATELLAR COMPONENT WAS INSPECTED, IT WAS WELL FIXED AND WELL POSITIONED WITHOUT ANY SIGNIFICANT WEAR AND THEREFORE WAS RETAINED. THE PATIENT WAS REVISED TO A COMPETITOR'S COMPONENTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 20842936 ↗
• InjuryNov 27, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR SIGNIFICANT PAIN, SWELLING, DEPRESSION, DIFFICULTY SLEEPING, SCARRING, SIGNIFICANT WEIGHT LOSS, INABILITY TO STAND/WALK FOR EXTENDED PERIODS OR LENGTHS, AND REDUCED MOBILITY. DURING PLAINTIFF¿S REVISION SURGERY, SURGEONS NOTED NUMEROUS OBVIOUS BONY DEFECTS ON THE FEMUR AND TIBIA CAUSED BY THE DEFECTIVE KNEE SYSTEM HAVING BEEN IMPLANTED IN PLAINTIFF. 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: Discomfort; Inflammation; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20797771 ↗
• InjuryNov 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, LACK OF MOBILITY, SYNOVITIS, BONE LOSS ON FEMUR AND TIBIA, GROSSLY LOOSE FEMUR. 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: Ambulation or Postural Difficulties; Implant Pain; Osteolysis; Synovitis

  MAUDE report 20724018 ↗
• InjuryNov 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 74 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR LOOSENING OF TOTAL KNEE REPLACEMENT, INFECTION, PAIN, FEMORAL LOOSENING, TIBIA AND FEMUR CYSTS, INFLAMMATION AND SWELLING, AND TIBIAL BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Inflammation; Medical device site infection; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20697013 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LEFT KNEE PAIN; OSTEOLYSIS, LOOSENING OF FEMUR AND TIBIA, POLYETHYLENE WEAR ON THE TIBIAL INSERT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 20224033 ↗
• InjuryAug 23, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 78 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, JOINT LAXITY, PITTING OF THE TIBIAL INSERT, POLYETHYLENE WEAR OF THE PATELLAR COMPONENT, OSTEOLYSIS OF THE TIBIA AND FEMUR, LOOSE FEMORAL COMPONENT, AND LIMITED RANGE OF MOTION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis

  MAUDE report 20047640 ↗
• InjuryJun 6, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 122 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BONE LOSS, PATELLAR COMPONENT WEAR, PAIN, SWELLING, STIFFNESS, TISSUE DAMAGE, INSTABILITY, OSTEOLYSIS, FEMORAL LOOSENING, AND SYNOVITIS. 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; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19476386 ↗
• InjuryJun 21, 2023Loosening 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 LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS, 5 MONTHS LATER WAS REVISED ON (B)(6) 2022. REVISION OPERATIVE REPORT OF (B)(6) 2022-FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC PATELLAR AND FEMORAL LOOSENING. REVISED TO COMPETITOR¿S DEVICES. PROCEDURE: A COMPLETE SYNOVECTOMY WAS PERFORMED. THE POLYETHYLENE WAS REMOVED, THERE WAS MINIMAL WEAR. THE PATELLA COMPONENT WAS GROSSLY LOOSE, AND IT APPEARED THERE WAS AN OLD PATELLA FRACTURE WITH LARGE INFERIOR FRAGMENT FIBROUSLY UNITED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE, THERE WAS MODERATE BONE RESORPTION AND NECROSIS IN THE MEDIAL FEMORAL CONDYLE. THE TIBIAL WAS LOOSELY AFFIXED AND REMOVED WITHOUT DIFFICULTY. STERILE DRESSINGS WERE APPLIED, AND THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. NO COMPLICATIONS. HOSPITAL CARE: ADMITTED (B)(6) 2022, DISCHARGED (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.

  Patient problems: Bone Fracture(s); Failure of Implant; Necrosis; Synovitis

  MAUDE report 17170959 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA CLINICAL STUDY, THE 79 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT KNEE SURGERY ON (B)(6)2021. THE PATIENT PRESENTED ON (B)(6)2021 WITH INTENSE KNEE PAIN AND RECEIVED GENICULATE NERVE BLOCK ON (B)(6)2021 AND (B)(6)2022. OUTCOME: CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17014882 ↗
• InjuryJan 25, 2023Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA AN EXACTECH CLINICAL KNEE REPLACEMENT STUDY, THAT A 68 YO FEMALE, INITIAL IMPLANT DATE, (B)(6) 2014, WAS REVISED ON (B)(6) 2017, APPROXIMATELY 3 YEARS 6 MONTHS POST THE INITIAL PROCEDURE DUE TO ASEPTIC FEMORAL LOOSENING. THE FEMORAL COMPONENT AND THE TIBIAL INSERT WERE REVISED. THE STUDY INDICATES THE EVENT WAS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE EVENT REQUIRED INPATIENT HOSPITALIZATION. THE OUTCOME INDICATES RESOLVED ON (B)(6) 2018. NO DEVICE RETURNS ANTICIPATED DUE TO STUDY GUIDELINES. NO FURTHER INFORMATION.

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

  MAUDE report 16244089 ↗
• InjuryMay 6, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT TKA, THE (B)(6) FEMALE PATIENT EXPERIENCED LOOSING OF THE FEMUR DUE TO FEMORAL BONE LOSS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL PROLONGATION. PATIENT WAS REVISED TO A COMPETITOR'S DEVICE AS SURGEON FELT PATIENT WAS A UNDERLINE NICKEL ALLERGY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS/PHOTOS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Foreign Body Reaction; Inadequate Osseointegration; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 14307791 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL TKA, THIS PATIENT VISITED HIS SURGEON AND IS PENDING A REVISION DUE TO OSTEOLYSIS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 13482983 ↗
• InjuryFeb 17, 2021Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE (B)(6) Y/O MALE PATIENT¿S FEMUR WAS REVISED DUE TO LOOSENING OF THE LEFT KNEE PROSTHESIS. THE INSERT WAS REMOVED, AND THE FEMUR WAS PULLED OFF. THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS. THE TIBIA WAS WELL FIXED. THE PATIENT RECEIVED A LOGIC CC FEMORAL PROSTHESIS AND A NEW INSERT. THE PATIENT REVIVED A SIZE 2 LEFT LOGIC CC FEMUR WITH A SPLINED PRESS FIT STEM AND NEW INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN.

  Patient problems: Failure of Implant

  MAUDE report 11338425 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Post Operative Wound Infection

  MAUDE report 10833469 ↗
• InjuryOct 18, 2019Defective Device; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INITIAL IMPLANT DATE OF THE LEFT KNEE WAS DONE IN 2013. PATIENT HAD SUFFICIENT BONE LOSS ON THE TIBIA. AS WELL AS, DISTAL/POSTERIOR OF THE FEMUR. CAUSING LOSING OF THE COMPONENTS. ALSO, THERE WAS A SIGNIFICANT PITTING OF THE 2.5/13MM INSERT. THE SURGEON REVISED EVERYTHING AS WELL AS USED A TIBIA CONE. OSSLIX WAS USED TO FILL IN THE TIBIA DEFECT. PATIENT WAS ALERT AND WELL WHEN LEAVING THE OPERATING ROOM.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9208783 ↗

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-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-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