Optetrak Logic 02-010-01-0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10885862001122), received between Feb 12, 2020 and Jul 28, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (20 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026

  According to the information provided, the patient underwent a left total knee replacement surgery. Approximately 12 years and 11 months later, the patient had revision surgery on the left knee. All components were removed. Per the Operative Report, the patient presented with significant mechanical loosening and instability of their left primary total knee prosthesis. This was refractory to comprehensive nonoperative management due to extensive polyethylene wear and osteolysis. Because the patient has filed a long form, it appears that they are alleging prosthesis wear, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 50058408 ↗
• InjuryJul 20, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO MECHANICAL INSTABILITY AND PARTICLE DISEASE ASSOCIATED WITH PET WEAR. THE PATIENT WAS EXPERIENCING CONSTANT PAIN. REPORTED PAIN IN RELATION TO THE TIBIA RADIATING TO THE PRE-TIBIAL REGION. FEELING OF INSTABILITY WITHOUT FALLING TO THE GROUND. INCREASINGLY REPORTS PAIN AND INSTABILITY. PHYSICAL EXAMINATION NOTED A COLD KNEE, INTACT SKIN, MARKED PAIN OVER THE TIBIAL COMPONENT AND LATERAL TIBIAL PLATEAU, MEDIAL LAXITY WITH LIGAMENTOUS ENDPOINT, AND NON-TENSE JOINT EFFUSION. RADIOGRAPHS DEMONSTRATED OSTEOLYSIS OF THE MEDIAL TIBIAL PLATEAU AND MEDIAL FEMORAL CONDYLE. CT FINDINGS NOTED CYSTIC LESIONS INVOLVING BOTH TIBIAL PLATEAUS AND THE TIBIAL KEEL WITH EVIDENCE OF POLYETHYLENE WEAR. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS INFILTRATION OF QUADRICEPS AND PATELLAR TENDONS, SYNOVIAL HYPERTROPHY WITH FOREIGN-BODY GRANULOMATOUS TISSUE, POLYETHYLENE DEBRIS WITHIN JOINT EFFUSION, WEAR AND PARTIAL FRACTURE OF THE MEDIAL POLYETHYLENE INSERT, FREE POLYETHYLENE FRAGMENTS, CONTAINED LATERAL FEMORAL CONDYLE DEFECT (AORI 2B), CONTAINED LATERAL TIBIAL PLATEAU DEFECT (AORI 2

  Patient problems: Cyst(s); Joint Laxity; Joint effusion; Metal Related Pathology; Pain

  MAUDE report 25871504 ↗
• InjuryNov 24, 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 LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 14 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION. IT WAS LATER OBSERVED THAT THE PATIENT'S FEMORAL COMPONENT HAD DEBONDED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 23632752 ↗
• InjuryNov 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 156 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT WAS EXPERIENCING PAIN AND DIFFICULTY AMBULATING. HISTORY, PHYSICAL EXAMINATION, AND IMAGING SUGGESTED ASEPTIC LOOSENING DUE TO DEFECTIVE POLYETHYLENE. THE PATIENT WISHED TO PROCEED WITH A REVISION. A SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS DISLOCATED LATERALLY. THE PATELLA WAS FOUND TO BE WELL FIXED. THE PATELLA WAS REMOVED. THE POLYETHYLENE WAS REMOVED. ATTENTION WAS THEN TURNED TO THE FEMUR. THE FEMORAL COMPONENT WAS WELL FIXED. THE FEMUR WAS REMOVED AND CEMENT WAS REMOVED FROM THE DISTAL FEMUR AND CANAL. BONY INVENTORY AFTER REMOVED OF THE FEMORAL COMPONENT REVEALED AORI TYPE 1 BONE LOSS DUE TO OSTEOLYSIS. ATTENTION WAS THEN TURNED TO THE TIBIA. THE TIBIAL COMPONENT WAS FOND TO BE WELL FIXED. THE TIBIAL COMPONENT WAS REMOVED. THE REMAINDER OF THE CEMENT WAS REMOVED. BONEY INVENTORY REVEALED AORI TYPE 1 BONE LOSS DUE TO OSTEOLYSIS. MOST OF THE BONE LOSS WAS CENTRAL-LATERAL AND ANTERIORLY INVOLVING THE ANTERIOR CORTEX. CEMENT RESTRICTORS WERE PLACED IN THE FEMUR AND TIBIA. CEMENT WAS MIXED. THE TIBIA AND FEMUR WERE IRRIGATED AND THE CANALS WERE DRIED. CEMENT WAS FIRST PLACED

  Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain; Synovitis

  MAUDE report 23546730 ↗
• InjuryJul 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, AND COMPONENT LOOSENING. 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: Implant Pain; Scar Tissue; Synovitis

  MAUDE report 22386074 ↗
• InjuryMar 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YRS POPSTOP THE INITIAL L TKA, THIS FEMALE PATIENT¿S LEFT KNEE WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS. THE INSERT WAS REMOVED, THE FEMUR AND TIBIA BOTH CHECKED AND FOUND TO BE LOOSE. PATIENT HAD SIGNIFICANT BONE LOSS AND NEEDED A DISTAL FEMORAL REPLACEMENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL DISCARDED THE DEVICES.

  Patient problems: Osteolysis

  MAUDE report 21549878 ↗
• InjuryMar 5, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 56 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, AND ASEPTIC LOOSENING OF THE FEMUR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE SURGEON PERFORMED A REVISION TOTAL KNEE REPLACEMENT OF THE TIBIAL AND FEMORAL COMPONENTS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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; Discomfort; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21527476 ↗
• InjuryMar 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND JOINT LAXITY. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING CEMENTED LEFT KNEE PROSTHESIS AND POLYETHYLENE WEAR/FAILURE. INTRAOPERATIVE FINDINGS NOTED SYNOVITIS WITH PE PARTICLES. SIGNIFICANTLY LOOSE CEMENTED PS FEMORAL COMPONENT. SUBSIDED CEMENTED TIBIAL COMPONENT. WORN PE PATELLA COMPONENT-WELL FIXED. MEDIAL CAVITARY DISTAL FEMORAL BONE LOSS WAS NOTED. NO SIGNIFICANT TIBIAL OR PATELLA BONE LOSS WAS ENCOUNTERED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 21506430 ↗
• InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 47 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, FIBROSIS, IMPLANT PAIN, OSTEOLYSIS, SWELLING AND EDEMA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 21046967 ↗
• InjuryDec 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL NOTIFICATION, THIS FEMALE PATIENT HAD BILATERAL TKAS ON (B)(6) 2018. SHE STARTED TO DEVELOP SOME DISCOMFORT IN HER LEFT KNEE AND RADIOGRAPHS OBTAINED IN (B)(6)2022 DEMONSTRATED DISSOLUTION OF THE POLYETHYLENE COMPONENT MEDIALLY, AS WELL AS FAINT OSTEOLYSIS. REVISION WAS ADVISED DUE TO SYNOVITIS AND DISCOMFORT. MORE RECENT RADIOGRAPHS DEMONSTRATED MORE AGGRESSIVE OSTEOLYSIS WITH PROBABLE LOOSENING OF THE FEMORAL COMPONENT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6)2023. EXTENSIVE SYNOVITIS WAS NOTED. THE POLYETHYLENE INSERT WAS REMOVED AND IT WAS NOTED THAT THERE WAS EXTENSIVE WEAR MEDIALLY AND ABOUT THE POST WITH COMPLETE DELAMINATION OF THE PLASTIC. THE LOOSE FRAGMENTS OF PLASTIC WERE NOTED THROUGHOUT THE KNEE. THE FEMORAL COMPONENT WAS EASILY REMOVED AND DEBONDED COMPLETELY FROM THE UNDERLYING CEMENT. A COMPLETE DEBRIDEMENT OF THE KNEE WAS PERFORMED. (B)(6), 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883 CONCOMITANTS: (B)(6)- 02-010-01-0220 - LOGIC FEMORAL PS CEM LEFT SZ 2. (B)(6)- 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ 2F / 3T. (B)

  Patient problems: Discomfort; Osteolysis; Synovitis

  MAUDE report 21020945 ↗
• InjuryDec 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, MUSCLE WEAKNESS/ATROPHY, DISCOMFORT, SYNOVITIS, OSTEOLYSIS, IMPLANT 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. 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; Implant Pain; Muscle Weakness/Atrophy; Osteolysis; Synovitis

  MAUDE report 20881187 ↗
• InjuryDec 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE-USA: IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT CASE IS FROM THE UNITED STATES. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED.

  Patient problems: Osteolysis

  MAUDE report 20864614 ↗
• InjuryOct 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING AND PAIN, SYNOVITIS, OSTEOLYSIS, POLYETHYLENE WEAR OF THE INSERT, GROSSLY DEBONDED FEMORAL. 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; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20382737 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 13 YEARS 4 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR, RECALLED POLY AND PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND DUE TO RECALL

  Patient problems: Implant Pain; Pain

  MAUDE report 20233314 ↗
• InjurySep 13, 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 82 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION OR POSTURAL DIFFICULTIES, OSTEOLYSIS, SYNOVITIS, JOINT LAXITY AND PAIN. 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; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20218026 ↗
• InjuryAug 28, 2024Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 112 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, DESTRUCTION OF BONE, OSSEOUS RESORPTION, OSTEOLYSIS, SYNOVITIS, SWELLING, PAIN, LIMITED RANGE OF MOTION, DIFFICULTY WALKING, AND LOSS OF ENJOYMENT OF LIFE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20087546 ↗
• InjuryAug 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  12-AUG-2024 ADDITIONAL INFORMATION: AS REPORTED VIA EMAIL TO LEGAL 07-AUG -2024 (PRODUCT IDENTIFICATION LIST, IMPLANT OP REPORT AND REVISION OP REPORT ATTACHED). PRE/POST DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO STIFFNESS. OP NOTES: UPON ENTERING THE KNEE THERE WAS A LARGE AMOUNT OF CLEAR LOOKING SYNOVIAL FLUID. FLUID CULTURES WERE NOT SENT. PATELLA WAS EVERTED AND A COMPLETE SYNOVECTOMY OF THE UNDERSURFACE OF THE EXTENSOR MECHANISM AND THE ENTIRE SUPRAPATELLAR POUCH. ALL SCAR TISSUE ABOUT THE POUCH WAS REMOVED IN ENTIRETY. PATELLA FOUND TO BE WELL FIXED. PATELLA NOT REVISED. TIBIA WAS DISLOCATED FORWARD. THE POLYETHYLENE WAS EXTRACTED WITHOUT DIFFICULTY. TIBIA WAS NOTED TO BE WELL FIXED; CAREFULLY REMOVED. THERE WAS A LARGE METAPHYSEAL DEFECT AFTER THE REMOVAL OF ALL CEMENT. FOR THIS REASON, ELECTED TO USE A METAPHYSEAL CONE. ATTENTION WAS THEN DIRECTED TO THE FEMUR. FEMORAL COMPONENT FOUND TO BE WELL FIXED. THERE WAS A LARGE AMOUNT OF HYPERTROPHIC BONE AND RETAINED OSTEOPHYTES ABOUT THE DISTAL FEMUR. FEMORAL COMPONENT EXTRACTED FROM THE CEMENT MANTLE WITHOUT ANY DISRUPTION OF THE CEMENT MANTLE, NO SIGNIFICANT BONE LOSS. REVISION LEFT TKA; REPLACEMENT OF TIBIAL

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19964076 ↗
• InjuryMay 14, 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 108 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND CONFIRMED POLYETHYLENE WEAR AND LOOSE FEMORAL AND TIBIAL COMPONENTS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information; Synovitis

  MAUDE report 19315303 ↗
• InjuryDec 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 67 YO FEMALE, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2010, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 12 YEARS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. LOOSE FEMUR INDICATED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING DUE TO CHAIN OF CUSTODY. DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE IMPLANTS. NO FURTHER INFORMATION KNOWN.

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

  MAUDE report 15920916 ↗
• InjuryOct 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 11 YEARS POST OP THE INITIAL TSA, THIS 78 Y/O FEMALE PATIENT WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING, FEMORAL COMPONENT LOOSENING WITH LATERAL FEMORAL CONDYLE OSTEOLYSIS. PATIENT REVISED FEMORAL AND TIBIAL INSERT. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND UNLIKELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONSIDERED RESOLVED.

  Patient problems: Aseptic loosening; Failure of Implant; Osteolysis

  MAUDE report 15624743 ↗
• InjuryJun 14, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT TKA, THE 65 Y/O FEMALE PATIENT STARTED HAVING PAIN. SURGEON HAD REMOVED A LOOSE FEMORAL IMPLANT THAT NEED REVISED TO A SIZE 2 CONDYLAR CONSTRAINT FEMUR, ALONG WITH REPLACING THE POLY TO A 17MM CONSTRAIN LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND PHOTOS RECEIVED. THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 14684530 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FIVE YEARS POST INITIAL TKA, THIS (B)(6) PATIENT EXPERIENCED ANTERIOR KNEE PAIN. PATIENT HAD A GRADUAL ONSET LEFT ANTERIOR KNEE PAIN AND "LOCKING" ON RISING FROM A CHAIR. WAITS A MINUTE AND CAN MOBILIZE NORMALLY WITHOUT PAIN. QUADS WEAKNESS DETECTED GRADE 4+. THE EVENT IS ONGOING. THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 13624004 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST BILATERAL TKA, THIS (B)(6) FEMALE PATIENT HAD A GROSSLY LOOSE FEMORAL COMPONENT WITH SEVERE OSTEOLYSIS OF DISTAL FEMUR AND OSTEOLYSIS OF PROXIMAL TIBIAL WITH PARTIALLY LOOSE TIBIAL COMPONENT. PATIENT HAD LEFT TKA REVISION REQUIRING USE OF FEMORAL AUGMENTS AND TIBIAL CONE.

  Patient problems: Osteolysis

  MAUDE report 13483271 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY SIX YEARS POST TKA, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCED LEFT KNEE PAIN. ARTHROSCOPY AND DEBRIDEMENT WITH BIOPSY COMPLETED AS A DAY CASE.

  Patient problems: Failure of Implant

  MAUDE report 12733619 ↗
• InjurySep 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, TIBIAL AND FEMORAL COMPONENTS LOOSENED OVER TIME. PATIENT COMPLAINED OF PAIN AND DISCOMFORT. COMPONENTS WERE REMOVED AND REVISED TO TRULIANT CCK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12436296 ↗

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