Optetrak Logic 02-012-35-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10885862001726), received between Feb 4, 2020 and Jul 20, 2026 — classified as 96 injuries.

The most frequently reported specific device problem is “Naturally Worn” (75 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

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 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Crack; Unstable; Naturally 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 25871451 ↗
• InjuryJun 2, 2026Naturally Worn

  AS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, EIGHT (8) YEARS LATER, THE PATIENT COMPLAINED OF PAIN AND JOINT EFFUSION. AS A RESULT, THE PATIENT UNDERWENT A REVISION OF THE PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSES NOTES FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, FEMORAL OSTEOLYSIS, AND LOOSE FEMORAL COMPONENT. INTRAOPERATIVELY, SIGNIFICANT OSTEOLYTIC DEBRIS IN THE SYNOVIUM WAS OBSERVED. THE PATELLA WAS FOUND TO BE WELL FIXED WITH NO WEAR. THE INSERT WAS REMOVED AND FOUND TO HAVE OXIDATION AND DELAMINATION. THE TIBIA WAS SOLID, BUT THE FEMORAL COMPONENT EASILY REMOVED FROM THE CEMENT MANTLE. WHEN RESECTING THE LATERAL SIDE BENEATH THE CEMENT, THERE WAS A LARGE UNCONTAINED POSTEROLATERAL OSTEOLYTIC CYST WHICH WAS DEBRIDED BACK TO HEALTHY BONE AND THE DEFECT CORRECTED WITH CEMENT. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. RADIOGRAPH AND IMAGES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Osteolysis; Pain

  MAUDE report 25364134 ↗
• InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED APPROXIMATELY 84 MONTHS AFTER RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED PAIN AND SUBSEQUENTLY UNDERWENT A RIGHT KNEE REVISION PROCEDURE OF THE INSERT, PATELLA AND TRAY COMPONENTS. NO MEDICAL RECORDS, PICTURES OR X-RAYS WERE PROVIDED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22092137 ↗
• InjuryJan 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT STATED THEY UNDERWENT A KNEE REPLACEMENT ON THEIR LEFT KNEE AND IS ALWAYS EXPERIENCING PAIN. INFORMATION PROVIDED INDICATES THE PATIENT WAS REVISED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21261033 ↗
• InjuryJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 113 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, DETACHMENT OF DEVICE, OSTEOLYSIS, BONE FRACTURE(S), IMPLANT PAIN, DISCOMFORT, JOINT LAXITY AND SWELLING/ EDEMA. 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: Bone Fracture(s); Discomfort; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 21066653 ↗
• InjuryOct 14, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO.(B)(4) CASE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 96 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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: Insufficient Information

  MAUDE report 20440226 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) CASE-(B)(4) RK IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. FAILURE OF LEFT TOTAL KNEE REPLACEMENT SECONDARY TO SIGNIFICANT WEAR OF THE POLYETHYLENE INSERT AND PATELLA RESULTING IN SYNOVITIS AND SUBSTANTIAL OSTEOLYSIS AS WELL AS POSSIBLE ASEPTIC LOOSENING. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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: Osteolysis; Synovitis

  MAUDE report 20429395 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BILATERAL KNEE PAIN; SEVERE OSTEOLYSIS; SIGNIFICANT WEAR ON THE POLYETHYLENE INSERT, HAVING WORN THROUGH ON THE POSTERIOR MEDIAL ASPECT, INCLUDING PITTING AND DELAMINATION; DEBONDING OF FEMORAL, SIGNIFICANT BACKSIDE WEAR OF THE PATELLA. 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: Implant Pain; Osteolysis; Synovitis

  MAUDE report 20249031 ↗
• InjurySep 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BILATERAL KNEE PAIN; SEVERE OSTEOLYSIS; SIGNIFICANT WEAR ON THE POLYETHYLENE INSERT, HAVING WORN THROUGH ON THE POSTERIOR MEDIAL ASPECT, INCLUDING PITTING AND DELAMINATION; DEBONDING OF 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: Implant Pain; Osteolysis; Scar Tissue

  MAUDE report 20248975 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BILATERAL KNEE PAIN; SEVERE OSTEOLYSIS; SIGNIFICANT WEAR ON THE POLYETHYLENE INSERT, HAVING WORN THROUGH ON THE POSTERIOR MEDIAL ASPECT, INCLUDING PITTING AND DELAMINATION; DEBONDING OF 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: Implant Pain; Osteolysis; Scar Tissue

  MAUDE report 20248524 ↗
• InjurySep 16, 2024Naturally Worn; Naturally Worn

  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 20233221 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 156 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DIFFICULTY AMBULATING. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 20204893 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 143 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Pain

  MAUDE report 20138182 ↗
• InjuryAug 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 89 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20089354 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 149 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYSIS, ASEPTIC LOOSENING, SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION AND SIGNIFICANT METALLOSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Fibrosis; Joint effusion; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 20086272 ↗
• InjuryAug 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 8 MONTHS POST THE INITIAL RIGHT TKA, THE PATIENT WAS REVISED DUE TO EARLY POLY WEAR FROM THE RECALLED POLY CAUSING INSTABILITY. THE INSERT WAS EXCHANGED FROM A 2 X 9 PS TO A 2 X 9 PSC. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity

  MAUDE report 20085971 ↗
• InjuryAug 23, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 84 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 20051836 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA (MDL NO. 3044) (NGG) (MMH). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PREMATURE, UNNECESSARY REVISION SURGERY. TISSUE AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 20034868 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA (MASTER CASE 2022 (B)(4)) CASE NO: (B)(4). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20022103 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 141 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19983033 ↗
• InjuryAug 12, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  LEGAL CASE - USA. PATIENT ID: RAYNI BORINSKY RK REV. THIS PATIENT IS VERIFIED RIGHT KNEE ON (B)(6) 2012 AT HOSPITAL FOR SPECIAL SERVICE. SHE HAD RIGHT KNEE REVISION (B)(6) 2024 WITH DR PETER SCULCO (OP REPORT ATTACHED). PLEASE REVIEW THE ATTACHED REVISION OP REPORT AND CONFIRM THIS IS WITHIN THE SCOPE OF THE RECALL. MATCH FOUND ON EXACTECH MASTER LIST. RIGHT KNEE (B)(6) 2012 WITH DR. (B)(6). CLAIM IS NOW ACCEPTED AS COMPENSABLE. DATE OF LOSS: (B)(6) 2012. PATIENT FIRST NAME: (B)(6). PATIENT LAST NAME: (B)(6). PATIENT STREET ADDRESS: (B)(6). PATIENT CITY: (B)(6). PATIENT STATE: NJ PATIENT ZIP CODE: (B)(6). PATIENT PHONE NUMBER: (B)(6). PATIENT BIRTH DATE: (B)(6) 1956. SERIAL NUMBER: (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE EBI INITIAL SURGERY. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. (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. UDI: (B)(4). 510K: K033883.

  Patient problems: Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 19966447 ↗
• InjuryAug 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19959341 ↗
• InjuryAug 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 96 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19937476 ↗
• InjuryAug 6, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARPAIN, SWELLING, STIFFNESS, LOSS OF MOTION, WEAKNESS, DIFFICULTY AMBULATING, SURGICAL REVISION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19919701 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR UNKNOWN ISSUES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 19827259 ↗

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-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