Optetrak Logic 02-012-35-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862001771), received between Jul 8, 2021 and Jan 22, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Naturally Worn” (25 reports).

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

1 other recall 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.

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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Naturally Worn

  REPORT 2 OF 2 FOR THIS EVENT: IT WAS REPORTED A PATIENT HAD AN INITIAL TOTAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, ELEVEN (11) YEARS LATER, THE PATIENT EXPERIENCED ASEPTIC FEMORAL LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE OF THE FEMORAL AND TIBIAL COMPONENTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 24144376 ↗
• InjuryJan 5, 2026Naturally Worn; Insufficient Device Problem Information

  PATIENT UNDERWENT REVISION PROCEDURES ON BOHT KNEES. BOTH KNEES BEGAN TO FAIL AND HAVE SWELLING AND PAIN. THE PATIENT INDICATED THE EXPLANTED DEVICES WERE CLEARLY AT FAULT DUE TO THE PARTICLES OF THE POLYETHYLENE DISSOLVING THE BONES.

  Patient problems: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 23968427 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA ((B)(4)). (B)(4) LK REV IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 98 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. THE RIGHT KNEE IS UNREVISED AT THIS TIME. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429732 ↗
• InjurySep 13, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING AND INSTABILITY. 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: Joint Laxity; Swelling/ Edema

  MAUDE report 20211493 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 110 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYSIS, SYNOVITIS, EFFUSION AND LOOSENING. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20065918 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 20012661 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS THE "(LYSIS) DUE TO THE SPINE OF THE LINER BEING RUBBED UP AGAINST". PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: UNABLE TO OBTAIN THEM.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 19623726 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 8 YEARS, 11 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 19616318 ↗
• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 112 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, DISCOMFORT, PAIN, AND SWELLING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Implant Pain; Swelling/ Edema

  MAUDE report 19453014 ↗
• InjuryMay 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 116 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, KNEE PAIN, SWELLING, EXACTECH KNEE IMPLANT UNSTABLE, AND KNEE COMPONENT LOOSENING. 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; Swelling/ Edema

  MAUDE report 19387030 ↗
• InjuryMay 21, 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 THAT APPROXIMATELY 24 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FLEXION INSTABILITY WITH RECURRENT EFFUSIONS. 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: Failure of Implant; Joint Laxity; Joint effusion; Loss of Range of Motion

  MAUDE report 19367861 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FAILURE OF KNEE DEVICE, AND COMPONENT MALROTATION. 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

  MAUDE report 19312422 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL SHORT FORM THAT APPROXIMATELY 95 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SIGNIFICANT PAIN AND DISCOMFORT, SWELLING, STIFFNESS, MOBILITY AND GAIT IMPAIRMENT, DIFFICULTY ASCENDING STAIRS, LIMITED ABILITY TO STAND AND SIT FOR LONG PERIODS OF TIME, PREMATURE POLYETHYLENE WEAR, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19298412 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO A RECALLED POLY. THE POLY WAS SWAPPED OUT FOR A NON-RECALLED ONE. 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: Failure of Implant; Insufficient Information

  MAUDE report 19297748 ↗
• InjuryMay 13, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 151 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, INSTABILITY, WEAR OF THE PATELLA, AND SIGNIFICANT LAXITY. INITIAL 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; Emotional Changes; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19296915 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT. OP REPORT - POSTOPERATIVE DIAGNOSIS ; FAILED RIGHT TOTAL KNEE POLYETHYLENE PREMATURE WEAR AND FAILED LOOSE FEMORAL COMPONENT DUE TO OSTEOLYSIS FROM POLY WEAR NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 19131261 ↗
• InjuryMar 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2022, APPROXIMATELY 5 YEARS, 10 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2022- POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE DUE TO POLYETHYLENE RECALL AND OSTEOLYSIS. THERE WAS FOUND TO BE A SEVERELY WORN POLYETHYLENE OF THE TIBIAL COMPONENT. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18944481 ↗
• InjuryMar 4, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18826933 ↗
• InjuryJul 19, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 53 Y/O FEMALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON 8 DEC 2022 DIAGNOSIS: RIGHT INSTABILITY OF KNEE PROSTHESIS INTRAOPERATIVE FINDINGS REVEALED A MODERATE TO LARGE AMOUNT OF NORMAL-APPEARING JOINT FLUID. ALL COMPONENTS APPEAR TO BE WELL FIXED AND IN GOOD POSITION. THERE WAS MEDIAL TIBIAL OSTEOLYSIS AFFECTING ABOUT 20% OF THE COMPONENT. THERE WAS A LARGE AMOUNT OF POSTERIOR CONDYLAR OSTEOLYSIS ON THE LATERAL SIDE OF THE FEMUR. THE POLYETHYLENE LINER HAD SEVERE WEAR ON THE MEDIAL SIDE WITH PITTING AND DELAMINATION. THERE WERE NO COMPLICATIONS. THE PATIENT WAS THEN TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

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

  MAUDE report 17349409 ↗
• InjuryJun 30, 2023Crack; Naturally Worn; Crack; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2016 DUE TO ADVANCED OSTEOARTHROSIS. THEY UNDERWENT RIGHT KNEE REVISION SURGERY (B)(6) 2023, APPROXIMATELY 6 YEARS 8 MONTHS AFTER THEIR PRIMARY PROCEDURE. ACCORDING TO THE (B)(6) 2023 OP REPORT: THE CLASSIC INCREASED SYNOVITIS WAS NOTED. NO PURULENCE WHATSOEVER. THE SYNOVIUM WAS THICKENED, POLYETHYLENE ENGORGED SYNOVIUM. THIS WAS DEBRIDED, WHICH WAS SIGNIFICANT AMOUNT. THE POLYETHYLENE HAD SOME SIGNIFICANT MEDIAL COMPARTMENT WEAR IN THE POSTERIOR ASPECT OF THE TIBIAL SPINE THAT WAS ALSO SIGNIFICANTLY WORN. THERE WERE SOME LARGE MACRO CRACKS IN THE MEDIAL PLATEAU ALSO. THE FEMORAL COMPONENT WAS STABLE WHEN STRESSED. THE TIBIAL COMPONENT WAS STABLE ALSO. THE PATELLAR COMPONENT WAS ENCASED IN SOME SIGNIFICANT SCAR AND SYNOVITIS, WHICH WAS DEBRIDED. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO APPARENT INTRAOPERATIVE COMPLICATIONS. ALL COUNTS WERE CORRECT. NO BREAKS IN STERILE TECHNIQUE. NO SIGNIFICANT SPECIMEN. 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.

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

  MAUDE report 17240632 ↗
• InjuryJun 8, 2023Naturally Worn; Naturally Worn

  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. 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 ON (B)(6) 2020. POST-OP DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO OSTEOLYSIS. ASEPTIC LOOSENING FEMORAL COMPONENT LEFT TOTAL KNEE. LARGE CORTICAL OSTEOLYTIC DEFECT NON-CONTAINED 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 NON-CONTAINED 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.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 17088767 ↗
• InjuryMar 13, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2013. THEY HAD LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 9 YEARS 5 MONTHS AFTER THEIR PRIMARY PROCEDURE. (B)(6) 2022 OP REPORT POST-OP DIAGNOSIS: WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT KNEE JOINT. THE LEFT KNEE WAS NOTED TO SHOW MODERATE EFFUSION WITH SIGNIFICANT JOINT LAXITY. DURING SURGERY, THE PATIENT WAS NOTED TO HAVE SIGNIFICANT EFFUSION AND SYNOVITIS. THERE WAS DELAMINATION OF THE POLYETHYLENE BUT NO EVIDENCE OF PROSTHESIS LOOSENING. THE PATELLA WAS REMOVED BECAUSE IT WAS WORN AND LOOSE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM 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: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16529308 ↗
• InjuryFeb 27, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  ADDITIONAL INFORMATION VIA LEGAL DEPARTMENT-THE PATIENT WAS REVISED TO COMPETITOR'S DEVICES. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: 1. INSTABILITY AFTER TOTAL KNEE REPLACEMENT, 2. RECALLED KNEE REPLACEMENT 3. OSTEOLYSIS/SYNOVITIS. REVISION OF RIGHT TOTAL KNEE, BOTH COMPONENTS. FINDINGS: INTRAOPERATIVELY THERE WAS A LARGE EFFUSION, THERE WAS SIGNIFICANT SYNOVITIS THROUGHOUT THE SUPRAPATELLAR POUCH MEDIAL AND LATERAL GUTTERS. THE POLYETHYLENE WAS NOTED TO BE WORN AND OXIDIZED. THE TIBIAL AND FEMORAL COMPONENT WERE FOUND TO BE WELL FIXED-THEY WERE REMOVED. THE DEVICES WERE TRAILED AND THEN IMPLANTED. THERE WERE NO SURGICAL COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. HOSPITAL CARE TIME-ADMITTED (B)(6) 2023, DISCHARGED ON (B)(6) 2023. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Joint Laxity; Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 16449211 ↗
• InjurySep 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 78 Y/O FEMALE PATIENT HAS HAD A TOTAL RIGHT KNEE REVISION DUE TO FEMORAL LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNING, HOSPITAL DISPOSED OF THEM.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 15484037 ↗
• InjurySep 9, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 APPROXIMATELY 2 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15395407 ↗

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-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