Optetrak Logic 02-010-01-0250Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10885862001177), received between Nov 21, 2019 and Mar 31, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (39 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, TEN (10) YEARS, THREE (3) MONTHS LATER, THE PATIENT EXPERIENCED PAIN AND OSTEOLYSIS AND ASEPTIC (NON-INFECTED) LOOSENING. ADDITIONALLY, AS REPORTED VIA LEGAL DOCUMENTATION, THE PATIENT CONTINUES TO EXPERIENCE PAIN, DISCOMFORT, DIFFICULTY WALKING, BALANCE ISSUES AND SOFT TISSUE DAMAGE. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION. A REVISION OPERATIVE REPORT WAS PROVIDED. THE PRE AND POST DIAGNOSIS WAS NOTED AS POLYETHYLENE WEAR, OSTEOLYSIS AND FEMORAL LOOSENING. INTRAOPERATIVELY, IT WAS OBSERVED THAT THE FEMORAL COMPONENT WAS LOOSE AND THE TIBIAL COMPONENT WAS WELL FIXED WITH A SUBSTANTIAL AMOUNT OF MEDIAL OSTEOLYSIS. THE PATELLAR COMPONENT WAS WELL FIXED, AND THE SURGEON ELECTED TO RETAINED DUE TO CONCERNS OF A WELL-FIXED COMPONENT THAT MAY HAVE RESULTED IN UNNECESSARY PATELLAR BONE LOSS. FINAL RELOCATION OF THE REVISION ARTHROPLASTY REVEALED A STABLE REPLACEMENT. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 24740713 ↗
• 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 82 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, CYST(S), JOINT LAXITY, OSSIFICATION, SCAR TISSUE, 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: Cyst(s); Extraskeletal ossification; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21528917 ↗
• InjuryMar 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, POLYETHYLENE WEAR, SYNOVITIS, PAIN, AND SWELLING. 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: Cyst(s); Implant Pain; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21525781 ↗
• InjuryFeb 25, 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 154 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, IMPLANT PAIN AND INSTABILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING, INSTABILITY. INTRAOPERATIVELY THE SURGEON OBSERVED AN INTACT PATELLA COMPONENT BUT WITH SIGNS OF WEAR. IT WAS NOTED THAT IT WAS ELECTED TO EXPLANT DUE TO THE RECALL. IT WAS NOTED THE POLYETHYLENE WAS SIGNIFICANTLY WORN WITH PITTING. THE SURGEON OBSERVED THE FEMORAL COMPONENT DEBONED FROM ITS CEMENT MANTLE, AND AFTER REMOVING, OBSERVED SIGNIFICANT BONE LOSS RESPECTIVE TO THE LATERAL CONDYLE. THE TIBIAL TRAY WAS FOUND TO BE INTACT AND NOT LOOSE. NO SURGICAL OR MEDICAL INTERVENTIONS 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; Joint Laxity; Osteolysis

  MAUDE report 21461973 ↗
• InjuryJan 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 59 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS MECHANICAL LOOSENING; SYNOVITIS, OSTEOLYSIS, POLYETHYLENE WEAR OF THE TIBIAL INSERT AND PATELLA, LOOSENING OF THE FEMUR AND PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 21240028 ↗
• InjuryJan 24, 2025Loosening 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 ASEPTIC FEMORAL COMPONENT LOOSENING AND OSTEOLYSIS. PATIENT WAS ALSO INDICATED FOR PAIN AND OSTEOARTHRITIS. DURING THE PROCEDURE IT WAS NOTED OSTEOLYTIC DEBRIS IN THE SYNOVIUM. THE PATELLA HAD SIGNIFICANT WEAR AND OXIDATION WITH OSTEOLYSIS ON THE LATERAL BORDER. TAPPING ON THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT EASILY DEBONDED IT FROM THE CEMENT. A LARGE OSTEOLYTIC CONTAINED CYST IN THE LATERAL FEMORAL CONDYLE. (SEE REVISION SURGERY OPERATIVE NOTES). 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. EBI INITIAL SURGERY ATTACHED. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. X-RAY: NO OPERATIVE NOTES: YES.

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

  MAUDE report 21229734 ↗
• InjuryJan 16, 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 UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, FAILURE OF IMPLANT, AND SYNOVITIS. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain; Synovitis

  MAUDE report 21173074 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 121 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, DISCOMFORT, FAILURE OF IMPLANT, IMPLANT PAIN AND OSTEOLYSIS. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 21069693 ↗
• InjuryDec 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; 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 LOOSENING, POLYETHYLENE WEAR, PAIN AND OSTEOLYSIS. 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: Osteolysis

  MAUDE report 20924342 ↗
• InjuryDec 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 101 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, JOINT EFFUSION, AND SYNOVITIS. 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; Joint effusion; Synovitis

  MAUDE report 20825256 ↗
• InjuryNov 21, 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 LEFT KNEE REVISION. APPROXIMATELY 35 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION. THE PATIENT EXPERIENCED JOINT LAXITY, OSTEOLYSIS AND SYNOVITIS. 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: Joint Laxity; Osteolysis; Synovitis

  MAUDE report 20748412 ↗
• InjuryNov 6, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 128 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAINFUL LEFT KNEE IMPLANT 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20623099 ↗
• InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 9 YEARS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMORAL COMPONENT, RECALLED INSERT AND PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20614926 ↗
• InjuryOct 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 125 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, OSTEOLYSIS, SYNOVITIS, LOOSENING OF FEMORAL AND TIBIAL TRAY, INTRAOPERATIVE FRACTURE OF FEMUR. HIS LEFT KNEE HAD BECOME EXTREMELY PAINFUL, AND HE HAS GONE ON TO HAVE MASSIVE OSTEOLYSIS IN THE DISTAL FEMUR AND PROXIMAL TIBIA WITH LOOSENING. HE WAS INDICATED FOR A SEMI URGENT REVISION KNEE REPLACEMENT. UPON MAKING ARTHROTOMY, THERE WAS EVIDENCE OF MASSIVE SYNOVITIS WITH OSTEOLYTIC TISSUE. THE POLYETHYLENE WAS REMOVED. THERE WAS EVIDENCE OF BONE LOSS ON THE TIBIA AND THE FEMUR. BOTH THE FEMUR AND THE TIBIA WERE LOOSE, BUT NOT GROSSLY LOOSE. UPON REMOVING THE FEMUR, THERE WAS MASSIVE OSTEOLYSIS WITH A GIANT CAVITARY DEFECT WITH ALMOST NO CONDYLES, JUST AXIAL CONDYLE. WHILE TRIALING, THE ATTENTION FROM THE CONSTRUCT CAUSED A FRACTURE OF THE MEDIAL FEMORAL CONDYLE GIVEN HOW POOR HIS BONE QUALITY WAS. NO OTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20533970 ↗
• InjurySep 25, 2024Unstable; 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 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20301603 ↗
• InjurySep 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 11 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED AND EVERYTHING REMOVED DUE TO SUSPECTED IMPLANT LOOSENING IN FEMUR AND POLY WEAR/LYSIS. 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: Osteolysis

  MAUDE report 20141080 ↗
• InjurySep 3, 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 KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND ASEPTIC FEMORAL LOOSENING SECONDARY TO OSTEOLYSIS. THE PATIENT HAS HAD RECURRENT AND PERSISTENT EFFUSIONS WITH INCREASING WEIGHTBEARING PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20125992 ↗
• InjuryAug 23, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ UNITED STATES (MDL NO. (B)(4)). RELATED CASE FOR REVISION OF RK DOCUMENTED ON (B)(4). IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, RECURRENT EFFUSIONS, EXTENSIVE SYNOVITIS, OSTEOLYSIS, ASEPTIC LOOSENING OF FEMUR AND TIBIA, AND GROSSLY LOOSE PATELLA; DELAMINATED POLYETHYLENE DEBRIS. 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; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20053660 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 88 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, REHABILITATION, PAIN AND SUFFERING, PAST AND FUTURE COST OF MEDICAL CARE, LOSS OF EARNING CAPACITY, AND MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Joint effusion; Osteolysis; Pain

  MAUDE report 20049335 ↗
• InjuryAug 23, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND AORI 2A BONE ON LOSS FEMUR, 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: Joint Laxity; Medical device site infection; Osteolysis; Synovitis

  MAUDE report 20048782 ↗
• InjuryJun 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE LEFT KNEE AND THEN APPROXIMATELY 12 YEARS, 8 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED ABOUT THE PATIENT THAT THEY HAD ¿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.¿ 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: Abdominal Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 19577203 ↗
• InjuryJun 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING. THE PATIENT WAS INDICATED FOR SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF LEFT TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INTRAOPERATIVE FINDINGS NOTE LOOSE FEMORAL IMPLANT REMOVED EASILY WITH MINIMAL BONE LOSS. THE BACKSIDE OF THE FEMORAL IMPLANT WAS 100% CLEAN WITHOUT ANY CEMENT ATTACHED. ALL OF THE CEMENT WAS ON THE DISTAL FEMUR. ON THE BACKSIDE OF THE CEMENT WAS SIGNIFICANT OSTEOLYSIS FROM POLY WEAR THAT HAD DESTROYED THE BONE. THERE WAS EXTENSIVE SOFT TISSUE DAMAGE THROUGHOUT THE KNEE JOINT AS A RESULT OF OSTEOLYSIS AS WELL. PATELLA BUTTON WAS WELL FIXED AND STABLE. 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; Failure of Implant; Osteolysis; Pain

  MAUDE report 19499577 ↗
• InjuryJun 7, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; 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 PROSTHESIS WEAR, PAIN, INSTABILITY, SYNOVITIS, LOOSENING, AND OSTEOLYSIS. 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; Extraskeletal ossification; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19489007 ↗
• InjuryDec 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR AND RECALLED POLY. 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; Joint Laxity; Pain

  MAUDE report 18334648 ↗
• InjuryDec 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YEARS POST OP INITIAL LEFT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 18266080 ↗

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