Optetrak Logic 02-010-01-0350Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10885862001269), received between Sep 17, 2020 and Feb 12, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (34 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Unstable

  AS REPORTED, APPROXIMATELY 5 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN AND INSTABILITY AND WAS REVISED. THE SURGEON REMOVED THE FEMUR AND TIBIA INSERT SIZE 5/9MM. THE PATIENT WAS REVISED TO A SIZE 5 CONDYLAR CONSTRAINED FEMUR 20X120 STEM AND SIZE 5/13MM CONSTRAINED INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24327738 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND FEMORAL DEBONDING/LOOSENING. THERE WAS ALSO PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT KNEE JOINT. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23631745 ↗
• InjuryNov 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH A FAILED RIGHT TOTAL KNEE REPLACEMENT REFRACTORY TO CONSERVATIVE MANAGEMENT. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PAIN, SWELLING, AND DIFFICULTY WALKING DUE TO POLY WEAR. IMAGING WAS CONSISTENT WITH A FAILED RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS INDICATED FOR SURGERY. APPROXIMATELY 9 YEARS POST THE INITIAL RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT WAS REVISED. A THOROUGH SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS DISLOCATED AND THE KNEE WAS FLEXED. THE FEMORAL IMPLANT WAS REMOVED WITH MINIMAL BONE LOSS. ATTENTION WAS THEN TURNED TO THE TIBIA. THE TIBIA WAS REMOVED WITH MINIMAL BONE LOSS. ALL CEMENT WAS REMOVED FROM THE TIBIA. THE FEMORAL AND TIBIAL CANALS WERE REAMED. PRIOR TO PLACING THE FINAL COMPONENTS, A FEMORAL HEAD ALLOGRAFT WAS OPENED AND CUT TO FILL THE VOID OF BONE DUE TO OSTEOLYSIS ON BOTH THE MEDIAL AND LATERAL CONDYLES OF THE FEMUR. CEMENT RESTRICTORS WERE PLACED IN THE TIBIAL AND FEMORAL CANALS. A TIBIAL CONE WAS IMPACTED INTO THE TIBIA AND FIT WELL. CANALS WERE IRRIGATED, SUCTIONED, AND DRIED. ALL IMPLANTS WERE CEMENTED INTO PLACE USING PRESSURIZED CEMENT TECHNIQUE IN THE TIBIAL AND FEMORAL C

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 23521708 ↗
• InjuryMar 7, 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 RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, POSSIBLE NICKEL ALLERGY, EXTENSIVE DAMAGE TO THE POSTERIOR ASPECT OF THE POLYETHYLENE AS WELL AS TO THE POST, SOFT TISSUE CHANGES CONSISTENT WITH EXTENSIVE POLY WEAR, FRAGMENTS OF POLY FOUND IN SOFT TISSUE, POLY WEAR OF THE PATELLA BUTTON, AND A LOOSE FEMORAL COMPONENT. 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; Hypersensitivity/Allergic reaction; Implant Pain; Osteolysis

  MAUDE report 21552483 ↗
• InjuryMar 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 93 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, DISCOMFORT, EMOTIONAL CHANGES, JOINT EFFUSION, JOINT LAXITY, LOSS OF RANGE OF MOTION AND SYNOVITIS. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Joint Laxity; Joint effusion; Loss of Range of Motion; Synovitis

  MAUDE report 21547238 ↗
• InjuryJan 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION OP REPORT FINDINGS: 1. THE PATIENT HAD A MARKED SYNOVITIS. 2. THE PATELLA BUTTON WAS SOLIDLY FIXED BUT HAD SIGNIFICANT WEAR AND DELAMINATION OF THE BUTTON. 3. THE FEMORAL IMPLANT HAD MICRO MOTION AND WAS DEBONDED FROM THE UNDERLYING CEMENT MANTLE. THERE WAS EXTENSIVE OSTEOLYSIS IN THE DISTAL FEMUR, PARTICULARLY IN THE LATERAL CONDYLE AND COMPLETE EROSION OF THE POSTERIOR LATERAL CONDYLE. 4. THE TIBIA IMPLANT WAS FOUND TO BE SOLIDLY FIXED, BUT THERE IS EXTENSIVE UNDERLYING OSTEOLYSIS, ESPECIALLY IN THE ENTIRE MEDIAL TIBIA, WHICH WAS DOWN TO A VERY THIN CORTICAL RIM AND THERE WAS SOME FUL1-THICKNESS STRUCTURAL DEFECT. OP REPORT FURTHER STATES THAT THE TIBIAL LINER WAS EXTRACTED AND FOUND TO HAVE WEAR AND SOME AREAS OF DELAMINATION. *ORIGINAL DESCRIPTION SUMMARY* AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT. APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION. 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 I

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21241717 ↗
• InjuryJan 21, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  *ADDITIONAL INFORMATION OBTAINED FROM LEGAL ON 10AUG2023*. LEGAL CASE - RK REV. IMPLANTATION PRODUCT: ¿ FEMORAL CEM RT (02-010-01-0350, (B)(6)). ¿ TRAY TIBIAL (02-012-41-5050, (B)(6)). ¿ TIBIAL INSERT (02-012-44-5015, (B)(6)). ¿ PATELLA 3 PEG (200-02-35, (B)(6)). ¿ STRYKER BONE CEMENT. DATE OF SURGERY: (B)(6) 2014. SURGEON: (B)(6) SWANSON, MD. PLACE: (B)(6) CLINIC ¿ MANKATO, MN. SPECIFICS: ¿ ADVANCED RIGHT VARUS GONARTHROSIS. OBESITY. ¿ RIGHT TKA. REVISION PRODUCT: ¿ ZIMMER PERSONA REVISION TOTAL KNEE SYSTEM. DATE OF SURGERY: (B)(6) 2023. SURGEON: (B)(6), MD. PLACE: (B)(6) CLINIC ¿ MANKATO, MN. SPECIFICS: ¿ PAIN TKA. ¿ ¿IT WAS NOTED THAT THE TIBIAL POLYETHYLENE COMPONENT WAS NOT ENGAGED IN THE LOCKING MECHANISM ANY LONGER AT THIS POINT. WAS A FAIR BIT OF WEAR PARTICULARLY POSTERIORLY ON THE FEMUR AS WELL AS SOME UNDERSURFACE WEAR. ADDITIONALLY, 1 OF THE THIN METALLIC CAPS COVERING ALL HOLES ON THE TIBIAL TRAY HAD COME LOOSE AS WELL. THERE WAS EXTENSIVE AMOUNT OF SYNOVITIS IN THE MEDIALAND LATERAL GUTTERS. A COMPLETE SYNOVECTOMY WAS PERFORMED.¿ ¿THE LATERAL FEMORAL CONDYLE HAD A VERY LARGE OSTEOLYTIC LESION BUT DID HAVE AN INTACT PERIPHERAL CORTEX.¿ ¿ REVISION RIGHT TKA. PRODUCT INF

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 21200666 ↗
• InjuryJan 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, PAIN, OSTEOLYSIS, 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: Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 21152547 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 10 YEARS 8 MONTHS AFTER THEIR INITIAL PROCEDURE. PATIENT EXPERIENCED LOOSENING, JOINT LAXITY, IMPLANT PAIN, SYNOVITIS AND FAILURE OF IMPLANT. ON (B)(6) 2023 OP REPORT INTRAOPERATIVE FINDINGS INCLUDE LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MODERATE BONE LOSS. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUE. THERE WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE. THE SURGEON NOTED THERE WAS EXCESSIVE WEAR WITH SIGNS OF OXIDATION / YELLOW DISCOLORATION, PITTING, CRACKING, AND DELAMINATION OF THE POLYETHYLENE. DISTAL FEMORAL AND ANTERIOR FEMORAL BONE LOSS WAS MODERATE. TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRED PLACEMENT OF A TIBIAL CONE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Synovitis

  MAUDE report 21060450 ↗
• InjuryJan 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 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN, JOINT EFFUSION, 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: Joint effusion; Osteolysis; Pain

  MAUDE report 21057812 ↗
• InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN, OSTEOLYSIS, AND FAILURE OF IMPLANT. 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; Pain

  MAUDE report 21034807 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, SYNOVITIS, OSTEOLYSIS, AND 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: Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 20906080 ↗
• InjuryDec 6, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT. APPROXIMATELY 61 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION. THE PATIENT WAS EXPERIENCING PROTHESIS WEAR, INSTABILITY, LOOSENING, IMPLANT PAIN, OSTEOLYSIS, SYNOVITIS, JOINT EFFUSION, JOINT LAXITY. THE PATIENT 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: Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20870007 ↗
• InjuryDec 6, 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 RIGHT KNEE REPLACEMENT. APPROXIMATELY 98 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION. POLYETHYLENE WEAR WITH FEMORAL LOOSENING WAS NOTED. THE PATIENT WAS EXPERIENCING OSTEOLYSIS, FAILURE OF IMPLANT, SYNOVITIS, JOINT EFFUSION, AND IMPLANT PAIN. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY 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: Failure of Implant; Implant Pain; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20864678 ↗
• InjuryDec 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 8 YEARS 5 MONTHS POST PRIMARY PROCEDURE. ON (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED BILATERAL TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. THE RIGHT PATELLA WAS FOUND TO BE WELL FIXED. THE FEMORAL COMPONENT WAS EASILY DISIMPACTED FROM THE INTACT CEMENT MANTLE. TIBIA WAS CHECKED AND WAS FOUND TO BE WELL FIXED. THERE WAS A LARGE CYST POSTERIOR LATERAL, WHICH WAS NOT DECOMPRESSED FROM THE ARTHROTOMY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint effusion; Synovitis

  MAUDE report 20824216 ↗
• InjuryNov 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 72 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SYNOVITIS, 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. 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: Osteolysis; Synovitis

  MAUDE report 20776153 ↗
• InjuryNov 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 90 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT IN THE KNEE WITH SWELLING. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: FAILED TOTAL KNEE ARTHROPLASTY, RIGHT. FINDINGS: THERE WAS SIGNIFICANT FLUID AND SYNOVITIS THROUGHOUT THE JOINT. THERE WAS SOME QUESTIONABLE LOOSENING FROM THE SUPERIOR FLANGE. IT WAS EASILY DEBONDING THE FEMORAL COMPONENT FROM THE CEMENT WAS EASILY DONE. BEHIND THIS, THERE WAS A SIGNIFICANT CYST IN THE LATERAL FEMORAL CONDYLE. DESCRIPTION OF PROCEDURE: FLUID WAS EXPRESSED. AFTER REMOVING ALL THE FLUID, THERE WAS SIGNIFICANT SYNOVITIS, AND EXTENSIVE DEBRIDEMENT WAS PERFORMED EXTERNALLY AND INTERNALLY. THE TIBIA WAS REMOVED. THERE WAS SIGNIFICANT POSTERIOR WEAR OF THE POLY WITH SOME DELAMINATION AT THE VERY POSTERIOR CORNER, ESPECIALLY LATERALLY. WE THEN BEGAN EVALUATING THE FEMORAL COMPONENT. WE WERE CONCERNED THERE WAS SOME LOOSENING AND INDEED IT WAS EASILY ABLE TO BE REMOVED WITH OSTEOTOMES DEBONDING FROM THE CEMENT. WE ALSO NOTED THERE WAS A LARGE CYST, MARBLE SIZE OF THE LATERAL FEMORAL CONDYLE. THE PATIE

  Patient problems: Cyst(s); Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20738572 ↗
• InjuryNov 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 7 YEARS AND 6 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, JOINT EFFUSION, OSTEOLYSIS, BALANCE PROBLEMS, AMBULATION OR POSTURAL DIFFICULTIES, DISCOMFORT, PAIN, SYNOVITIS. 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; Balance Problems; Discomfort; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20641803 ↗
• InjuryOct 23, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THE PATIENT HAS SINCE REPORTED EXPERIENCING SIGNIFICANT PAIN, CLICKING OF THE KNEE, SWELLING, AND IMPAIRED MOBILITY. A RIGHT KNEE X-RAY TAKEN DURING OR AFTER A (B)(6) 2023 DOCTOR VISIT REVEALED ¿NOTABLE POLY WEAR¿ AND ¿A LARGE AREA OF SWELLING IN THE POSTERIOR ASPECT ON THE LATERAL VIEW.¿ REVISION SURGERY WAS RECOMMENDED, HOWEVER, DUE TO THE PATIENT'S ADVANCED AGE, THEY ARE STILL CONSIDERING WHETHER THEY WILL UNDERGO AN ADDITIONAL SURGERY TO REMOVE 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: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 20515469 ↗
• InjurySep 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 100 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO PROSTHESIS WEAR, ASEPTIC LOOSENING, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 20146586 ↗
• InjuryAug 21, 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 RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING, PHYSICAL INJURY AND BODILY IMPAIRMENT, MENTAL ANGUISH AND EMOTIONAL DISTRESS, AND PHYSICAL LIMITATIONS. 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; Pain

  MAUDE report 20012614 ↗
• InjuryMar 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 67-YEAR-OLD PATIENT HAD A RIGHT TKA ON (B)(6) 2015. THE PATIENT PRESENTED WITH EFFUSION / LUCENCY - MILD EFFUSION AND MINOR LUCENCIES UNDER SUPERIOR ASPECT OF ANTERIOR FEMORAL FLANGE. INPATIENT HOSPITALIZATION FOR REVISION SURGERY TO RIGHT KNEE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE REPORT INDICATES THAT THE ACTION TAKEN IS REVISION ON (B)(6) 2024. COMPONENTS ARE BEING REVISED ARE FEMORAL, PATELLA, TIBIAL INSERT, TIBIAL TRAY PATIENT WAS ADVISED AND DEMONSTRATED QUADRICEPS STRENGTHENING EXERCISES. ADVISED TO MINIMIZE USE OF ELASTICATED SUPPORT. REVIEW IN 2 YEARS TIME WITH X-RAY. PT EVENTUALLY HAD REVISION SURGERY ON (B)(6) 2024. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant; Joint effusion

  MAUDE report 18918664 ↗
• InjuryFeb 22, 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 A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6)2023 APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. UPON THE REVISION OF THE OPTETRAK LOGIC DEVICE, PATIENT'S SURGEON OBSERVED SIGNS OF DEFECTIVE AND LOOSE FEMORAL COMPONENTS. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18760332 ↗
• InjuryFeb 6, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A 70 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 9 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THE SUBMITTED REPORT INDICATED THE PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. THE RECALLED POLY AND PATELLA COMPONENT WERE REPLACED. X-RAY IMAGES WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURN FOR ANALYSIS ANTICIPATED. DUE TO RECALL HOSPITAL WILL NOT RELEASE. IMAGES OF THE DEVICES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 18654648 ↗
• InjuryNov 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7.5 YEARS RIGHT TKA, THE 62 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGE RECEIVED. THE DEVICES ARE NOR AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE. RECALL IMPLANTS .

  Patient problems: Failure of Implant

  MAUDE report 18145459 ↗

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