Optetrak Logic 02-012-35-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10885862001894), received between Aug 11, 2020 and Feb 3, 2026 — classified as 78 injuries.

The most frequently reported specific device problem is “Naturally Worn” (65 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 78 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE REPLACEMENT. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY, APPROXIMATELY (B)(6) YEARS (B)(6) MONTHS POST PRIMARY PROCEDURE. DURING WHICH, ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, MARKED PERIPROSTHETIC OSTEOLYSIS, AND SEVER PAIN AND SYNOVITIS WERE NOTED. AS WELL AS PROSTHESIS WEAR OF THE TIBIAL INSERT. 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: Aseptic loosening; Osteolysis; Pain; Synovitis

  MAUDE report 24246945 ↗
• InjurySep 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TKA (TOTAL KNEE ARTHROPLASTY). SUBSEQUENTLY, AN X-RAY WAS TAKEN OF THE KNEE SHOWED POLYETHYLENE WEAR AND MILD EFFUSION. THERE WAS NO EVIDENCE OF OSTEOLYSIS. SURGEON IS MONITORING THE FOR ONE YEAR. THE DEVICES REMAIN IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint effusion

  MAUDE report 23096232 ↗
• InjuryJun 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THIS PATIENT WAS IMPLANTED WITH A TOTAL KNEE ARTHROPLASTY (TKA). THE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR. PATIENT HAD A LOOSE FEMUR WITH OSTEOLYTIC CAVITIES AND POSTERIOR TIBIAL DEFECT. REVISED TO COMPETITORS DEVICE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 22306372 ↗
• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 64 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON NOVEMBER 2015, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2023, APPROXIMATELY 8 YEARS POST THE INITIAL PROCEDURE. THE PATIENT HAS HAD INCREASING EFFUSIONS AND PAIN FOR THE LAST 2-3 YEARS. INFECTION WORK-UP WAS NEGATIVE. PREOPERATIVE DIAGNOSIS INDICATED A FAILED BILATERAL TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, OSTEOLYSIS. OPERATIVE NOTES INDICATED THERE WERE OSTEOLYTIC DEBRIS AND SYNOVIAL INFLAMMATION. A SUBTOTAL SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS EVERTED AND FOUND TO BE OXIDATED AND DELAMINATED. THE PATELLA WAS PREPARED FOR A 35MM PATELLA BUTTON WITH A COMPOSITE THICKNESS IF 24MM. THE INSERT WAS REMOVED. THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND WELL FIXED. A 13 INSERT WAS IMPLANTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE THEM. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THE LEFT KNEE. RIGHT KNEE REVISION REPORTED UNDER MDR#1038671-2023-02900 AND 1038671-2025-01517.

  Patient problems: Inflammation; Joint effusion; Osteolysis; Pain

  MAUDE report 21568992 ↗
• InjuryMar 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED. REASON FOR THE REVISION WAS NOT REPORTED. PATIENT WAS REVISED TO TRULIANT TIBIAL PS MOD SIZE 4 11MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21530001 ↗
• InjuryJan 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 75 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ANTERIOR KNEE PAIN, FRAGMENTED PATELLA, LOOSE AND SOME CEMENT PARTICLE, TIBIA LOOSENING, PROSTHESIS WEAR, BONE SHEDDING DEBRIS, OSTEOLYSIS, UNSPECIFIED TISSUE INJURY, JOINT LAXITY, SWELLING/ EDEMA, SYNOVITIS, PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES WILL BE RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Shedding Debris; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 21230123 ↗
• InjuryJan 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 168 MONTHS AFTER A LEFT 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 21167524 ↗
• InjuryDec 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A 67 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED, UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY PROCEDURE APPROXIMATELY 11 YEARS POST THE INITIAL PROCEDURE. THE PATIENT WAS HAVING SWELLING AND DISCOMFORT WITH ACTIVITY. PREOPERATIVE DIAGNOSIS INDICATED A FAILED TOTAL KNEE ARTHROPLASTY WITH EFFUSION, WITH CONCERN FOR POLY WEAR. RISKS, COMPLICATIONS, AND ALTERNATIVES WERE DISCUSSED, THE PATIENT AGREED TO THE PLANNED PROCEDURE. INCISION WAS MADE. THE PATELLA WAS EVALUATED AND FOUND TO HAVE MINIMAL IF ANY WEAR. THE EDGE OF THE PATELLA WAS COMPLETELY PRISTINE WITH NO EVIDENCE OF LOOSENING OR DEBRIDEMENT. THERE WAS NO EVIDENCE OF LOOSENING OR ROCKING OF THE PROXIMAL TIBIA. ATTENTION TURNED TO THE FEMUR. LOOSE FEMORAL COMPONENT WITH CYSTIC FORMATION IN THE MEDIAL COMPARTMENT NOTED. REVISION TOTAL KNEE ARTHROPLASTY, FEMUR WITH A NEW 13 MM INSERT CONDUCTED. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY IN GOOD CONDITION. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Cyst(s); Discomfort; Joint effusion; Swelling/ Edema

  MAUDE report 21028533 ↗
• InjuryNov 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 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 20630847 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(6)). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 178 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. AT THE TIME OF LEGAL NOTIFICATION, A REVISION PROCEDURE HAD NOT BEEN PERFORMED. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

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

  MAUDE report 20548994 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431762 ↗
• InjurySep 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 83 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 20310803 ↗
• InjuryAug 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 150 MONTHS AFTER A TOTAL LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, SWELLING, EFFUSION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19975310 ↗
• InjuryJul 24, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  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 PROSTHESIS WEARJOINT PAIN; JOINT SWELLING AND STIFFNESS;LIMITED RANGE OF MOTION; LOSS OF MOBILITY; TISSUE DAMAGE; FRACTURE; REVISION SURGERY; INSTABILITY; OSTEOLYSIS; REVISION WITH BONE GRAFT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19820201 ↗
• InjuryJul 17, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6) + LEFT KNEE. (B)(6) IS ASSOCIATED WITH THIS CASE THE PATIENT HAS FILED A SHORT-FORM. COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-35-4011 - LOGIC TIBIA PS MOD INSRT SZ 4 11MM. SERIAL: (B)(6). 510K: K033883. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6) 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4; (B)(6) 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T; (B)(6) 200-02-35 - TH

  Patient problems: Adult Respiratory Distress Syndrome; Ambulation or Postural Difficulties; Emotional Changes; Osteolysis; Pain

  MAUDE report 19760569 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK DEVICE ON THE LEFT KNEE, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19618888 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT 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: Failure of Implant

  MAUDE report 19504417 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 72 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 19503450 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SORENESS AND PAIN. THE PATIENT EXPERIENCED FUNCTIONAL LIMITATIONS WITH SLEEPING, DESCENDING STAIRS, WALKING, SQUATTING, KNEELING. 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

  MAUDE report 19491911 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 140 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS. 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; Scar Tissue; Synovitis

  MAUDE report 19490790 ↗
• InjuryJun 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING AND INSTABILITY. THE SURGEON OBSERVED POLYETHYLENE WEAR, OSTEOLYSIS, AND GROSS LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REPLACED AND REVISED THE FEMORAL AND TIBIAL COMPONENTS. 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; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19479069 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, STIFFNESS, TISSUE DAMAGE, OSTEOLYSIS, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19472203 ↗
• InjuryMay 29, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A TOTAL JOINT 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 19419778 ↗
• InjuryMay 23, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  "EMAIL TO COMPLAINTS AWARE DATE 17MAY2024, PATIENT IS A VERIFIED RIGHT KNEE (B)(6) 2015 AND RIGHT KNEE REVISION ON (B)(6) 2023. (OP REPORT ATTACHED) PATIENT PRESENTS WITH COMPLAINTS OF PAIN AND INSTABILITY. PREOPERATIVE DIAGNOSIS : RIGHT KNEE FAILED TOTAL KNEE REPLACEMENT, RIGHT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT, RIGHT KNEE OSTEOLYSIS. POST OPERATIVE DIAGNOSIS: SAME. PROCEDURE NOTES INDICATE POLYETHYLENE LINER WAS REMOVED AND NOTED AS WEAR OF THE LINER WITH DELAMINATION. FEMORAL COMPONENT WAS LOOSE AND REMOVED. SOME OSTEOLYSIS BENEATH FIBROUS TISSUE BUT CONDYLES INTACT. NO EVIDENCE OF INFECTION. PATELLA IS NOTED TO BE WELL FIXED WITH SOME WEAR. SOME OSTEOLYSIS OF REMAINING PATELLA THAT WAS DEBRIDED. PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. WEIGHT BEARING AS TOLERATED.

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

  MAUDE report 19380790 ↗
• InjuryMar 27, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 12 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. THERE IS NO SPECIFIC DEVICE INFORMATION PROVIDED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 18985113 ↗

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