Optetrak Logic 02-012-35-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10885862001924), received between Oct 19, 2020 and May 7, 2026 — classified as 89 injuries, 1 malfunction.

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

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0584-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

2. 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 8 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT MADE AN ALLEGATION AGAINST EXACTECH, BUT DOES NOT APPEAR TO HAVE BEEN REVISED. BECAUSE THE PATIENT HAS FILED A LEGAL CLAIM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25112130 ↗
• InjuryDec 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE SURGEON NEEDED TO PERFORM A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. THERE WAS MINIMAL OSTEOLYSIS PRESENT, BUT THE PATELLA EXHIBITED SEVERE WEAR ALONG LATERAL TRACKING PATH AND HAS DISASSOCIATED FROM BONE. THE TIBIAL INSERT HAD MILD WEAR ON THE MEDIAL AND LATERAL ARTICULAR SURFACES, AND POSTERIOR OF POST. THE FEMORAL AND TIBIAL COMPONENT WERE WELL FIXED. THE SURGEON DECIDED TO KEEP THE TIBIAL AND FEMORAL COMPONENTS RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 23704097 ↗
• InjurySep 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 138 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PERSISTENT EFFUSIONS, WEIGHTBEARING PAIN, A LOOSE FEMUR AND RECALLED POLY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRE-OP X-RAYS SHOWED LARGE EFFUSION AND OSTEOLYSIS AROUND THE PERIPHERY OF THE TIBIAL AND FEMORAL COMPONENTS. THE PATELLA WAS FOUND TO BE DELAMINATED WITH YELLOW OXIDATION. THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE. THE TIBIAL COMPONENT WAS WELL-FIXED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. IMAGES AND X-RAYS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint effusion; Osteolysis; Pain

  MAUDE report 22956451 ↗
• InjuryMay 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 78 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS FEMORAL LOOSENING. THE PATIENT EXPERIENCED JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, AND INTACT CEMENT MANTLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. X-RAY AND DEVICE PHOTO PROVIDED. NO DEVICE RETURNS ANTICIPATED. DUE TO THE RECALL, THE HOSPITAL WILL NOT RELEASE THE IMPLANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 22096924 ↗
• InjuryMay 14, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 115 MONTHS AFTER A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A PLANNED RIGHT KNEE REVISION PROCEDURE TO ADDRESS SIGNIFICANT PROSTHESIS WEAR. IT WAS REPORTED THE SURGEON OBSERVED BREAKAGE OF A DEVICE(S) AND FRAGMENTS; PARTS OR PIECES FELL INTO THE PATIENT. IT WAS REPORTED ALL THE FRAGMENTS AND PIECES WERE REMOVED AND RETRIEVED FROM THE PATIENT AND PATIENT WOUND SITE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS REVISED TO AN EXACTECH INSERT AND A COMPETITOR'S PATELLA. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS OF THE EXPLANTED INSERT AND PATELLA WERE PROVIDED. NO MEDICAL REPORTS OR OPERATIVE REPORTS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22022453 ↗
• InjuryMar 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 78 Y/O MALE PATIENT WAS REVISED DUE TO PAIN. PATIENT HAD LOOSE FEMUR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Aseptic loosening; Inadequate Osseointegration; Joint effusion; Pain; Synovitis

  MAUDE report 21673471 ↗
• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 110 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21549499 ↗
• InjuryMar 3, 2025Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 116 MONTHS AGO THE PATIENT UNDERWENT RIGHT KNEE TOTAL KNEE REPLACEMENT. THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. IT IS REPORTED THE PATIENT WILL REQUIRE A RIGHT KNEE REVISION SURGERY. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21503350 ↗
• InjuryJan 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 158 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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: Insufficient Information

  MAUDE report 21199726 ↗
• InjuryDec 27, 2024Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT A 56 Y/O MALE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2016. APPROXIMATELY 6 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO PAIN AND INCREASING EFFUSIONS. REVISION OP REPORT ((B)(6) 2022) THE POSTOPERATIVE DIAGNOSIS WAS A FAILED RIGHT KNEE ARTHROPLASTY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Pain

  MAUDE report 21025712 ↗
• InjuryNov 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LEFT KNEE PAIN AND STIFFNESS. 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." (B)(6)2024: ADDITIONAL INFORMATION RECEIVED. ADDED CONCOMITANTS. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-35-5009 - LOGIC TIBIA PS MOD INSRT SZ 5 9MM. SERIAL: (B)(6). 510K: K033883. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: YES. 21-MAY-2024 ADDITIONAL INFORMATION. LEGAL CASE ¿ USA (MDL NO. 3044). PATIENT ID: (B)(6) + LEFT KNEE. 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 RE

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Muscle Weakness/Atrophy; Pain; Synovitis

  MAUDE report 20677858 ↗
• InjuryNov 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). PATIENT ID: RICHARD B. BEASLEY + RIGHT KNEE. (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 141 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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: Discomfort; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20625259 ↗
• InjuryOct 21, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 179 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. 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 20499026 ↗
• InjuryOct 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 165 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR 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; Joint effusion; Pain

  MAUDE report 20472078 ↗
• InjurySep 26, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS; COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Osteolysis; Pain

  MAUDE report 20309276 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 53 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 20200852 ↗
• InjurySep 10, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - USA - MDL (3044). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 88 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, EFFUSION, INFLAMMATION, INSTABILITY, ANTALGIC GAIT, EMOTIONAL DISTRESS. 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; Emotional Changes; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue

  MAUDE report 20177965 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  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 20146489 ↗
• InjurySep 5, 2024Unstable; Naturally Worn; Lack of Effect; Unstable; Naturally Worn; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 66 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN, WEAKNESS, SWELLING, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY; REVISION SURGERY; MEDICAL CARE AND TREATMENT INCLUDING DIAGNOSTIC TESTING, THERAPY, AND PAIN MANAGEMENT; FUTURE MEDICAL CARE, GREAT PHYSICAL AND MENTAL PAIN; UNABLE TO PARTICIPATE IN ACTIVITIES IN WHICH HE ENGAGED PRIOR TO SURGERY . 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; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20144963 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  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 20001777 ↗
• InjuryAug 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING AND INSTABILITY. 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19961484 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 132 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARPAIN AND EFFECT ON HIS QUALITY OF LIFE AND FUNCTION, POLYETHYLENE WEAR, SIGNIFICANT OSTEOLYTIC DAMAGE, AND LOSS OF BONE. 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; Osteolysis; Pain

  MAUDE report 19906086 ↗
• InjuryJul 23, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND DECREASED RANGE OF MOTION; PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES; FUTURE DAMAGES INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, MENTAL AND EMOTIONAL STRESS, AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Emotional Changes; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19810901 ↗
• InjuryJul 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 124 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19791926 ↗
• InjuryJul 8, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, AND INSTABILITY. 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; Joint Laxity; Swelling/ Edema

  MAUDE report 19689428 ↗

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-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