Optetrak Logic 02-010-01-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885862001238), received between Dec 11, 2019 and Aug 4, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (25 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: Pain

  MAUDE report 50127348 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 74 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, POLYETHYLENE WEAR, BONE GRAFTING, INSTABILITY, LOSS OF MOBILITY, SWELLING, PAIN. ADDITIONALLY FEMORAL KNEE DEBONDING/LOOSENING AND ACUTE PAIN OF THEIR RIGHT KNEE WAS REPORTED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 23640914 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT UNDERWENT PRIMARY RIGHT KNEE REPLACEMENT SURGERYDUE TO ARTHRITIS. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY APPROXIMATELY 7 YEARS 6 MONTHS AFTER THEIR INITIAL IMPLANTATION. FEMORAL KNEE DEBONDING/LOOSENING WAS REPORTED. OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED TOTAL KNEE REPLACEMENT; OSTEOLYSIS WITH ASEPTIC LOOSENING; INSTABILITY WITH HYPEREXTENSION; ARTERIAL BRANCH INJURY WITH REPAIR. THE SURGEON NOTED THAT "INTERESTINGLY, THERE WERE DISTAL AUGMENTS ON THE PRIMARY FEMORAL COMPONENT THAT WAS REMOVED WHICH INDICATED THAT HE MAY HAVE HAD A RECURVATUM DEFORMITY PRIOR TO THE INDEX KNEE REPLACEMENT AND THAT THE SURGEON WAS TRYING TO TIGHTEN THE EXTENSION GAP." 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. THIS IS 1 OF 3 REPORTS FOR THIS INCIDENT.

  Patient problems: Aseptic loosening; Osteolysis; Unspecified Tissue Injury

  MAUDE report 23639731 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED KNEE PAIN. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 12 YEARS AFTER INITIAL IMPLANTATION. IT WAS LATER OBSERVED THAT THE PATIENT'S FEMORAL COMPONENT HAD DEBONDED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23631933 ↗
• InjuryNov 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE AROUND THE INTERNAL PROSTHETIC KNEE JOINT AND FEMORAL LOOSENING/DEBONDING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Periprosthetic fracture

  MAUDE report 23610218 ↗
• InjuryFeb 24, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 77 MONTHS AFTER A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED PAIN AND INSTABILITY AND UNDERWENT A RIGHT KNEE REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED RIGHT KNEE FAILED KNEE REPLACEMENT, RIGHT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT AND RIGHT KNEE OSTEOLYSIS. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT SYNOVITIS AND WEAR OF THE LINER. IT WAS NOTED THE FEMORAL COMPONENT WAS LOOSE AND THE SURGEON OBSERVED FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. IT WAS NOTED THERE WAS NO EVIDENCE OF INFECTION. THE PATELLA WAS NOTED TO BE WELL FIXED BUT WITH SOME WEAR. THERE WERE NO SURGICAL OR MEDICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Extraskeletal ossification; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21446664 ↗
• InjuryJan 24, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  PER INFORMATION RECEIVED BY THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER FIRST REPLACE THE PATIENT HAD A REVISION ON (B)(6) 2022. PATIENT EXPERIENCED OSTEOLYSIS, PAIN AND FAILURE OF IMPLANT. SEVERE POLY WEAR ALONG THE MEDIAL AND LATERAL SURFACE WITH A BROKEN PORTION OF THE PS POST TIP AS WELL. GROSSLY LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MINIMAL BONE LOSS. MASSIVE DISTAL FEMORAL MEDIAL AND LATERAL CONDYLE BONE LOSS - MEDIAL CONDYLE WAS SO DAMAGED THERE WAS A FRACTURE PRESENT THAT REQUIRED TWO SCREW FIXATION. 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. REVISED TO ANOTHER COMPANY'S DEVICES. PATIENT SENT TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 21233336 ↗
• InjuryJan 22, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). PATIENT ID: RIGHT KNEE. 9/23/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/16/24. ATTACHED EMAIL AND LEGAL SHORT FORM. 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. AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2010. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 12 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT THE KNEE WAS GROSSLY UNSTABLE IN ALL PLANES THROUGH THE RANGE OF MOTION. THE SYNOVIUM WAS B

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21211652 ↗
• InjuryJan 16, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  "LEGAL CASE ¿ USA . PATIENT ID: + LEFT KNEE. IT WAS REPORTED THAT APPROXIMATELY 90 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, JOINT LAXITY, OSTEOLYSIS, SWELLING/EDEMA, PAIN 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: Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21170992 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR AND POLY WEAR/FAILURE OF THE RECALLED INSERT. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21066104 ↗
• InjuryDec 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, MUSCLE WEAKNESS, PAIN, SCAR TISSUE, OSTEOLYSIS, 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: Loss of Range of Motion; Muscle Weakness/Atrophy; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20917997 ↗
• InjuryDec 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 20914692 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, OSTEOLYSIS, SYNOVITIS, AND 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 20905460 ↗
• InjuryNov 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 128 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PROSTHESIS WEAR, PERIPROSTHETIC OSTEOLYSIS AND LOOSENING. A REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, THE SURGEON OBSERVED NOTABLE REACTIVE SYNOVITIS AND JOINT EFFUSION. IT WAS NOTED THERE WAS NO EVIDENCE OF INFECTION. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED ON INSPECTION BUT WAS EASILY REMOVED AND DEBONDED WITH OSTEOLYTIC DEFECTS INVOLVING THE MEDIAL AND LATERAL FEMORAL CONDYLES. THE PATELLAR BUTTON WAS NOTED TO HAVE SIGNIFICANT WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20621216 ↗
• InjuryOct 14, 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) 2019 APPROXIMATELY 3 YEARS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED RIGHT KNEE FAILED TOTAL KNEE REPLACEMENT. CLINICAL HISTORY: THE PATIENT PRESENTS WITH A PAINFUL AND UNSTABLE RIGHT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE FEMORAL COMPONENT WITH COLLAPSE INTO VARUS. DESCRIPTION OF PROCEDURE: AN EXTENSIVE SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED AND IT WAS INSPECTED. IT WAS NOTED TO HAVE SCRATCHING AND BURNISHING. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH OSTEOLYSIS AND A LOT OF BONE LOSS OF THE MEDIAL FEMORAL CONDYLE. THE PATELLA HAD MINIMAL WEAR AND IT WAS LEFT IN PLACE. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 20447498 ↗
• InjurySep 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MASTER CASE NO. 2022 CA 002670) PATIENT ID: PAMELA SILVIS-ZELASKO + RIGHT KNEE CASE-(B)(4) RK 2ND REV IS ASSOCIATED WITH THIS CASE. 9/18/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/13/24. ATTACHED EMAIL, INITIAL AND REVISION OP REPORTS/PRODUCT IDS, AND EBI REPORT. ADDED DEVICE INFORMATION FOR FEMORAL IN CASE AND UPDATED DEVICE INFORMATION IN CASE-(B)(4) BASED ON NEW INFORMATION RECEIVED. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 53 MONTHS AFTER A RIGHT KNEE REVISION PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN AND WEAKNESS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED RIGHT FAILED TOTAL KNEE ARTHROPLASTY. INDICATIONS FOR PROCEDURE: THE PATIENT IS AN 63 Y.O. FEMALE WHO HAD A RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED AT AN OUTSIDE HOSPITAL IN THE DISTANT PAST. SHE HAD A HISTORY OF PRIOR REVISION WITH POLY EXCHANGE WITH ME IN 2017 THAT WORKED WELL FOR SEVERAL YEARS WITH THE EXACTECH OPTETRAK KNEE SYSTEM WITH A POLYETHYLENE THAT WAS ULTIMATELY RECALLED BY THE COMPANY. SHE PRESENTED TO MY OFFICE AT SHANDS IN 2022, WITH A CHIEF COMPLAINT OF CONTINUED

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

  MAUDE report 20268078 ↗
• InjurySep 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM, SEVERE OSTEOLYSIS ON FEMUR AND MODERATE ON TIBIA, SEVERE WEAR OF TIBIAL INSERT, GROSSLY LOOSE FEMORAL, PARTIALLY LOOSE TIBIAL TRAY . 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; Synovitis

  MAUDE report 20241425 ↗
• InjurySep 17, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. 3044) PATIENT ID: (B)(6) + RIGHT KNEE . 9/16/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/11/24. ATTACHED EMAIL, INITIAL OP REPORT/PRODUCT ID, AND REVISION OP REPORT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRINCIPAL DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO POLYETHYLENE WEAR AND LOOSENING. HISTORY OF PRESENT ILLNESS: (B)(6) IS A 63 Y.O. FEMALE WITH A REMOTE HISTORY OF A RIGHT TOTAL KNEE REPLACEMENT. PATIENT BEGAN HAVING SYMPTOMS OF RIGHT KNEE PAIN. PATIENT HAS A KNOWN IMPLANT WHICH DOES HAVE A RECALL SECONDARY TO POLYETHYLENE WEAR AND LOOSENING. THE PATIENT HAD PAIN WITH SIGNS AND SYMPTOMS OF LOOSENING. SHE SAW HER PRIMARY SURGEON WHO RECOMMENDED REVISION. WITH THAT IN MIND A HAD A 2ND OPINION WITH ME REGARDING THE PAIN THAT SHE WAS HAVING. PATIENT HAD PLAIN X-RAY FINDINGS CONCERNING FOR LOOSENING OF THE FEMORAL COMPONENT WITH SOME EVIDENCE OF EARLY POLYETHYLENE WEAR AN IMPLANT THAT WAS ONLY A FEW YEARS OLD. THEN MIND IT WAS FELT THE PATIENT HAD ASEPTIC LOOSENING SECONDARY TO POLYETHYLENE WEAR GIVEN THE NATURE OF THE IMPLANT. SPECIFICS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO POLYETHYLENE WEAR AND LOOSENING. ENCOUNTERING STRAW

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20239577 ↗
• InjurySep 11, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018. APPROXIMATELY 3 YEARS AND 7 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PROSTHESIS WEAR, SYNOVITIS, JOINT LAXITY, OSTEOLYSIS, METAL RELATED PATHOLOGY, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 20197287 ↗
• InjuryAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2024, APPROXIMATELY 9 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 20042474 ↗
• InjuryJun 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 63 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISSOLUTION OF POLY LINER, EXTENSIVE OSTEOLYSIS, BONE LOSS, DISCOMFORT, HYPERTROPHIC SYNOVIUM, EXTENSIVE POLY DELAMINATION AND FRACTURING, AND 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; Discomfort; Failure of Implant; Osteolysis; Synovitis

  MAUDE report 19566201 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 168 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS, MEDIAL FEMORAL CONDYLE FRACTURE AND BONE LOSS. 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; Failure of Implant; Osteolysis

  MAUDE report 19500147 ↗
• InjuryJul 5, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; 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)2015 AND THEN APPROXIMATELY 8 YEARS, 2 MONTHS LATER THEY EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6)2023-POSTOPERATIVE DIAGNOSIS: RIGHT FAILED TOTAL KNEE ARTHROPLASTY. INDICATION: 87 Y.O. FEMALE WHO WAS SEEN IN THE OFFICE WITH A FAILED RIGHT TOTAL KNEE REPLACEMENT REFRACTORY TO CONSERVATIVE MANAGEMENT. IMAGING WAS CONSISTENT WITH FAILED RIGHT KNEE ARTHROPLASTY. PROCEDURE: A THOROUGH SYNOVECTOMY WAS PERFORMED. REMOVAL OF IMPLANTS. THE POLYETHYLENE INSERT WAS REMOVED WITH A THIN BENT RETRACTOR. THE FEMORAL COMPONENT WAS REMOVED BY HAND. ATTENTION WAS THEN TURNED TO THE TIBIA; USING THE SMALL SAW AND OSTEOTOMES, THE TIBIA WAS REMOVED WITH MINIMAL BONE LOSS. THE PATELLA WAS DEBRIDED OF SCAR TISSUE AND THE BUTTON WAS REMOVED WITH A SAW. IMPLANTS WERE TRIALED AND NEW DEVICES IMPLANTED. DRESSINGS WERE APPLIED. 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 OTH

  Patient problems: Aseptic loosening; Failure of Implant; Insufficient Information; Synovitis

  MAUDE report 17258979 ↗
• InjuryApr 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2011. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY ON (B)(6) 2023. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16812387 ↗
• InjuryFeb 24, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  STUDY: EXACTECH KNEE REPLACEMENT STUDY; SUBJECT: (B)(6). IT WAS REPORTED VIA CLINICAL STUDY THAT THE 70 YO FEMALE PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2021 DUE TO A LOW PERIPROSTHETIC FRACTURE TO RIGHT TOTAL KNEE REPLACEMENT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED (B)(6) 2021. THERE WAS NO CASE REPORT FORM INFORMATION PROVIDED.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 16437075 ↗

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