Optetrak Logic 02-012-35-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885862001825), received between Aug 11, 2020 and Dec 9, 2024 — classified as 39 injuries.

The most frequently reported specific device problem is “Naturally Worn” (31 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  APPROXIMATELY 5 YEAR(S), 5 MONTH(S) AND 17 DAY(S) POST-OPERATIVE OF A LEFT TKA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. REDUCTION IN BEND OF LEFT KNEE WITH NOTICEABLE EFFUSION WITHIN JOINT. THE PATIENT UNDERWENT LEFT KNEE ARTHROSCOPY, DEBRIDEMENT, & BIOPSY OF THEIR LEFT KNEE AS A DAY CASE. PATIENT IS STILL STRUGGLING WITH THEIR KNEE, EFFUSION REMAINS & REDUCED FLEXION. LISTED FOR REPLACEMENT OF POLYETHENE INSERT +/- REVISION. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. REPORTED CONCOMITANT DEVICE(S): 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T.

  Patient problems: Joint effusion; Loss of Range of Motion

  MAUDE report 20885992 ↗
• InjuryDec 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 110 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836526 ↗
• InjuryOct 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 99 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382464 ↗
• InjuryAug 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Synovitis

  MAUDE report 20087938 ↗
• InjuryAug 19, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 28 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: Ambulation or Postural Difficulties; Insufficient Information; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 20000335 ↗
• InjuryAug 19, 2024Collapse; Unstable; Naturally Worn; Collapse; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 150 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, LOOSENING, DEBONDING, AORI TYPE 2B BONE LOSS. 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; Osteolysis; Synovitis

  MAUDE report 20000150 ↗
• InjuryAug 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 163 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: Insufficient Information

  MAUDE report 20000019 ↗
• InjuryJul 26, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  LEGAL CASE ¿ USA BULK LEGAL EMAIL (440). (B)(4) LK REV#2 IS ASSOCIATED WITH THIS CASE. (B)(4) LK REV #3 IS ALSO ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 23 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR UNKNOWN ISSUES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 19844536 ↗
• InjuryJul 24, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WHERE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES, INCLUDING BUT NOT LIMITED TO SEVERE PAIN, SCARRING, SWELLING, EFFUSION, ANTALGIC GAIT, INFLAMMATION, KNEE POPPING AND CRACKING, INSTABILITY, AND OTHER INJURIES WHICH HAVE RESULTED IN PAST AND FUTURE MEDICAL EXPENSES, SURGERY, PAST AND FUTURE LOST EARNINGS AND EARNING CAPACITY, ANXIETY, EMOTIONAL DISTRESS AND GENERAL DAMAGES.. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Emotional Changes; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19821105 ↗
• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 121 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 19770591 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 146 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PERIPROSTHETIC 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: Failure of Implant; Osteolysis

  MAUDE report 19488051 ↗
• InjuryJun 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 141 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ANTERIOR KNEE PAIN, INSTABILITY IN THE KNEE WITH VARUS-VALGUS STRESS AND HYPEREXTENSION, WORN AND UNDERSIZED PATELLAR COMPONENT, EVERTED PATELLA, AND MILD WEAR ON THE TIBIAL INSERT WITH SOME FISSURING AND CRACKING NOTED. 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: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19479671 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  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: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 19327099 ↗
• InjuryApr 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT HAS A PLANNED KNEE ARTHROPLASTY REVISION SCHEDULED FOR (B)(6) 2024 BY (B)(6). RECORDS SEARCH LOCATED AN INITIAL SURGERY FOR (B)(6) BY(B)(6) ON (B)(6) 2014. COMPONENTS IMPLANTED ARE LISTED BELOW AND ATTACHED. AT THE TIME OF LEGAL NOTIFICATION: 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 RETURNED, THERE ARE NO PHOTOS, RADIOGRAPHS OR OTHER IMAGES OF THE DEVICE PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19125693 ↗
• InjuryApr 15, 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 REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 10 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. PREOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING, OSTEOLYSIS, POLY WEAR. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. .

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

  MAUDE report 19103223 ↗
• InjuryApr 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. THE PATIENT HAS NOT BEEN SURGICALLY REVISED. THERE IS NO OTHER PATIENT OR MEDICAL INFORMATION PROVIDED. THERE ARE NO IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PROVIDED/ SEARCHABLE INFORMATION DOES NOT CLARIFY THE LEG IN WHICH THE DEVICE WAS ACTUALLY IMPLANTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19029839 ↗
• InjuryMar 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023 APPROXIMATELY 11 YEARS AND 3 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: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 18985115 ↗
• InjuryMar 20, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18938699 ↗
• InjuryJan 9, 2024Mechanical Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA EXACTECH KNEE REPLACEMENT STUDY, THAT A 66 YO MALE PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2016, DUE TO OSTEOARTHRITIS, WAS REVISED ON (B)(6) 2023, APPROXIMATELY 7 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT HAD REDUCTION IN BENDING THE LEFT KNEE WITH NOTICEABLE EFFUSION WITHIN THE JOINT. DATE OF ONSET, (B)(6) 2022. POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS WAS INDICATED, AND AN ARTHROSCOPIC WASH OUT WAS PERFORMED ON (B)(6) 2022. ON (B)(6) 2023, A LEFT TKR WAS PERFORMED, AND THE POLY WAS EXCHANGED. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND TO PROCEDURE. THE OUTCOME INDICATES THE EVENT WAS RESOLVED ON THE REVISION DATE. NO DEVICE RETURNS ANTICIPATED DUE TO THE CLINICAL STUDY GUIDELINES. NO FURTHER INFORMATION.

  Patient problems: Joint effusion; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 18478412 ↗
• InjuryDec 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL LEFT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED. THE PATIENT WAS REVISED DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT CAUSING THE SURGEON TO SPEND 5-15 MINUTES REMOVING THEM. THE PATIENT WAS REVISED TO A 35MM PATELLA AND A SIZE 3 13MM TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING - DISCARDED AT HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18420372 ↗
• InjuryDec 4, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2010. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A 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.

  Patient problems: Discomfort; Failure of Implant; Insufficient Information; Muscle Weakness/Atrophy; Pain

  MAUDE report 18255079 ↗
• InjurySep 18, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 7 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS EXPERIENCED PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: ASEPTIC LOOSENING LEFT TOTAL KNEE FINDINGS: GROSS LOOSENING OF THE FEMORAL COMPONENT, PATELLAR COMPONENT AND EARLY LOOSENING TIBIAL COMPONENT. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTI-DISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTI-DISTRICT 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) O

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Insufficient Information; Joint effusion

  MAUDE report 17765496 ↗
• InjurySep 18, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA EXACTECH KNEE REPLACEMENT STUDY, THIS 49 Y/O FEMALE PATIENT WAS EXPERIENCING A SUDDEN ONSET OF PAIN AND INSTABILITY OF LEFT KNEE REPLACEMENT IN EARLY APRIL. SINCE THEN KNEE FELT LIKE IT HYPEREXTENDS AND SHE CANNOT GO UP AND DOWN STAIRS WITHOUT FEELING LIKE HER LEG IS GOING TO GIVE WAY. BY EXAMINATION SHE HAS NEGATIVE 8 DEGREES OF EXTENSION AND GREATER THAN 14 DEGREES OF VALGUS LAXITY. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 17765429 ↗
• InjurySep 11, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL SURGERY ON (B)(6) 2016. THE PATIENT PRESENTED ON (B)(6) 2023 AND PATIENT HAS EFFUSION AND POLYETHYLENE WEAR WITH EVIDENCE OF OSTEOLYSIS RESULTING IN A LEFT REVISION TOTAL KNEE REPLACEMENT POLY EXCHANGE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis

  MAUDE report 17719433 ↗
• InjuryAug 1, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED EXPLANTED DEVICES FROM THE FIELD. NO FURTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17439135 ↗

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