Optetrak Logic 02-012-35-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10885862001740), received between Oct 30, 2020 and May 21, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Naturally Worn” (25 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Unstable; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FILED A LEGAL FORM AND APPEARS TO BE ALLEGING PROSTHESIS WEAR OF THEIR POLYETHYLENE INSERT, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. THERE IS NO INFORMATION PROVIDED THAT THE PATIENT HAS BEEN REVISED.

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

  MAUDE report 25246184 ↗
• InjuryMay 6, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 13 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR. THE POLY WAS SWAPPED OUT FOR A 15MM PS INSERT. THE PATELLA WAS REVISED TO A COMPETITORS PATELLA. PHOTOS PROVIDED SHOW WEAR OF THE PATELLA. THE POLY DEBRIS FROM THE INSERT AND PATELLA WAS REMOVED AND WASHED OUT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21967658 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY 11 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT STATED THEY HAVE OSTEOLYSIS, REQUIRING A COMPLETE KNEE REVISION. THE PATIENT FURTHER STATED THAT THE MATERIAL ON THE PATELLA WAS NOT REMOVED DUE TO ITS THINNESS (DOCUMENTED IN ANOTHER EVENT), AND THEY ARE STILL EXPERIENCING EXTREME PAIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 21314652 ↗
• InjuryOct 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING AND PAIN, SYNOVITIS, OSTEOLYSIS, POLYETHYLENE WEAR OF THE INSERT, GROSSLY DEBONDED FEMORAL. 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; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20382618 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, STIFFNESS, PAIN AMBULATING, DIFFICULTY ASCENDING/DESCENDING STAIRS AND DIFFICULTY PERFORMING NORMAL DAILY PHYSICAL ACTIVITIES. 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; Pain; Swelling/ Edema

  MAUDE report 20245111 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 84 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL 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 effusion; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 20244936 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (B)(4). REFER TO (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AFFECTED MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. INITIAL EBI SURGERY NOT FOUND.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20177830 ↗
• InjuryAug 28, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 142 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND INSTABILITY. 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; Synovitis

  MAUDE report 20085762 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 148 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 20032331 ↗
• InjuryAug 15, 2024Naturally Worn; Naturally Worn

  THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED. BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19991345 ↗
• InjuryJul 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) OF 2019, WHO HAD AN INITIAL REVISION IN (B)(6) OF 2023 UNDERWENT A 2ND REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 1 YEAR 2 MONTHS POST THE MAY PROCEDURE DUE TO WEAR ON PATELLA AND TIBIAL INSERT. THE KNEE FORM DIAGNOSIS SECTION INDICATES TIBIAL INSERT WEAR AND PITTING. ALL DEVICES WERE REMOVED AND REPLACED WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THE INITIAL REVISION HAS BEEN REPORTED UNDER MDR #1038671-2023-01402.

  Patient problems: Insufficient Information

  MAUDE report 19838913 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 146 MONTHS AFTER A LEFT 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 19828779 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 74-YEAR-OLD PATIENT HAD A LEFT TKA ON (B)(6) 2014. THE PATIENT PRESENTED WITH INFLAMMATION / PAIN ON UNK-UNK-2016. IT WAS FURTHER STATED - SOFT TISSUE RETINACULUM INFLAMMATION GRADUAL ONSET APPROX. 2016. LEFT KNEE - LATERAL ASPECT PAIN. THE ACTION TAKEN IS OTHER - REVIEWED ON (B)(6) 2024. NOW RESOLVED. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2024. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Inflammation; Pain

  MAUDE report 19317046 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR POLYETHYLENE WEAR AND SEVERE OSTEOLYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19273948 ↗
• InjuryMay 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 64 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. THE REVISING SURGEON NOTED BONE DAMAGE AND CANCELLOUS BONE LOSS IN THE FEMORAL CONDYLE AND TIBIAL PLATEAU. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19242797 ↗
• InjuryMay 3, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, AND COMPONENT LOOSENING. 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: Failure of Implant; Implant Pain; Pain; Scar Tissue; Synovitis

  MAUDE report 19238816 ↗
• InjuryMar 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 18886097 ↗
• InjuryFeb 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON 01-MAR-2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Discomfort; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 18677454 ↗
• InjuryJan 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 4 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2023 DUE TO ACCELERATED AND PREVENTABLE WEAR. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18436036 ↗
• InjuryJan 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2018 DUE TO ACCELERATED AND PREVENTABLE WEAR. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18435665 ↗
• InjuryOct 4, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 10 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED POLYETHYLENE TIBIAL TRAY LINER. PATIENT HAD A CORONAL PLANE INSTABILITY. MEDIAL PARAPATELLAR ARTHROTOMY WAS CARRIED OUT IN LINE WITH PREVIOUS INCISION. PATELLA WAS EVERTED AND FOUND TO BE STABLE. POLYETHYLENE TIBIAL TRAY SPACER WAS REMOVED AND EXCESSIVE POSTERIOR WEAR ON THE POSTERIOR RUNNERS AS WELL AS AROUND THE POST WAS NOTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM OVERNIGHT FOR OBSERVATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 17869978 ↗
• InjuryAug 23, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY OF THE LEFT TOTAL KNEE ON (B)(6) 2023, APPROXIMATELY 4 YEARS, 5 MONTHS AFTER IMPLANT. THE PATIENT PRESENTED TO THE DOCTOR'S OFFICE WITH COMPLAINTS OF THEIR BILATERAL TOTAL KNEE REPLACEMENTS. UPON EXAMINATION, POLY WEAR AND OSTEOLYSIS WAS "EVIDENT". THE PATIENT UNDERWENT A POLY INSERT SWAP TO A PSC POLY. PHOTOS AND X-RAYS WERE OBTAINED. THE DEVICES WILL NOT BE RETURNED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Insufficient Information; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 17607649 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED POST-OP VIA CLINICAL STUDY THAT THE 53 YO FEMALE EXPERIENCE REFLEX SYMPATHETIC DYSTROPHY, CAUSING EXTREME HYPERSENSITIVITY FROM MID-THIGH TO FOOT. THE DATE OF EVENT ONSET IS UNK-UNK-2016. THE PATIENT WAS TREATED WITH MEDICATION AND REFERRED TO PAIN MANAGEMENT. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017.

  Patient problems: Complex regional pain syndrome; Pain

  MAUDE report 16869478 ↗
• InjuryApr 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2016. SHE HAD RIGHT KNEE REVISION (B)(6) 2023, APPROXIMATELY 6 YEARS 3 MONTHS AFTER THEIR INITIAL REPLACEMENT. POSTOPERATIVE DIAGNOSIS: RIGHT KNEE FAILED TOTAL KNEE REPLACEMENT RIGHT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT RIGHT KNEE OSTEOLYSIS. THERE WAS NOTED TO BE WEAR OF THE LINER WITH A SMALL REGION OF DELAMINATION. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. 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; Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 16838270 ↗
• InjuryApr 18, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  LEGAL CASE - USA. PATIENT ID: (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED RIGHT KNEE ON (B)(6) 2011, THEN HAD RIGHT KNEE REVISION (B)(6) 2023, APPROXIMATELY 12 YEARS AFTER THEIR INITIAL SURGERY. POST OPERATIVE REPORT STATES THAT THE PATELLA WAS FOUND TO BE LOOSE WITH CYSTIC CHANGES UNDERNEATH THE PATELLA. TIBIAL TRAY WAS REMOVED. THERE IS EXTENSIVE WEAR IN THE MEDIAL PLATEAU AND PROXIMALLY WITH TIBIAL POST WAS BROKEN. FEMORAL AND TIBIAL COMPONENTS WERE EXTENSIVELY EVALUATED THERE IS NO EVIDENCE OF LOOSENING OF EITHER COMPONENT. BECAUSE OF THIS WE ELECTED NOT TO REVISE THE FEMORAL AND TIBIAL COMPONENTS AS THERE WERE WELL FIXED. WOUND WAS CLOSED IN A LAYERED FASHION PATIENT WAS DISCHARGED RECOVERY KEPT OVERNIGHT FOR OBSERVATION. 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. EBI INITIAL SURGERY SEARCH - HSS - NO RESULTS 02-012-35-2013 - (B)(4) - LOGIC TIBIA PS MOD INSRT SZ 2 13MM. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16764812 ↗

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