Optetrak Logic 02-012-44-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10885862173645), received between Aug 10, 2020 and Dec 29, 2025 — classified as 44 injuries.

The most frequently reported specific device problem is “Naturally Worn” (32 reports).

1 FDA recall record name this device's identifier, 1 still open.

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

• InjuryDec 29, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 9 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PREVIOUSLY RECEIVED DIRECT IMPACT TRAUMA TO THE AFFECTED KNEE, WHICH MAY HAVE AFFECTED PATELLA TRACKING. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MINIMAL OSTEOLYSIS WAS PRESENT. THE SURGEON REMOVED ALL OSTEOLYTIC TISSUE. THE PATELLA SHOWED MILD WEAR ALONG THE LATERAL TRACKING PATH. THE TIBIAL INSERT HAD MINIMAL WEAR. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE TIBIAL AND FEMORAL COMPONENTS WERE RETAINED WHILE THE PATELLA AND TIBIAL INSERT COMPONENTS WERE REPLACED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23906020 ↗
• InjuryJun 11, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRELIMINARY AND POSTOPERATIVE DIAGNOSE INDICATED LOOSE LEFT TOTAL KNEE REPLACEMENT. FINDINGS INDICATED A LARGE AMOUNT OF GRAY SYNOVITIS, OSTEOLYSIS, AND NO EVIDENCE OF INFECTION. TIBIA, FEMUR, AND PATELLA WERE REMOVED, THERE WAS NO CEMENT ON THE FEMORAL SIDE OF THE PROSTHESIS OR ON THE TIBIAL SIDE OF THE PROSTHESIS OR ON THE PATELLA. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 22186245 ↗
• InjuryFeb 13, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA THE LEGAL LONG FORM: PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY WHERE HE WAS IMPLANTED WITH A RECALLED OPTETRAK POLYETHYLENE TIBIAL INSERTS PATIENT'S RIGHT KNEE CONTINUES TO BE MONITORED AND HE MAY REQUIRE REVISION SURGERY ON HIS RIGHT KNEE AT A LATER DATE TO REMOVE THE RECALLED LINER. 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 (B)(6). 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: Insufficient Information

  MAUDE report 21375268 ↗
• InjuryJan 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 102 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISCOMFORT, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, FAILED IMPLANT AND IMPLANT 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 21183741 ↗
• InjuryDec 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 97 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN, SYNOVITIS, OSTEOLYSIS, AND CYST(S). 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; Cyst(s); Osteolysis; Pain; Synovitis

  MAUDE report 21047068 ↗
• InjuryAug 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED 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: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19931892 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 127 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING PAIN, DIFFICULTY AMBULATING, ASEPTIC LOOSENING. OSTEOLYSIS, . 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; Osteolysis; Pain

  MAUDE report 19826393 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 127 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING PAIN, DIFFICULTY AMBULATING, ASEPTIC LOOSENING. OSTEOLYSIS, . 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; Osteolysis; Pain

  MAUDE report 19826337 ↗
• InjuryJul 22, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. 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; Discomfort; Implant Pain; Joint effusion; Muscle Weakness/Atrophy; Osteolysis; Pain; Synovitis

  MAUDE report 19795753 ↗
• InjuryJul 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 32 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, WEAKNESS, NEGATIVELY IMPACTED MOBILITY AND QUALITY OF LIFE; REVISION SURGERY WITH RESULTANT PERIOD OF PAIN FOLLOWING SURGERY, RECUPERATION, REHABILITATION, AND PHYSICAL THERAPY; LIMITED ABILITY TO PERFORM PHYSICAL ACTIVITIES SUCH AS WALKING AND STANDING. 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; Implant Pain

  MAUDE report 19700648 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN. THE REASON FOR THE LEFT KNEE REVISION WAS STATED TO BE FOR "LOOSE FEMUR AND BAD POLY". THE PATIENT HAD A REVISION SURGERY APPROXIMATELY 7 YEARS, 4 MONTHS POST IMPLANT. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF A DEVICE, OR SURGICAL DELAY/PROLONGATION THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19606050 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 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 19504989 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 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 19313694 ↗
• InjuryMay 3, 2024Naturally 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 POLYETHYLENE WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED MECHANICAL LOOSENING OF LEFT KNEE INTERNAL PROSTHESIS. 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; Discomfort; Failure of Implant; Pain; Synovitis

  MAUDE report 19238274 ↗
• InjuryMar 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18872907 ↗
• InjuryMar 6, 2024Flaked; Peeled/Delaminated; Naturally Worn; Flaked; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT A 82 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR AS WELL AS FLAKING AND DELAMINATION. THE PATIENT WAS REVISED TO A 38MM PATELLA, AND THE TIBIAL INSERT WAS REVISED TO A SZ 4, 11MM. FRAGMENTS OF POLYETHYLENE WERE PRESENT IN THE KNEE JOINT WHICH THE SURGEON REMOVED. X-RAYS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THE SURGEON KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18853045 ↗
• InjuryMar 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT DUE TO EXTENSIVE OSTEOLYSIS AND LARGE CYST FORMATION OF THE MEDIAL FEMORAL CONDYLE AND 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 effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18815128 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2015 AND THEN APPROXIMATELY 7 YEARS, 6 MONTHS LATER ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ARTHROSCOPIC PROCEDURE. ARTHROSCOPIC PROCEDURE OPERATIVE REPORT OF (B)(6) 2022- POSTOPERATIVE DIAGNOSIS ¿ DEBRIS SYNOVITIS STATUS POST LEFT TOTAL KNEE REPLACEMENT. NAME OF OPERATION: 1. ARTHROSCOPY 2. DEBRIDEMENT. 3. REMOVAL SCAR TISSUE 4. SYNOVECTOMY LEFT KNEE. THE PATIENT HAD SIGNIFICANT DEBRIS SYNOVITIS. THERE WAS NO LOOSENING OF THE PROSTHESIS, FEMUR, TIBIA, OR PATELLA. NO INTRAOPERATIVE COMPLICATIONS. THERE WERE NO RADIOGRAPHIC OR OTHER IMAGES PROVIDED. THERE WAS NO REVISION OF DEVICES. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 18651160 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. 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.

  Patient problems: Insufficient Information

  MAUDE report 18320882 ↗
• InjuryOct 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2017. THE REVISION WAS BOOKED BECAUSE OF THE PRODUCT RECALL. THE FEMUR WAS LOOSE AND THE TIBIA WAS WELL FIXED. THE POLY HAD A HIGH AMOUNT OF WEAR AND THERE WAS PRESENCE OF GRANULOMA. THE SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH A COMPETITOR'S REVISION KNEE. 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

  MAUDE report 18027229 ↗
• InjuryOct 20, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT TKA, THE 71 Y/O MALE PATIENT HAD A FULL REVISION SURGERY. PATIENT EXPERIENCED LAXITY, PAINFUL SYNOVITIS AND EXTENSIVE GRANULOMA REQUESTING EXCISION. PATIENT'S PE TIBIAL AND PATELLA IMPLANTS PRESENTED EXCESSIVE EARLY WEAR. PATIENT WAS REVISED TO COMPETITOR'S DEVICES. NO FURTHER INFORMATION PROVIDED. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES WILL BE RETURN.

  Patient problems: Failure of Implant; Granuloma; Joint Laxity; Synovitis

  MAUDE report 17981107 ↗
• InjuryOct 12, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 84 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED. PATIENT HAD A PAINFUL KNEE WITH MEDIAL TIBIAL INSERT WEAR AND FEMORAL LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 17920677 ↗
• InjurySep 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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) 2023. DIAGNOSIS: FAILED RIGHT KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE FINDINGS: AT SURGERY, THEY DID FIND SCRATCHING AND LOSS OF SURFACE FROM THE TIBIAL INSERT, ESPECIALLY ALONG THE POSTEROLATERAL MARGIN. THERE WAS NO GROSS DELAMINATION.

  Patient problems: Discomfort; Failure of Implant; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17689622 ↗
• InjuryAug 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2018 DUE TO PSORIATIC ARTHRITIS WITH VARUS DEFORMITY. THEY WERE SUBSEQUENTLY REVISED (B)(6) 2022, APPROXIMATELY 3 YEARS 6 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: CATASTROPHIC FAILURE OF LEFT TOTAL KNEE ARTHROPLASTY WITH MASSIVE OSTEOLYSIS. THE SURGEON NOTED THERE WAS DAMAGE TO THE POLYETHYLENE INSERT WITH BOTH DELAMINATION OF THE POLYETHYLENE AS WELL AS FRACTURE OF THE POLYETHYLENE. THERE WAS MARKED LYSIS SECONDARY TO THIS. A GROSSLY LOOSE FEMORAL COMPONENT WAS DEBONDED FROM THE CEMENT MANTLE. THERE WERE LARGE DEFECTS IN THE POSTERIOR ASPECT OF THE FEMUR ON THE MEDIAL SIDE AS WELL AS THE LATERAL SIDE SECONDARY TO LYSIS. THERE WERE LYTIC LESIONS IN THE TIBIAL PLATEAU MEDIALLY WHICH WERE CONTAINED AS WELL AS LATERALLY POSTERIORLY. ALL COMPONENTS WERE REMOVED. 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: Osteolysis

  MAUDE report 17663050 ↗
• InjuryJul 5, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2020. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 2 YEARS 10 MONTHS AFTER THEIR INITIAL IMPLANTATION. (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE. PATIENT HAD SEVERE SYNOVIAL EXPANSION WITH THE APPEARANCE OF FOREIGN BODY REACTION-TYPE TISSUE, AND THE POLYETHYLENE INSERT SHOWED PITTING WEAR ON ALL SURFACES. THERE WAS NO GROSS DELAMINATION, BUT THERE WAS SEVERE PITTING AND LOSS OF SURFACE SUBSTANCE, BOTH MEDIAL AND LATERALLY ON THE INSERT. THE PATIENT WAS AWAKENED AND TAKEN 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.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17261939 ↗