Optetrak Logic 02-012-44-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10885862173560), received between Aug 11, 2020 and May 12, 2025 — classified as 42 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA, IT WAS REPORTED THAT APPROXIMATELY 50 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, ASEPTIC LOOSENING OF PATELLA. 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. UNABLE TO CONFIRM DEVICE SERIAL NUMBER DUE TO MULTIPLE PATIENTS LISTED ON EBI INVOICE DATA.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 22002292 ↗
• InjuryApr 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND BONE FRACTURE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND CONFIRMED THAT THERE WAS BONDING OF THE TIBIAL IMPLANT AT THE KEEL, BUT WAS NOT FIXED AT THE LEVEL OF THE TIBIAL RESECTION. EVIDENCE OF STRESS SHIELDING WAS NOTICED. REVISION IMPLANTS WERE PLACED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 21902553 ↗
• InjuryNov 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, FIBROSIS, DISCOMFORT, PAIN, LOSS OF RANGE OF MOTIONS AND SYNOVITIS. 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: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 20693610 ↗
• InjuryNov 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 131 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 20687858 ↗
• InjuryAug 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE 66 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS POST OP. PATIENT HAD FALLEN AND WAS HAVING PAIN WITH KNEE. THE 11MM SIZE 3 LINER AND 32MM PATELLA WERE REMOVED AND WHILE INSPECTING THE PROSTHESIS THE FEMORAL COMPONENT HAD BECOME LOOSE. THE SURGEON RECEMENTED A NEW FEMORAL COMPONENT AND IMPLANTED AN 11MM PSC SIZE 3 IMPLANT AND 35MM PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Fall

  MAUDE report 19940398 ↗
• InjuryJul 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 4 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SUFFERING FROM LAXITY, INSTABILITY, AND CHRONIC HYDRARTHROSIS. MACROSCOPIC PE GRANULOMA INDICATED. THE REPORT STATED THE PATIENT HAD ASEPTIC TIBIAL AND FEMORAL LOOSENING 5 YEARS AFTER THE INITIAL PLACEMENT. THE PE WAS CHANGED. NO SURGICAL DELAYS OR DEVICE BREAKAGES WERE REPORTED. NO X-RAYS WERE PROVIDED. THE DEVICE RETURN STATUS FOR ANALYSIS IS UNKNOWN CURRENTLY. THEY HAVE BEEN REQUESTED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Granuloma; Joint Laxity; Joint effusion

  MAUDE report 19802056 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A PAINFUL, SEPTIC RIGHT KNEE WITH ACUTE HEMATOLOGIC INFECTION. 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; Arthritis; Implant Pain; Pain; Sepsis

  MAUDE report 19713321 ↗
• InjuryJun 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  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, REVISION SURGERY, OSTEOLYSIS, SYNOVITIS, POLYETHYLENE WEAR, BONE GRAFTING, INSTABILITY, LOSS OF MOBILITY, SWELLING, PAIN. 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; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19618114 ↗
• InjuryJun 6, 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 41 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, LIMITED ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE; FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO 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. 13592, 13594 IS ASSOCIATED WITH THIS CASE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Implant Pain; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 19476067 ↗
• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL COMPONENT LOOSENING, LINER DELAMINATION AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED.

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

  MAUDE report 19454357 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL SHORT FORM THAT AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY NEED A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19263603 ↗
• 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 136 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND ASCEPTIC LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED FAILURE OF TOTAL KNEE ARTHROPLASTY RIGHT KNEE SECONDARY TO ASCEPTIC LOOSENING WITH RECALLED EXACTECH TOTAL KNEE IMPLANTS. 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; Insufficient Information

  MAUDE report 19238168 ↗
• InjuryApr 16, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 4 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SUFFERING FROM LAXITY, INSTABILITY, AND CHRONIC HYDROARTHROSIS. MACROSCOPIC PE GRANULOMA INDICATED. THE REPORT STATED THE PATIENT HAD ASEPTIC TIBIAL AND FEMORAL LOOSENING 5 YEARS AFTER THE INITIAL PLACEMENT. THE PE WAS CHANGED. NO SURGICAL DELAYS OR DEVICE BREAKAGES WERE REPORTED. NO X-RAYS WERE PROVIDED. THE DEVICE RETURN STATUS FOR ANALYSIS IS UNKNOWN CURRENTLY. THEY HAVE BEEN REQUESTED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

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

  MAUDE report 19122445 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19086029 ↗
• InjuryMar 25, 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 A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 8 YEAR AND 6 MONTHS AFTER INITIAL IMPLANT. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18967623 ↗
• InjuryJan 10, 2024Naturally 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)2018. 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 SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 18486164 ↗
• InjurySep 15, 2023Naturally 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 THE PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, THEN APPROXIMATELY 8 YEARS, 7 MONTHS LATER, ON (B)(6) 2022 WAS SURGICALLY REVISED. REVISION OPERATIVE REPORT OF (B)(6) 2022: FAILED LEFT TOTAL KNEE REPLACEMENT. REVISION OF TIBIAL AND FEMORAL IMPLANTS. FINDINGS: SEVERE AMOUNT OF DISTAL FEMORAL AND POSTERIOR LATERAL PROXIMAL TIBIAL BONE LOSS. SEVERE AMOUNT OF POLY WEAR PRESENT ON THE POLYETHYLENE-THERE WAS A WALNUT SIZE AREA OF PROXIMAL BONE LOSS DUE TO OSTEOLYSIS ALONG THE PROXIMAL POSTERIOR TIBIAL -BASE PLATE WAS GROSSLY LOOSE. ALONG THE POSTERIOR DISTAL FEMUR AND THE ANTERIOR LATERAL FEMORAL IMPLANT THERE WAS SEVERE BONE LOSS AS A RESULT OF OSTEOLYSIS. SOFT TISSUE THROUGHOUT THE KNEE JOINT HAD SIGNS OF SEVERE OSTEOLYSIS AS WELL. GROSSLY LOSE FEMORAL AND TIBIAL IMPLANTS- REMOVED EASILY WITH MINIMAL BONE LOSS. REVISED TO COMPETITOR¿S DEVICES. THE PATIENT WAS SENT TO PACU INSTABLE CONDITION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. 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 OTHER INFORMATION IS AVAILAB

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 17756770 ↗
• InjurySep 12, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Lack of Effect; Unstable; Naturally Worn; Insufficient Device Problem Information; Lack of Effect

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY (B)(6) 2018. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 4 YEARS 8 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC LEFT KNEE JOINT. THERE WAS SIGNIFICANT EFFUSION AND SYNOVITIS, AND THERE WAS DELAMINATION OF THE POLYETHYLENE BUT NO EVIDENCE OF PROSTHESIS LOOSENING. THE SURGEON FURTHER NOTED THAT THERE WAS DEBONDING OF THE FEMORAL COMPONENT FROM THE CEMENT. THE PATELLA WAS LEFT IN PLACE BECAUSE IT WAS INTACT AND WELL FIXED. 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: Discomfort; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Synovitis

  MAUDE report 17732780 ↗
• InjuryAug 4, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6)2014. THEY UNDERWENT RIGHT KNEE REVISION ON (B)(6)2023, APPROXIMATELY 8 YEARS 4 MONTHS POST PRIMARY PROCEDURE. THE PATIENT HAS CLAIMED INJURIES INCLUDING BUT NOT LIMITED TO PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED. 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; Breast Discomfort/Pain; Discomfort; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 17465639 ↗
• InjuryAug 2, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 9 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: RIGHT KNEE POLYETHYLENE WEAR, OSTEOLYSIS, LOOSENING FEMORAL COMPONENT AND INSTABILITY. FINDINGS: NO GROSS EVIDENCE OF INFECTION. GLOBAL INSTABILITY. SYNOVITIS CONSISTENT WITH LOOSENING FEMORAL COMPONENT AND POLY WEAR. POLY WEAR WORSE INVOLVING THE POST. OSTEOLYSIS FEMUR AORI 2B WORSE AT PERIPHERY OF COMPONENT AND POSTERIOR CONDYLES. AORI 2A LAT BONE LOSS. UNDERMINING OSTEOLYSIS PATELLA WITH POLY WEAR.

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

  MAUDE report 17443518 ↗
• InjuryJul 25, 2023Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 11 YEAR 2 MONTHS POST PRIMARY PROCEDURE. PREOPERATIVELY, PATIENT PRESENTED WITH PAINFUL AND UNSTABLE LEFT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND MARKED OSTEOLYSIS. SURGEON NOTED THERE WAS WEAR OF THE POLYETHYLENE LINER WITH DELAMINATION. THE FEMORAL COMPONENT WAS NOTED AS LOOSE WITH SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT THERE WAS SOME WEAR ON THE PATELLA. THERE WAS SOME OSTEOLYSIS OF THE REMAINING PATELLA THE WAS DEBRIDED. 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; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17389959 ↗
• InjuryJul 12, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 9 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT 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 LEFT TOTAL KNEE REPLACEMENT. MODERATE FEMORAL BONE LOSS - DID NOT REQUIRE CONE. EXTENSIVE TIBIAL BONE LOSS WITH A POSTERIOR FRACTURE. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THIS WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PSEUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. THE SURGEON EXAMINED THE POLYETHYLENE - EXCESSIVE WEAR WAS PRESENT WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRED PLACEMENT OF A TIBIAL CONE. FINDINGS: LOOSE FEMORAL AND TIBIAL IMPLANTS. PATIENT WAS SENT TO PACU IN STABLE CONDITIO

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

  MAUDE report 17309582 ↗
• InjuryMay 26, 2023Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information; Mechanical Problem; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2011. APPROXIMATELY 11 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, INSTABILITY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS. 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; Arthralgia; Insufficient Information; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 17009517 ↗
• InjuryMay 19, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. THEY WERE SCHEDULED FOR RIGHT KNEE REVISION (B)(6) 2023, APPROXIMATELY 6 YEARS 10 MONTHS AFTER THEIR INITIAL PROCEDURE. 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: Insufficient Information; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16961417 ↗
• InjuryApr 28, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  REVISION OPERATIVE REPORT ON (B)(6) 2023: POSTOPERATIVE DIAGNOSIS: LEFT KNEE FAILED TOTAL KNEE REPLACEMENT WITH RECALLED EXACTECH POLYETHYLENE; SYNOVITIS SECONDARY TO POLYETHYLENE WEAR; INSTABILITY. CLINICAL HISTORY: THE PATIENT PRESENTS WITH AN EXACTECH LEFT KNEE REPLACEMENT WITH A RECALL ON THE POLYETHYLENE LINER FOR PREMATURE WEAR. THE PATIENT PRESENTED TO THE OFFICE WITH AN EFFUSION AND SOME PAIN AS WELL AS SOME INSTABILITY. A PREOPERATIVE MRI DEMONSTRATED SYNOVITIS SECONDARY TO POLYETHYLENE WEAR, BUT THE COMPONENTS WERE WELL FIXED. REVISION LEFT TOTAL KNEE REPLACEMENT WITH A DEBRIDEMENT, POLYETHYLENE LINER EXCHANGE, AND A PATELLA REVISION. EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT PERFORMED. POLY LINER WAS REMOVED. THERE WAS NOTED TO BE SOME WEAR OF THE LINER. FEMORAL COMPONENT NOTED TO BE WELL FIXED. THERE WAS NO INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT THERE WAS WEAR ON THE PATELLA WITH SOFT TISSUE AND BONE OVERGROWTH. TIBIAL WAS NOTED TO BE WELL FIXED. A FULL DEBRIDEMENT OF THE KNEE POSTERIORLY WAS PERFORMED TO REMOVE THE SYNOVITIS POSTERIORLY. THE PATIENT WAS TRANSFERRED TO THE

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Joint effusion; Pain; Synovitis

  MAUDE report 16832353 ↗