Optetrak Logic 02-012-44-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10885862173478), received between Aug 7, 2020 and Mar 13, 2025 — classified as 49 injuries.

The most frequently reported specific device problem is “Naturally Worn” (29 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 107 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, DISCOMFORT, SWELLING, GAIT IMPAIRMENT, POOR BALANCE, AND LIMITED ACTIVITIES OF DAILY LIVING. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. AT THE TIME OF LEGAL NOTIFICATION, A REVISION PROCEDURE HAD NOT BEEN PERFORMED. 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; Pain; Swelling/ Edema

  MAUDE report 21599391 ↗
• InjuryJan 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 84 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR FAILED IMPLANT, SCAR TISSUE, AND SYNOVITIS. 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; Scar Tissue; Synovitis

  MAUDE report 21179301 ↗
• InjuryJan 16, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6) + RIGHT KNEE. (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 100 MONTHS AFTER A BILATERAL TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, BUCKLING OF RIGHT KNEE, AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES NOTED RIGHT KNEE POLYETHYLENE-ASSOCIATED SYNOVITIS. THE INSERT SHOWED SOME EVIDENCE OF POSTEROMEDIAL WEAR. THE FEMORAL COMPONENT AND TIBIAL COMPONENT WERE TESTED MANUALLY FOR STABILITY AND DID NOT DEMONSTRATE ANY INSTABILITY INTRA-OPERATIVELY. IT WAS ELECTED BY THE SURGEON TO PROCEED WITH A POLYETHYLENE INSERT EXCHANGE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Joint effusion; Pain; Synovitis

  MAUDE report 21167239 ↗
• InjuryJan 10, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 6 YEARS AND 1 MONTH 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 9 AUG 2023. DIAGNOSIS: ASEPTIC LOOSENING. AN EXTENSIVE SYNOVECTOMY OF THE MEDIAL GUTTER, LATERAL GUTTER, SUPRAPATELLAR POUCH, AND FAT PAD WAS PERFORMED. THE POLYETHYLENE INSERT WAS REMOVED. THERE WAS SOME BURNISHING BUT NO SIGNIFICANT GROSS WEAR OF THE INSERT AND NO SIGNIFICANT POST DAMAGE. THE FEMORAL COMPONENT WAS FOUND TO BE SIGNIFICANTLY LOOSE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. UNABLE TO LOCATE SURGEON/PATIENT/SERIAL NUMBER IN EBI. NO SERIAL NUMBERS AVAILABLE. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRA

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

  MAUDE report 21127172 ↗
• InjuryDec 26, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, JOINT LAXITY, PAIN, AND SWELLING/EDEMA.. INITIAL 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21020228 ↗
• InjuryOct 10, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS MASSIVE POLY WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INDICATION: ASEPTIC LOOSENING IN THE SETTING OF MASSIVE POLY WEAR FROM RECALLED IMPLANT. PROCEDURE DESCRIPTION: IT WAS NOTED THAT THERE WAS HYPERTROPHIC AND METALLIC APPEARANCE OF THE SYNOVIUM. AN EXAMINATION OF THE POLYETHYLENE LINER REVEALED CATASTROPHIC FAILURE OF THE MEDIAL COMPARTMENT LEADING TO METAL ON METAL ARTICULATION. RETRACTORS WERE PLACED AND THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. NEXT THE TIBIA WAS PRESENTED ANTERIORLY AND A THIN CURVED OSTEOTOME WAS USED TO REMOVE THE TIBIAL COMPONENT. THIS AGAIN WAS PERFORMED WITH MINIMAL DIFFICULTY AND MINIMAL BONE LOSS. THERE WAS A SIGNIFICANT CAVITARY LESION IN THE PATELLA THAT WAS DEBRIDED WITH A RONGEUR AND CURETTE. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology; Scar Tissue

  MAUDE report 20422903 ↗
• InjuryOct 9, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA: IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, EXTREME PAIN, CRACKS, SWELLING AND LOSS OF BALANCE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Balance Problems; Pain; Swelling/ Edema

  MAUDE report 20409652 ↗
• InjuryAug 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 82 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND 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: Joint Laxity; Osteolysis; Pain

  MAUDE report 20024825 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO FEMUR LOOSENING FROM POLY, AND PATELLA WEAR. 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.

  Patient problems: Insufficient Information

  MAUDE report 19806016 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 126 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SYNOVITIS, SCAR TISSUE AND DAMAGED SUPRAPATELLAR POUCH. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. ASSOCIATED CASE: (B)(4).

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

  MAUDE report 19497451 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR WITH SIGNS OF LOOSENING OF THE FEMUR AND TIBIA. PATIENT HAD LARGE OSTEOLYTIC DEFECT IN THE POSTEROMEDIAL TIBIA. POST OPERATIVE DIAGNOSIS NOTED DEGENERATIVE ARTHRITIS OF THE RIGHT KNEE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 19468217 ↗
• InjuryJun 4, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 111 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. IT WAS OBSERVED THAT THE POLYETHYLENE TIBIAL INSERT WAS ABNORMALLY WORN WITH DELAMINATION OF THE POLYETHYLENE AND THE PATIENT EXPERIENCED PAIN, SWELLING, AND INSTABILITY. 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; Implant Pain; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19464426 ↗
• InjuryJun 3, 2024Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 142 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, MECHANICAL LOOSENING, POLYETHYLENE WEAR, SYNOVITIS, OSTEOLYSIS, AND EFFUSION. 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 effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19454163 ↗
• InjuryMay 30, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 112 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR DESTRUCTION OF BONE, OSSEOUS RESORPTION, OSTEOLYSIS, SYNOVITIS, SWELLING, PAIN, LIMITED RANG EOF MOTION, DIFFICULTY WALKING, AND LOSS OF ENJOYMENT OF LIFE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. RIGHT KNEE ALSO OPERATED IN (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19425620 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MODERATE EFFUSION WITH SIGNIFICANT JOINT LAXITY, AND SYNOVITIS, 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; Joint Laxity; Joint effusion; Synovitis

  MAUDE report 19351691 ↗
• InjuryFeb 21, 2024Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS, 1 MONTH AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE. REVISED TO EXACTECH POSTERIOR STABILIZED SIZE 2, 13 PS POLY WITH BIOMET 3 PEG PATELLA. PATIENT WAS HAVING PERSISTENT PAIN, STIFFNESS AND SWELLING, SIGNS OF INSTABILITY, AND CHRONIC PAIN. UNRESURFACED KNEE. SYNOVECTOMY PREFORMED. REPLACED 9MM POLYETHYLENE WITH 13MM AND THIS ¿DRAMATICALLY¿ IMPROVED VARUS/VALGUS INSTABILITY. PATIENT WAS TAKEN TO PACU INSTABLE CONDITION, NO COMPLICATIONS. NO MENTION OF COMPONENT LOOSENING OR POLYETHYLENE WEAR. 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18746570 ↗
• InjuryFeb 21, 2024Naturally Worn; Osseointegration Problem; Naturally Worn; Osseointegration Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 10 YEARS AFTER INITIAL IMPLANT. POSTOPERATIVE DIAGNOSIS: 1. FAILED RIGHT TOTAL KNEE REPLACEMENT 2. RECALLED IMPLANT 3. PERIPROSTHETIC OSTEOLYSIS. REVISED TO COMPETITOR¿S DEVICES. CT SHOWED NO EVIDENCE OF LOOSENING OF THE FEMORAL COMPONENT BUT THERE WAS NOTED TO BE OSTEOLYSIS AROUND THE FEMORAL FLANGE. PATELLA SHOWED NO LOOSENING. FEMORAL COMPONENT SHOWED TO BE GROSSLY LOOSE. TIBIA NOTED TO BE WELL FIXED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION, THERE WERE NO COMPLICATIONS. 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: Joint Laxity; Osteolysis; Pain

  MAUDE report 18746523 ↗
• InjuryFeb 16, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 18721261 ↗
• InjuryFeb 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 6 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18721178 ↗
• InjuryDec 19, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP INITIAL LEFT TKA, THIS 50 Y/O FEMALE PATIENT WAS REVISED. REVISED DO TO RECALL, FEMORAL AND LINER REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - LAWYER RECALL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18360212 ↗
• InjuryAug 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY ON (B)(6) 2014 AND THEN APPROXIMATELY 6 YEARS, 7 MONTHS LATER EXPERIENCED A REVISION SURGERY ON (B)(6) 2021. IT IS ALSO STATED -PATIENT'S OPTETRAK TKA SYSTEM FAILED AND REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE IMPLANT AND REPLACE IT WITH ANOTHER JOINT REPLACEMENT SYSTEM. BECAUSE SHE REQUIRED AN ADDITIONAL REVISION SURGERY, SHE HAS SUFFERED SIGNIFICANT AND CONTINUING PERSONAL INJURIES, IS LIMITED IN HER ACTIVITIES OF DAILY LIVING AND REQUIRES ADDITIONAL PHYSICAL THERAPY. 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. 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 PREMATUR

  Patient problems: Damage to Ligament(s); Implant Pain; Osteolysis; Pain

  MAUDE report 17597893 ↗
• InjuryJul 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2016 . THEY SUBSEQUENTLY HAD LEFT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 7 YEARS 2 MONTHS AFTER THEIR PRIMARY SURGERY. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: LEFT TOTAL KNEE ASEPTIC LOOSENING. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND MARKED OSTEOLYSIS. THERE WAS NOTED TO BE VERY EXTENSIVE SYNOVITIS AND WEAR OF THE LINER WITH DELAMINATION. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE, AND IT WAS REMOVED. THERE WAS 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 THAT WAS DEBRIDED. 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.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 17266478 ↗
• 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 RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019 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; Discomfort; Insufficient Information; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 17009300 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A REVISION OP REPORT, THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT TOTAL KNEE IMPLANTED WITH A LOGIC TIBIA INSERT ON (B)(6) 2015, UNDERWENT A RIGHT REVISION TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SEEN BY THE SURGEON IN THE OFFICE WITH A FAILED RIGHT TOTAL KNEE REPLACEMENT REFRACTORY TO CONSERVATIVE MANAGEMENT. IMAGING WAS CONSISTENT WITH FAILED RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS INDICATED FOR SURGERY. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16758702 ↗
• InjuryApr 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 6.5 YEARS POST INITIAL LEFT TKA, THE 70 Y/O FEMALE PATIENT WAS EVALUATED IN CLINIC AND FOUND TO HAVE ASEPTIC LOOSENING OF HER LEFT KNEE. SHE WAS INDICATED FOR LEFT REVISION TOTAL KNEE ARTHROPLASTY. PATIENT'S FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND REMOVED USING A TAMP AND MALLET. PATIENT WAS REVISED TO COMPETITORS DEVICES. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO RECOVERY UNIT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Joint Laxity; Scar Tissue; Synovitis

  MAUDE report 16696871 ↗