Optetrak Logic 02-010-01-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10885862001214), received between Oct 29, 2019 and Feb 25, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (37 reports).

3 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Loss of Osseointegration

  AS REPORTED, THIS MALE PATIENT HAD A RIGHT TKA. RADIOGRAPHS APPEARED SATISFACTORY; HE WAS NOT SEEN AGAIN UNTIL THESE DAYS BECAUSE HE WAS FINE BUT NOW, HE IS IN A LOT OF PAIN AND HIS KNEE IS DEFORMED. THE X-RAYS ARE IN FAVOR OF AN EXTENSIVE GRANULOMA SECONDARY TO ACCELERATED WEAR OF THE POLYETHYLENE (THIS PATIENT IS ON THE LIST OF THOSE WHO RECEIVED A POLYETHYLENE THAT HAD REMAINED ON THE SHELF FOR MORE THAN FIVE YEARS). THIS GRANULOMA SEEMS TO HAVE DESTROYED A GOOD PART OF THE LOWER FEMUR AND LOOSENED THE FEMORAL COMPONENT, AT LEAST, OF THE PROSTHESIS. SUBSEQUENTLY THE PATIENT WAS REVISED. PATIENT HAD STARTED TO FEEL PAIN IN HIS RIGHT LEG BUT HE THOUGHT THAT IT WAS NORMAL SINCE IT WAS THE FIRST TIME HAVING AN INSERT AND HE DIDN'T KNOW THAT HE WAS SUPPOSED TO WALK "PROPERLY". HE HAD TROUBLE WALKING AND BECAUSE OF THAT WE HAVE ASKED FOR AN EARLIER RETIREMENT BECAUSE HE COULDN'T WORK ANYMORE AND THANKFULLY IT WAS ACCEPTED. A FEW MONTHS BEFORE THE REVISION, HIS KNEE WAS SO SWOLLEN THAT IT HAS DOUBLED THE SIZE AND WE SOON REALIZE THAT MAYBE IT WAS BECAUSE SOMETHING WAS WRONG WITH THE INSERT. MY FATHER HAS SPENT YEARS WITH THIS BROKEN INSERT THAT HAS CAUSED HIM SO MUCH PAIN AND PREVENT H

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Granuloma; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 24444175 ↗
• InjuryNov 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FEMORAL KNEE DEBONDING/LOOSENING AND MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23627622 ↗
• InjuryNov 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT HAD AN INFECTION AND FEMORAL DEBONDING/LOOSENING. PER FOLLOW UP TO THE REPRESENTATIVE, THERE WERE NO MARKS ON THE TRAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 23598251 ↗
• InjuryNov 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AND 10 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. IT WAS LATER REPORTED THAT THE PATIENT'S FEMORAL COMPONENT WAS FOUND TO BE DEBONDED. 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 23597297 ↗
• InjuryMay 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED APPROXIMATELY 175 MONTHS POST A RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN AND APPROXIMATELY A WEEK LATER UNDERWENT SCHEDULED A SECOND RIGHT KNEE REVISION PROCEDURE OF THE FEMORAL COMPONENT INSERT AND PATELLA COMPONENTS. IT WAS NOTED THE INSERT AND PATELLA WERE REPLACED DUE TO RECALLS AND THE FEMORAL COMPONENT WAS SIGNIFICANTLY LOOSE. PICTURES OF THE EXPLANTS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR MEDICAL INTERVENTIONS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Joint Laxity; Pain

  MAUDE report 22009376 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 13 YEARS AND 7 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A LINER AND PATELLA EXCHANGE. THE PATIENT'S MAIN COMPLAINT WAS DISCOMFORT AND PAIN AROUND THE PATELLA. EXCHANGE OF THE TIBIAL LINER WAS MORE BECAUSE THE SURGEON WAS IN THERE. THERE WAS NO SIGN OF OSTEOLYSIS. 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: Discomfort; Limb Fracture; Pain

  MAUDE report 21675880 ↗
• InjuryMar 12, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 29 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE PATIENT HAS EXPERIENCED, JOINT PAIN, INSTABILITY/BALANCE ISSUES, SWELLING, RIGHT KNEE PAIN WITH SUBSIDENCE AND LOOSENING OF TIBIAL COMPONENT AND METALLOSIS. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Balance Problems; Implant Pain; Inflammation; Joint Laxity; Metal Related Pathology; Swelling/ Edema

  MAUDE report 21584950 ↗
• InjuryMar 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN OPTETRAK LOGIC CC TIBIAL INSERT. PATIENT WILL UNDERGO REVISION SURGERY ON (B)(6) 2023. FOLLOWING THE REVISION SURGERY, PATIENT WILL CONTINUE TO BE LIMITED IN HER ACTIVITIES OF DAILY LIVING. PATIENT HAS DIFFICULTY WITH DAILY ACTIVITIES SUCH AS GETTING DRESSED, CLIMBING STAIRS, AND BATHING. DESPITE UNDERGOING THE REVISION SURGERY, PATIENT WILL LIKELY EXPERIENCE DAILY PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Cyst(s); Discomfort; Pain; Synovitis

  MAUDE report 21550885 ↗
• InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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. PER THE AVAILABLE INFORMATION, IT ALSO APPEARS THAT THE PATIENT IS ALLEGING FEMORAL LOOSENING. COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION AND NO IMAGES AND RADIOGRAPHS WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 21404893 ↗
• InjuryFeb 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 80 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, LIGAMENT DAMAGE, IMPLANT PAIN, AND OSTEOLYSIS. 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: Damage to Ligament(s); Implant Pain; Osteolysis

  MAUDE report 21324819 ↗
• InjuryJan 6, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATION FEBRUARY 2023, THAT A PATIENT UNDERWENT INITIAL RIGHT TKR ON (B)(6) 2017 AND WAS IMPLANTED WITH EXACTECH DEVICES IN THE RIGHT KNEE. THE ARTHROPLASTY WAS DONE CORRECTLY AND DID NOT DEVIATE FROM ACCEPTED MEDICAL CUSTOM AND PRACTICE WITH REGARDS TO THE IMPLANTATION OF THE EXACTECH DEVICES. ON OR AROUND ON (B)(6) 2022, PATIENT RECEIVED A LETTER INFORMING OF DEVICES RECALLED BY EXACTECH. AFTER AN MRI WAS PERFORMED ON RIGHT KNEE, PATIENT WAS ADVISED THAT THE KNEE REPLACEMENT FAILED FOR REASONS RELATED TO THE DEFECTIVE DEVICE. AS A RESULT, THE PATIENT UNDERWENT REVISION SURGERY ON RIGHT KNEE ON (B)(6) 2022, APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, AND/OR COMPONENT LOOSENING. PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. FURTHER REPORTED ON (B)(6) 2024, THE PATIENT PRESENTS WITH A PAINFUL AND UNSTABLE RIGHT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND MARKED OSTEOLYSIS. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT INCLUDING ACT

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Inadequate Osseointegration; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 21086195 ↗
• InjuryJan 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, JOINT EFFUSION, PAIN, SCAR TISSUE, OSTEOLYSIS, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21078971 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 113 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, DETACHMENT OF DEVICE, OSTEOLYSIS, BONE FRACTURE(S), IMPLANT PAIN, DISCOMFORT, JOINT LAXITY AND SWELLING/ EDEMA. 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: Bone Fracture(s); Discomfort; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 21066694 ↗
• InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT APPROXIMATELY 37 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, FIBROSIS, IMPLANT PAIN, AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Implant Pain; Osteolysis

  MAUDE report 21036523 ↗
• InjuryDec 11, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  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; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 20907997 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 112 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, SYNOVITIS, OSTEOLYSIS, 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. 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: Failure of Implant; Implant Pain; Osteolysis; Synovitis

  MAUDE report 20906970 ↗
• InjuryDec 9, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS, 2 MONTHS AFTER INITIAL IMPLANT. PATIENT EXPERIENCED PROSTHESIS WEAR, LOOSENING, OSTEOLYSIS, SYNOVITIS, JOINT LAXITY, FAILURE OF IMPLANT AND IMPLANT PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. 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; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20882045 ↗
• InjuryDec 4, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 12 YEARS, 5 MONTHS AFTER INITIAL IMPLANT. THE PATIENT HAS EXPERIENCED SYNOVITIS, JOINT LAXITY, OSTEOLYSIS AND IMPLANT PAIN. REVISION OPERATIVE REPORT OF 15-AUG-2023- POSTOPERATIVE DIAGNOSIS: RIGHT KNEE FAILED TOTAL KNEE REPLACEMENT. RIGHT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT. RIGHT KNEE OSTEOLYSIS. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE WEAR OF THE LINER WITH DELAMINATION. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 20847186 ↗
• InjuryNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS AND 11 MONTHS LATER WAS REVISED ON (B)(6) 2023. THE PATIENT HAS EXPERIENCED POLYETHYLENE PROSTHESIS WEAR, PAIN, COMPONENT LOOSENING, OSTEOLYSIS, SCAR TISSUE AND DEVICE FAILURE. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. PER THE OPERATIVE REPORT FOR REVISION, DESCRIPTION OF THE INITIAL SURGERY COMPONENTS WERE PROVIDED AND THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE FOR THE CEMENT MANTLE AND THERE WAS A MODERATE AMOUNT OF OSTEOLYSIS BEHIND THE CEMENT MANTLE. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED TO BONE AND THE PATELLAR COMPONENT WAS WELL FIXED. THERE WAS A MODERATE AMOUNT OF VISIBLE AND PALPABLE POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Scar Tissue

  MAUDE report 20786856 ↗
• InjuryNov 26, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 73 MONTHS AFTER INITIAL IMPLANT. THE PATIENT EXPERIENCED INFLAMMATION, AMBULATION OR POSTURAL DIFFICULTIES, JOINT EFFUSION, SWELLING/EDEMA, SCAR TISSUE, JOINT LAXITY, OSTEOLYSIS AND PAIN. 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; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20786621 ↗
• InjuryOct 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8.5 YEARS POST INITIAL RIGHT TKA, THE 72 Y/O FEMALE PATIENT HAD A REVISION DUE TO RECALL TIBIA LINER AND LOOSEN FEMUR. PATIENT WAS REVISED TO A CONSTRAINED SIZE 2, RIGHT FEMUR 16 X 80 STEM WITH AN H 32 SMALL CONE AND A SIZE 9 TIBIAL INSERT CC. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 20513631 ↗
• InjuryOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. (B)(6) ) (NGG) (MMH). PATIENT ID: (B)(6). CASE NO:(B)(4). IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, SWELLING, INSTABILITY, AND ASEPTIC LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER 1764947 IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-35-2013 - LOGIC TIBIA PS MOD INSRT SZ 2 13MM. SERIAL: (B)(6), 510K: K033883, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6), 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ 2F / 3T. (B)(6), 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2. (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 201-78-11 - HOLDING PIN SMALL HEADED SHORT 4 PACK.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20498078 ↗
• InjurySep 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 168 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND DISCOMFORT, SWELLING, GAIT IMPAIRMENT, POOR BALANCE, AND COMPONENT PART LOOSENING. 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; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20291400 ↗
• InjurySep 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 75 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: Cyst(s); Joint effusion; Synovitis

  MAUDE report 20136489 ↗
• InjurySep 4, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  **28-AUG-2024 ADDITIONAL INFORMATION** LEGAL CASE ¿ (B)(4). PATIENT ID:(B)(6), (B)(4), LEFT KNEE IS ASSOCIATED WITH THIS CASE. IT IS REPORTED VIA LEGAL DOCUMENTATION (SHORT FORM COMPLAINT ATTACHED) THAT PLAINTIFF UNDERWENT RIGHT KNEE REVISION (B)(6) 2023. 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 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T SERIAL: (B)(6) 510K: K101981 UDI: (B)(4). PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO CONCOMITANT D

  Patient problems: Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20133925 ↗

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-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• 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