Optetrak Logic 02-010-01-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862001153), received between Jun 8, 2021 and Jul 28, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (23 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Report #2 of 2 for this event.It was reported this patient underwent a left total knee arthroplasty. Subsequently, four (4) years, nine (9) months later, the patient was revised to a competitor's construct due to prosthesis wear of the polyethylene component and loosening of the femoral component. A revision operative report was provided. Intraoperatively, the patella component was noted to be well fixed. The femoral component was easily removed without much bone loss. Osteolysis was observed in the tibia. After trialing new components, an anterior cortical fracture was observed. This required 2 cables to be placed. After this there is no fracture gapping. The patient was revised to a competitor's construct. The patient was awoken from anesthesia and transferred to the recovery room in stable condition. Additionally, it is reported via legal documentation, the patient has and continues to experience pain and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, bone loss and other injuries presently undiagnosed. No additional information is available.

  Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain; Periprosthetic fracture

  MAUDE report 50063037 ↗
• InjuryApr 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED JOINT EFFUSION, OSTEOLYSIS AND ASEPTIC LOOSENING. AS A RESULT, APPROXIMATELY SIX YEARS AND NINE MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT "THE INITIAL IMPRESSION WAS THAT THE IMPLANTS WERE FIXED, BUT THEY CAME OFF THE DISTAL FEMUR & PROXIMAL TIBIA WITHOUT MUCH EFFORT. THIS PATIENT HAD SEVERE OSTEOLYSIS OF THE BONE. THIS IS PARTICULARLY WEAR DEBRIS OSTEOLYSIS BECAUSE OF FAILURE OF THE MEDIAL ASPECT OF THE TIBIAL INSERT THAT THE POSTERIOR ASPECT OF THE MEDIAL PORTION OF THE TIBIAL INSERT WAS FRACTURED AND MORSELIZED. THE INSERT, HOWEVER, REMAINED WELL FIXED. THERE WAS NO EVIDENCE OF INFECTION. THERE WAS NO FRACTURE." PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Aseptic loosening; Joint effusion; Osteolysis

  MAUDE report 24875480 ↗
• InjuryJul 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP THE INITIAL LEFT TKA, THIS 59 Y/O PATIENT WAS REVISED DUE TO PAIN AND WEAR. PATIENT HAD A RECALLED IMPLANT. THE MEDIAL ASPECT OF THE JOINT SPACE SEEMED SLIGHTLY THINNER THAN THE LATERAL ASPECT INDICATING WEAR. THE FEMUR DEBONDED FROM THE CEMENT MANTLE. THE POLY SHOWED SIGNS OF DEGRADATION AND WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. DEVICES ARE NOT RETURNING; THE HOSPITAL DOES NOT ALLOW FOR THE RETURN OF EXPLANTS. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THERE WERE NO BROKEN INSTRUMENTS. THIS WAS AN IMPLANT ISSUE.

  Patient problems: Pain

  MAUDE report 22467533 ↗
• InjuryMar 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 8 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS JOINT LAXITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 21551913 ↗
• InjuryMar 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis; Synovitis

  MAUDE report 21551825 ↗
• InjuryMar 5, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 135 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-44-3511 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM, SERIAL: (B)(6), 510K: K110547, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES: SERIAL # ITEM # AND DESCRIPTION, (B)(6), 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 21528179 ↗
• InjuryFeb 12, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 126 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, AMBULATION DIFFICULTIES, IMPLANT PAIN, JOINT LAXITY, 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Scar Tissue; Synovitis

  MAUDE report 21367708 ↗
• InjuryJan 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, JOINT EFFUSION, OSTEOLYSIS, PAIN, AND SYNOVITIS. 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: Failure of Implant; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 21285053 ↗
• InjuryJan 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 105 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND ASEPTIC LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC, LEFT KNEE JOINT. INTRAOPERATIVELY THE SURGEON OBSERVED THE FEMORAL COMPONENT TO BE SIGNIFICANTLY LOOSE. A LATERAL DEFECT WAS NOTED DISTALLY AND POSTERIORLY AND NOTED BY THE SURGEON TO BE CONSISTENT WITH PREOPERATIVE RADIOGRAPHS. SCAR TISSUE WAS OBSERVED AROUND THE TIBIAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue

  MAUDE report 21157428 ↗
• InjuryJan 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  *ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 21-JUL-2023* IMPLANTATION PRODUCT (LEFT): ¿ OPTETRAK LOGIC TIBIAL INSERT (02-012-35-3509, (B)(6)) ¿ OPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED (02-010-01-0235, (B)(6)) ¿ OPTETRAK LOGIC FIT TIBIAL TRAY (02-012-45-3535, (B)(6)) ¿ OPTETRAK 3 PEG PATELLA (200-02-32, (B)(6)) DATE OF SURGERY: (B)(6) 2014 SURGEON: (B)(6) MD PLACE: (B)(6) SPECIFICS: ¿ BILATERAL DEGENERATIVE JOINT DISEASE ¿ BILATERAL TKA REVISION PRODUCT: ¿ ZIMMER FEMORAL AND TIBIAL COMPONENTS DATE OF SURGERY: (B)(6) 2022 SURGEON: (B)(6) MD PLACE: (B)(6) SPECIFICS: ¿ REVISION LEFT TKR ¿ EXTENSIVE POLY WEAR WITH LOOSENING OF HARDWARE ¿ SIGNIFICANT AMOUNT OF POLYETHYLENE DEBRIS AND PALE TANNISH BROWN TISSUE LOOSELY FLOATING IN KNEE. FEMORAL COMPONENT GROSSLY LOOSE. SIGNIFICANT AMOUNT OF FIBRIN IN FEMUR. DEBRIS FOUND UNDER MEDIAL TIBIAL BASE PLATE *ORIGINAL DESCRIPTION SUMMARY* LEGAL CASE - LK IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL BILATERAL KNEE IMPLANTED ON (B)(6) 2014, WHO WAS IMPLANTED WITH OPTETRAK DEVICES, INCLUDING OPTETRAK LOGIC TIBIAL INSERTS, SIZE 3.5, 9 MM MADE OF POLYETHYLENE, UNDERWENT A LEFT KNEE REVISION PROCEDURE ON (B)(6)

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 21080679 ↗
• InjuryDec 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 148 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PROGRESSIVE KNEE PAIN, OSTEOLYSIS, ASEPTIC LOOSENING OF FEMUR AND TIBIAL TRAY, POLYETHYLENE WEAR OF INSERT, SURFACE DAMAGE, DELAMINATION AND PITTING ON THE PATELLA, WHICH WAS FRACTURED AND LOOSE. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT DEVICES: (B)(6)- 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5. (B)(6)- 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T. 1429318 - 200-02-26 - THREE PEG PATELLA 26MM.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20879152 ↗
• 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 THAT APPROXIMATELY 128 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS COMPONENT LOOSENING. THE PATIENT WAS PRESENTED WITH SIGNIFICANT PERIPROSTHETIC OSTEOLYSIS AND ASEPTIC LOOSENING OF THEIR LEFT TOTAL KNEE ARTHROPLASTY WITH ASSOCIATED PAIN REFRACTORY TO COMPREHENSIVE NONOPERATIVE MANAGEMENT IN THE SETTING OF A RECALLED EXACTECH TOTAL KNEE DEVICE. THE PATIENT HAS EXPERIENCED FAILURE OF IMPLANT, IMPLANT PAIN, SYNOVITIS, SWELLING/ EDEMA, LOSS OF RANGE OF MOTION AND JOINT LAXITY. DURING THE PROCEDURE THERE WAS NOTED SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION CONSISTENT WITH POLYETHYLENE WEAR AND COMPONENT LOOSENING. THE FEMORAL COMPONENT WAS GROSSLY LOOSE WITH COMPLETE DE-BONDING AND NO EVIDENCE OF AN IMPLANT-CEMENT INTERFACE. UPON REMOVAL OF THE CEMENT THERE WERE SEVERE CONTAINED OSTEOLYTIC DEFECTS INVOLVING THE BILATERAL FEMORAL CONDYLES. THE PATELLAR BUTTON WAS INSPECTED AND DETERMINED TO BE LOOSE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FUR

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

  MAUDE report 20878842 ↗
• InjuryNov 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AMBULATION OR POSTURAL DIFFICULTIES, AND FAILURE OF IMPLANT. 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; Failure of Implant; Pain

  MAUDE report 20759465 ↗
• InjurySep 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 79 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 10 MONTHS POST OP. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT + THE FEMUR ¿DEBONDED¿ FROM THE CEMENT. DIAGNOSIS: LOOSENING, LYSIS OSTEO, TIBIAL & PATELLA WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Osteolysis

  MAUDE report 20176961 ↗
• InjurySep 5, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 146 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, PROGRESSIVE DEBILITATION, EFFUSION, DEBONDED FEMUR, POLYETHYLENE WEAR WITH DELAMINATION AND PITTING IN THE TIBIAL INSERT, SIGNIFICANT POLY WEAR ON THE PATELLA. 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; Joint Laxity; Joint effusion; Pain

  MAUDE report 20144585 ↗
• InjuryAug 27, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY AND OSTEOLYSIS. 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; Joint Laxity; Muscle/Tendon Damage; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20077845 ↗
• InjuryAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Osteolysis; Pain

  MAUDE report 20040472 ↗
• InjuryAug 22, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 156 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY; SIGNIFICANT SYNOVITIS, GROSS LOOSENING OF THE FEMUR. 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; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20037099 ↗
• InjuryAug 15, 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 APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, INSTABILITY, POLYETHYLENE WEAR, OSTEOLYSIS, CASE COMPLEXITY MODIFIER. 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; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19995922 ↗
• InjuryJun 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT AND THEN APPROXIMATELY 8 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION. REVISION OPERATIVE REPORT -COMPLICATIONS: INTEROP TIBIA FRACTURE DURING EXTRACTION OF TIBIAL COMPONENT [SN (B)(6), 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F/3.5T] REPORTED IN MFR # 1038671-2023-02182. POSTOPERATIVE DIAGNOSIS: POST-OP DIAGNOSIS: PAIN DUE TO HIP JOINT PROSTHESIS, INITIAL ENCOUNTER, LOCALIZED SWELLING, MASS AND LUMP, LOWER LIMB, LEFT. REVISED TO COMPETITOR¿S DEVICES. IT WAS NOTED THAT THE TIBIAL COMPONENT WAS WELL FIXED BUT EASILY SEPARATED FROM THE BONE CEMENT INTERFACE. NOTED THAT THE FEMORAL COMPONENT WAS LOOSE. THE PATELLA WAS ALSO ASSESSED, AND IT WAS FELT THAT WHILE THE PATELLA WAS THIN, THERE WAS SIGNIFICANT POLY WEAR TO THE PATELLAR COMPONENT AND REVISION WAS NECESSARY. A SOFT COMPRESSION DRESSING WAS APPLIED, AND A KNEE IMMOBILIZER WAS PLACED. DISPOSITION: PLAN FOR PACU - HEMODYNAMICALLY STABLE. CONDITION: STABLE. 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

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

  MAUDE report 19580452 ↗
• InjuryJun 19, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST INITIAL LEFT TKA, THE 63 Y/O FEMALE PATIENT HAD A REVISION DUE TO PAIN AND A FLEXION CONTRACTURE. SURGEON PERFORMED THE INDEX SURGERY IN 2015, THE PATIENT WAS COMPLAINING ABOUT PAIN AND A FLEXION CONTRACTURE. SURGEON'S PLAN WAS TO PERFORM A POLY SWAP HOWEVER HE DID NOT BELIEVE THAT ALONE WOULD HELP WITH THE FLEXION CONTRACTURE. CONCURRENTLY, HE TESTED THE FEMUR TO MAKE SURE IT WAS WELL FIXED AND THE COMPONENT JUST FELL OFF OF THE CEMENT. IT LOOKS AS THOUGH THE CEMENT INTERFACE HAD FAILED TO HOLD ONTO THE FEMORAL PROSTHESIS. THERE WAS NO NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Pain

  MAUDE report 17153428 ↗
• InjuryJun 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2016. THIS CASE WAS SCHEDULED AS JUST A POLY EXCHANGE DUE TO THE RECALL. ONCE THE SURGEON DISSECTED DOWN HE REALIZED THE FEMUR WAS FALLING OFF AND THERE WAS LOTS OF OSTEOLYSIS, SO HE REVISED TO COMPETITOR'S DEVICES. 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: Failure of Implant; Osteolysis

  MAUDE report 17073193 ↗
• InjuryFeb 15, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2013, PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERIES. AFTER PATIENT¿S RIGHT KNEE REVISION, HER LEFT KNEE BEGAN TO HURT. ON (B)(6) 2023, PATIENT HAD HER LEFT KNEE EVALUATED BY AN ORTHOPEDIC SURGEON. X-RAYS PERFORMED AS A PART OF THAT EVALUATION REVEALED OSTEOLYSIS. PATIENT IS CURRENTLY IN THE PROCESS OF SCHEDULING A REVISION SURGERY FOR HER LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 16382160 ↗
• InjuryDec 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TEN YEARS POST INITIAL LEFT SIDE TKA, THE 67 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A LOOSE FEMUR. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. PHOTO AND X-RAY RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE DUE TO CHAIN OF COMMAND. NO OTHER PATIENT INFORMATION PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16071394 ↗
• InjuryJan 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, A (B)(6) FEMALE PATIENT COMPLAINED OF HAVING PAIN. FEMUR WAS LOOSE. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13159906 ↗

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