Optetrak Logic 02-012-45-4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862004024), received between Feb 2, 2022 and Apr 14, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 PAIN, BONE SCANS SUGGESTED LOOSENING, NO SIGNS OF INFECTION. AS A RESULT, APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE REVISION OPERATIVE REPORT STATED, THERE WAS A ¿LITTLE BIT OF OVERGROWTH OF SOFT TISSUE OVER THE PATELLA, BUT OTHERWISE IN GOOD CONDITION¿THERE WERE NO SIGNS OF INFECTION¿ WE THEN BEGAN TO LOOK AT THE IMPLANTS AND PROBING AROUND THE FEMUR. THE BONE WAS EXTREMELY SOFT ON THE LATERAL ASPECT WHERE HE WAS 17 AND AFTER FURTHER INVESTIGATION FOUND THAT THERE WAS SOME LOOSENING ON THIS FEMORAL IMPLANT.¿ THE PATIENT¿S POSTOPERATIVE DIAGNOSIS WAS ¿LOOSENING OF TIBIAL AND FEMORAL COMPONENTS DUE TO OSTEOPENIC BONE.¿ WEAR WAS NOT REPORTED FOR THE TIBIAL INSERT IN THE OPERATIVE REPORT. 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 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis; Pain

  MAUDE report 24873548 ↗
• InjuryApr 21, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, JOINT LAXITY, PAIN, AND SWELLING/EDEMA. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21872613 ↗
• InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; 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, 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: Osteolysis; Pain

  MAUDE report 21397985 ↗
• InjuryFeb 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS AND LIMITED ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES SUCH AS WALKING AND STANDING. 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; Failure of Implant; Osteolysis; Pain

  MAUDE report 21315902 ↗
• InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 75 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ANTERIOR KNEE PAIN, FRAGMENTED PATELLA, LOOSE AND SOME CEMENT PARTICLE, TIBIA LOOSENING, PROSTHESIS WEAR, BONE SHEDDING DEBRIS, OSTEOLYSIS, UNSPECIFIED TISSUE INJURY, JOINT LAXITY, SWELLING/ EDEMA, SYNOVITIS, PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES WILL BE RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Shedding Debris; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 21230291 ↗
• InjuryDec 27, 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 ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PROSTHESIS WEAR, LOOSENING, SCAR TISSUE, OSTEOLYSIS, IMPLANT PAIN AND FAILURE OF IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED LEFT TOTAL KNEE. THERE WAS EXTENSIVE ARTHROFIBROSIS AND OSTEOLYTIC DEBRIS PRESENT. AN EXTENSIVE SYNOVECTOMY WAS PERFORMED FREEING THE MEDIAL AND LATERAL GUTTERS. AN EXTENSIVE SOFT TISSUE SLEEVE WAS RAISED OFF THE MEDIAL TIBIA. THE PATELLA BUTTON WAS INSPECTED. IT APPEARED WELL FIXED. THERE WAS A MODERATE AMOUNT OF PLASTIC LOSS NOTED MEDIALLY. THE POLYETHYLENE INSERT SEPARATING THE TIBIA AND THE FEMUR WAS THEN REMOVED. THERE WAS BURNISHING AND WEAR NOTED MEDIALLY AND LATERALLY. PATIENT AWAKENED, RETURNED FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21026934 ↗
• InjuryDec 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, TISSUE BREAKDOWN, SYNOVITIS, OSTEOLYSIS, AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Synovitis; Tissue Breakdown

  MAUDE report 20891767 ↗
• 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 APPROXIMATELY 101 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, ASEPTIC LOOSENING AND DEBONDING OF THE FEMORAL COMPONENT, DAILY KNEE PAIN AND DISCOMFORT, LIMITED DAILY ACTIVITIES AND IMPACTED QUALITY OF LIFE. 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; Discomfort; Osteolysis; Pain

  MAUDE report 20782608 ↗
• InjurySep 4, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE- USA. PATIENT ID: (B)(6). THIS PATIENT HAS A VERIFIED RIGHT KNEE REPLACEMENT ON THE MASTER LIST WITH (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. SERIAL NUMBER ITEM NUMBER AND FULL DESCRIPTION: (B)(6) 02-012-49-4013 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K111400. CONCOMITANTS: (B)(6) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. (B)(6) 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM.

  Patient problems: Discomfort; Pain; Synovitis

  MAUDE report 20138479 ↗
• InjuryJun 18, 2024Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 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, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, SYNOVITIS, INTACT CEMENT MANTLE, CONSTRAINED LINER REVISION, IMPLANT-INTERFACE DEBONDING, PATELLAR RESURFACING, AND VARUS SUBSIDENCE OF THE TIBIAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Insufficient Information; Joint Laxity; Loss of Range of Motion; Swelling/ Edema; Synovitis

  MAUDE report 19559519 ↗
• InjuryMay 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 72-YEAR-OLD PATIENT HAD A LEFT TKA ON (B)(6) 2016. THE PATIENT PRESENTED WITH LUCENCY ON (B)(6) 2024. LUCENCY DISCOVERED UNDERNEATH MEDIAL TIBIAL PLATEAU, LATERAL FEMORAL CONDYLE AND MEDIAL FEMORAL CONDYLE. THE ACTION TAKEN IS OTHER - REVIEW IN 6 MONTHS, OR EARLIER IF SUBJECT BECOMES SYMPTOMATIC AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CASE REPORT FORM DOES NOT INDICATE WHETHER THIS EVENT IS RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT IS RELATED TO CASE(B)(4) AND WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Insufficient Information; Osteolysis; Swelling/ Edema

  MAUDE report 19316304 ↗
• InjuryMar 14, 2023Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 52 YO WHITE FEMALE PATIENT EXPERIENCED (TIBIAL IMPLANT SUBSIDENCE/MIGRATION) TKA TIBIAL COMP LOOSENING / SUBSIDENCE AND ASSOCIATED VARUS DEFORMITY. THE DATE OF ONSET IS (B)(6) 2022. THE PATIENT UNDERWENT REVISION SURGERY. INDICATION FOR REVISION SURGERY IS ASEPTIC, LOOSENING. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 16541954 ↗
• InjuryFeb 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FOUR YEARS POST INITIAL TKA, THIS (B)(6) FEMALE PATIENT EXPERIENCED ASEPTIC TIBIAL LOOSENING. PATIENT CAME IN WITH INCREASED PAIN. X-RAYS SHOW LOOSENING OF TIBIAL COMPONENT WITH MEDIAL & POSTERIOR SUBSIDENCE AND LUCENCY AROUND COMPONENT. ON (B)(6) 2021, PATIENT SAW SURGEON AND KNEE WAS ASPIRATED AND SENT FOR CULTURES. ON (B)(6) 2021, IT'S CONCLUDED NEGATIVE FOR INFECTION. A REVISION WAS DONE ON (B)(6) 2021 USING SMITH-NEPHEW PRODUCTS. THE EVENT IS UNLIKELY RELATED TO THE DEVICE BUY DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13426763 ↗