Optetrak Logic 02-010-01-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10885862001252), received between Nov 13, 2019 and Jul 17, 2026 — classified as 57 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (47 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, FOLLOWING THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT BEGAN HAVING COMPLAINTS ABOUT THEIR RIGHT KNEE. FURTHERMORE, THEY LACERATED THEIR RIGHT ACHILLES TENDON AND COMPLETED 6 MONTHS OF PHYSICAL THERAPY. DURING THIS RECOVERY THEY FELT THEIR RIGHT KNEE WAS MORE SWOLLEN AND PAINFUL, AND THEY FELT UNSTABLE WITH DAILY ACTIVITIES. DESPITE NON-OPERATIVE MANAGEMENT, THEIR FUNCTIONAL STATE DECREASED SIGNIFICANTLY DUE TO WORSENING RIGHT KNEE SYMPTOMS. THEY UNDERWENT A CLINICAL, LABORATORY AND RADIOLOGIC WORKUP THAT WAS NEGATIVE FOR INFECTION. APPROXIMATELY 6 YEARS AND 6 MONTHS POST THE INITIAL RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. THE SURGEON NOTED THERE WAS MARKED SYNOVITIS ENCOUNTERED WITH TISSUE CHANGES SUGGESTIVE OF OSTEOLYSIS. THE POLYETHYLENE COMPONENT DEMONSTRATED PITTED WEAR AND SOME EVIDENCE OF OXIDATION WITH YELLOWISH DISCOLORATION GROSSLY VISIBLE. THE FEMORAL COMPONENT WAS FOUND TO E GROSSLY LOOSE AND WAS NOTED TO BE DEBONDED FROM CEMENT IN SEVERAL AREAS, INCLUDING THE ANTERIOR FLANGE AND THE LATERAL DISTAL CONDYLE. THERE WAS EVIDENCE OF DAMAGE TO THE BONY ARCHITECTURE NOTED SECONDARY TO OSTEOLYSIS. LARGE AMOUNTS OF

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain

  MAUDE report 25855124 ↗
• InjuryJul 7, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED POLYETHYLENE WEAR, FEMORAL LOOSENING, OSTEOLYSIS AND SYNOVITIS. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 8 YEARS AND 7 MONTHS AFTER INITIAL IMPLANTATION. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 25734299 ↗
• InjuryJun 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. PER THE OPERATIVE REPORT, THE SURGEON NOTED EXTENSIVE PROLIFERATIVE SYNOVITIS INSIDE THE KNEE. AT THAT TIME, IT WAS NOTED THAT THE FEMORAL COMPONENT WAS COMPLETELY LOOSE, THERE WAS EXTENSIVE WEAR INVOLVING THE LINER, WITH REGARDS TO THE FEMUR THERE WAS EXTENSIVE OSTEOLYSIS, AND THE PATELLA COMPONENT WAS GROSSLY LOOSE.

  Patient problems: Osteolysis; Pain

  MAUDE report 25373168 ↗
• InjuryApr 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED TIBIAL AND PATELLAR POLYETHYLENE WEAR. FEMORAL LOOSENING, OSTEOLYSIS AND SYNOVITIS. AS A RESULT, APPROXIMATELY FOUR YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PATIENT CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING, FOLLOWING THE REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 24772515 ↗
• InjuryMar 22, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT KNEE REVISION PROCEDURE FIVE (5) YEARS AFTER THE INITIAL IMPLANT. THE TIBIAL INSERT COMPONENT WAS EXCHANGED DUE TO PROSTHESIS WEAR. SUBSEQUENTLY, THREE (3) YEARS LATER, THE PATIENT EXPERIENCED PAIN AND SWELLING. AS A RESULT, THE PATIENT UNDERWENT A SECOND (2ND) RIGHT KNEE REVISION PROCEDURE DUE TO PROSTHESIS WEAR. INTRAOPERATIVELY, SYNOVITIS, OSTEOLYSIS AND FEMORAL COMPONENT LOOSENING WAS OBSERVED. THE TIBIAL INSERT COMPONENT WAS EXCHANGED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 24658264 ↗
• InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 3 FOR THIS EVENT: IT WAS REPORTED A PATIENT HAD BILATERAL TOTAL KNEE ARTHROPLASTIES. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE RIGHT KNEE. AS A RESULT, TEN (10) YEARS, SIX (6) MONTHS LATER, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. THE PATIENT WAS DIAGNOSED RIGHT KNEE OSTEOLYSIS CONSISTENT WITH POLYMERIC WEAR AND COMPONENT LOOSENING. INTRAOPERATIVELY, SYNOVITIS, OSTEOLYSIS WERE OBSERVED, THE PATELLA COMPONENT TO BE SOMEWHAT MOBILE AND THE FEMORAL COMPONENT WAS NOTED TO BE DEBONDED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO GURNEY AND BROUGHT TO RECOVERY ROOM IN A STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 24485005 ↗
• InjuryMar 12, 2025Mechanical 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 APPROXIMATELY 95 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FEMORAL DEBONDING, OSTEOLYSIS, AND INSTABILITY. 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; Implant Pain; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21586655 ↗
• InjuryMar 7, 2025Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS FRACTURE, PROTHESIS WEAR, DISCOMFORT, DISTRESS, PAIN AND SCAR TISSUE. 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; Discomfort; Distress; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21549111 ↗
• InjuryMar 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND OSTEOLYSIS OF THE FEMORAL COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE SURGEON PERFORMED A REVISION OF THE TIBIAL POLYETHYLENE AND FEMORAL COMPONENT. THERE WERE NO SURGICAL COMPLICATIONS; HOWEVER, AT THE END OF THE CASE DURING CLOSURE, THE PATIENT WENT INTO CARDIOPULMONARY ARREST. THE PATIENT WAS KEPT INTUBATED AND TAKEN CARE OF BY ANESTHESIA FOR TRANSFER BY SQUAD. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest; Osteolysis

  MAUDE report 21526560 ↗
• InjuryFeb 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SWELLING, SYNOVITIS AND LOOSENING OF THE FEMORAL AND PROSTHESIS WEAR. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED FAILED LOOSE RIGHT TOTAL KNEE, SEVERE OSTEOLYSIS WITH COMPLETE LOSS OF THE POSTERIOR FEMORAL CONDYLES AND SIGNIFICANT LOSS IN THE PROXIMAL TIBIA. PATIENT'S FEMORAL COMPONENT WAS LOOSE AND ADVANCED OSTEOLYSIS PRESENT FROM POLYETHYLENE WEAR. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21458640 ↗
• 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 21396929 ↗
• InjuryFeb 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS AND 7 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A LOOSE FEMUR WITH A PATELLA EXCHANGE. THE PATIENT WAS REVISED TO A CONSTRAINED FEMUR AND LINER. 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 21294687 ↗
• InjuryJan 27, 2025Mechanical 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 110 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, LOSS OF RANGE OF MOTION, OSTEOLYSIS, PAIN, SWELLING/EDEMA, AND SYNOVITIS. 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21246466 ↗
• InjuryJan 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS, DISCOMFORT, PAIN AND SYNOVITIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21169661 ↗
• InjuryJan 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 30 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, CHRONIC PROGRESSIVE PAIN, INCREASING ONGOING SWELLING, FREQUENT CLICKING AND GRINDING, OCCASIONAL LOCKING AND GIVING OUT OF THE KNEE, WORSENING PAIN WITH ACTIVITY, TWISTING OR CHANGING DIRECTION, ARISING FROM A SITTING TO STANDING POSITION, AND GOING UP OR DOWN THE STAIRS, DIFFICULTY WALKING AND BENDING, AND INCREASING DIFFICULTY PERFORMING ACTIVITIES OF DAILY LIVING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21104517 ↗
• InjuryDec 27, 2024Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 99 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, LOSS OF RANGE OF MOTION, MUSCLE/TENDON DAMAGE, OSTEOLYSIS, PAIN, SCAR TISSUE, SWELLING AND SYNOVITIS. 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; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21026457 ↗
• InjuryDec 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION A 61 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO A FAILED RIGHT KNEE ARTHROPLASTY. 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 REC'D 21 APR 2023. THERE WAS FOUND TO BE CLEAR SYNOVIAL JOINT FLUID. THERE WAS FOUND TO BE VISIBLE POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS A GROSSLY LOOSE FEMORAL COMPONENT FROM THE CEMENT MANTLE. THERE WAS A SEVERE SYNOVIAL REACTION AND COMPLETE SYNOVECTOMY WAS PERFORMED. THERE WAS A PARTIALLY FIXED TIBIAL COMPONENT. THERE WAS MODERATE OSTEOLYSIS AROUND THE CEMENT OF THE FEMORAL COMPONENT AND MODERATE OSTEOLYSIS AT THE PROXIMAL TIBIA. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS.

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

  MAUDE report 21022539 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 118 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, 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: Failure of Implant; Osteolysis; Pain

  MAUDE report 20906721 ↗
• InjuryNov 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SWELLING/EDEMA, IMPLANT PAIN, SYNOVITIS, AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20796702 ↗
• InjuryNov 20, 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 ARTHROPLASTY ON (B)(6) 2014, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT DUE TO EXTENSIVE OSTEOLYSIS AND LARGE CYST FORMATION OF THE MEDIAL FEMORAL CONDYLE AND POLY WEAR. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 20734582 ↗
• InjuryNov 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, BALANCE PROBLEMS, AMBULATION DIFFICULTIES, DISCOMFORT, PAIN, SYNOVITIS 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 20688318 ↗
• InjuryNov 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 13 YEARS AND 4 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE."

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

  MAUDE report 20625274 ↗
• InjuryNov 5, 2024Unstable; 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 TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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

  MAUDE report 20611921 ↗
• InjuryOct 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4)). PATIENT ID: (B)(6). 10/11/2024: ADDITIONAL INFORMATION RECEIVED IN INBOX ON 10/11/2024. ATTACHED EMAIL AND REVISION OP REPORT. REVISION SURGERY OPERATIVE NOTED WERE PROVIDED. PREOPERATIVE DIAGNOSIS: RIGHT FAILED PAINFUL TOTAL KNEE REPLACEMENT. POSTOPERATIVE DIAGNOSIS: RIGHT FAILED PAINFUL TOTAL KNEE REPLACEMENT PLUS FEMORAL OSTEOLYSIS OF THE MEDIAL POSTERIOR AND LATERAL CONDYLE, GROSSLY LOOSE FEMORAL COMPONENT, ADVANCED WEAR OF THE PATELLA, POLYETHYLENE ON THE TIBIAL INSERT WITH DELAMINATION. INDICATION: THE PATIENT IS A 59-YEAR-OLD MALE WHO HAS BEEN SUFFERING WITH RECURRENT EFFUSIONS, PAIN AND STIFFNESS. THE PREVIOUS X-RAYS AND MRI DEMONSTRATED OSTEOLYSIS WITH LOOSENING OF THE FEMORAL COMPONENT. DESCRIPTION OF THE PROCEDURE: THERE WAS LATERAL WEAR OF THE PATELLA BUTTON. THE PATELLAR BUTTON WAS WELL FIXED. ELECTROCAUTERY WAS USED TO CLEAN THE FIBROSIS FROM THE MARGIN OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT APPEARED TO BE GROSSLY LOOSE. A RECIPROCATING SAW WAS USED TO BREAK THE INTERFACE BETWEEN THE IMPLANT AND THE CEMENT. AT THIS POINT, THE FEMORAL IMPLANT WAS TAPPED OUT WITH COMPLETE DEBONDING OF THE CEMENT AND THE IMPLANT. THERE

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 20514103 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 105 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EXTREMITY SWELLING, DISCOMFORT; SYNOVITIS, TUMOR-LIKE GROWTH, MILD POLY WEAR AND DELAMINATION ON THE TIBIAL INSERT, LOOSE/DEBONDING FEMORAL. 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Discomfort; Inadequate Osseointegration; Swelling/ Edema; Synovitis

  MAUDE report 20422854 ↗

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