LOGIC CR TIB INSERT STD, SZ 3, 13MM

Additional Manufacturer Narrative

CONCOMITANTS: (B)(6) 02-012-47-3013 - LOGIC CR TIB INSERT STD, SZ 3, 13MM. (B)(6) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T. (B)(6) 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T. (B)(6) 02-010-03-0230 - LOGIC CR FEMORAL CEM, LEFT, SZ 3. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL K-0021-2022. HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem

LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH). RELATED (B)(4) RK. IT WAS REPORTED THAT APPROXIMATELY 132 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PLAINTIFF HAS SUFFERED FROM PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND INSTABILITY WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S PHYSICAL MOBILITY AND QUALITY OF LIFE. PLAINTIFF REQUIRED A LEFT TOTAL KNEE REVISION SURGERY ON (B)(6) 2023. PLAINTIFF WENT ON TO ENDURE FURTHER PAIN DURING THE RECUPERATION PERIOD AND REQUIRED PHYSICAL THERAPY. PLAINTIFF'S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN CONSEQUENTLY LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.