LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

Additional Manufacturer Narrative

H6: CORRECTED HEALTH EFFECT CLINICAL CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE NOT PROVIDED.

Description of Event or Problem

LEGAL CASE - USA. IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CONCOMITANT PRODUCTS: 4136622 - 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4. 4165214 - 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4. 3663372 - 02-012-35-4009 - LOGIC TIBIA PS MOD INSRT SZ 4 9MM. 2928146 - 02-012-41-1010 - LOGIC TIBIA TRAPTRAY CEM SZ 1F/1T. 4040341 - 02-012-41-4030 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/3T. 4195256 - 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T. (B)(6) - 02-012-44-2013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. (B)(6) - 02-012-44-4009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 4188754 - 142-28-00 - COCR FEM HEAD 28MM +0 OFFSET 12/14. 4160946 - 160-31-15 - PF SPLINE PLASMA W/HA EXT OFFSET SZ 15. 4168429 - 200-02-32 - THREE PEG PATELLA 32MM. 4200097 - 200-02-35 - THREE PEG PATELLA 35MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-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.