PHYSICA KR FEMUR COMP.RIGHT #6
Report
- Report Number
- 3008021110-2022-00106
- Event Type
- Injury
- Date Received
- October 21, 2022
- Date of Event
- September 13, 2022
- Report Date
- February 13, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- HRY
- PMA / PMN Number
- K141934
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE COUPLING BETWEEN PHYSICA KR FEMORAL COMPONENT AND PHYSICA CR TIBIAL COMPONENTS IS OFF LABEL. THE MANUFACTURING CHARTS OF THE INVOLVED DEVICES WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY ON THE 19 PHYSICA KR FEMUR COMP.RIGHT #6 THAT BELONG TO PRODUCT CODE 6511.09.160, LOT NUMBER 19AS0MH, STERILIZATION 1900410. NO PRE-EXISTING ANOMALY ON THE 45 PHYSICA FIXED TIBIAL PLATE #7 THAT BELONG TO PRODUCT CODE 6522.15.070, LOT NUMBER 2200092, STERILIZATION 2200057. NO PRE-EXISTING ANOMALY ON THE 14 PHYSICA CR TIBIAL LINER #7 THAT BELONG TO PRODUCT CODE 6533.50.710, LOT NUMBER 21AT07X, STERILIZATION 2100324. NO PRE-EXISTING ANOMALY ON THE 56 PHYSICA TIBIAL STEM L.20MM THAT BELONG TO PRODUCT CODE 6590.15.020, LOT NUMBER 2116090, STERILIZATION 2100286. WE WILL SUBMIT A FINAL REPORT AFTER THE CONCLUSION OF THE INVESTIGATION. ACCORDING TO THE FDA COMMUNICATION RECEIVED ON OCTOBER 13TH 2022 BY EMAIL, THIS REPORT WAS DELAYED DUE TO THE ENROLLMENT PROCESS.
INVESTIGATION: THE COUPLING BETWEEN PHYSICA KR FEMORAL COMPONENT AND PHYSICA CR TIBIAL COMPONENTS IS OFF LABEL. THE MANUFACTURING CHARTS OF THE DEVICES INVOLVED IN THIS EVENT WERE CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS MANUFACTURED WITH THE LOT NUMBERS INVOLVED IN THE EVENT. NO X-RAYS HAVE BEEN GATHERED BY THE COMPLAINT SOURCE. THEREFORE, IT IS IMPOSSIBLE TO EVALUATE THE STATUS OF THE IMPLANT AFTER THE OFF-LABEL COUPLING. BESIDES, THE COMBINATION OF PHYSICA KR AND PHYSICA CR COMPONENTS IS NOT SUPPORTED BY ANY MECHANICAL TEST: THE BALANCING OF THE IMPLANT COULD BE SUB-OPTIMAL, GIVEN THAT THE KINEMATIC OF PHYSICA KR AND PHYSICA CR IS NO LONGER RESPECTED WITH THE COUPLING OF COMPONENTS FROM BOTH FAMILIES. THIS COULD LEAD TO POSSIBLE CONSEQUENCES ON THE IMPLANT GOING FORWARD, NOT EASILY FORESEEABLE. HOWEVER, BASED ON THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE SURGEON WAS PLEASED WITH THE OUTCOME AND PRESCRIBED REHABILITATION TO THE PATIENT. CONCLUSIONS THEREFORE, CONSIDERING THAT: CHECKING THE MANUFACTURING CHARTS OF COMPONENTS INVOLVED IN THIS COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND. THE SURGEON HAS BEEN MADE AWARE ABOUT THE OFF-LABEL COMBINATION AND, DESPITE THIS, BASED ON THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, HE WAS PLEASED WITH THE OUTCOME OF THE SURGERY, AND HE DID NOT BELIEVE A REVISION WAS NECESSARY. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO THE PMS DATA, THE OCCURRENCE RATE OF SIMILAR EVENTS IS AROUND 0,01%. NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR.
SURGERY PERFORMED ON (B)(6) 2022. SURGEON ORIGINALLY ASKED FOR A SIZE 7 CR FEMORAL COMPONENT. THE SALES REPRESENTATIVE GAVE HIM A SIZE 7 CR. UPON OPENING THE PATIENT, THE SURGEON DECIDED A SIZE 6 WOULD BE BETTER. THE SALES REPRESENTATIVE ENTERED THE STERILE OPERATIVE ROOM TO RETRIEVE A SIZE 6 CR. THE SALES REPRESENTATIVE DID NOT REALIZE HE GAVE A SIZE 6 KR FEMORAL COMPONENT TO THE TECHNICIAN. THE SURGEON COMPLETED THE CASE WITH A CR TIBIAL LINER, TIBIAL PLATE, AND TIBIAL STEM. THE SURGEON WAS VERY PLEASED WITH THE PATIENT'S RANGE OF MOTION, TENSION, AND STABILITY. THE SALES REPRESENTATIVE DID NOT NOTICE THAT A KR COMPONENT WAS USED UNTIL COMPLETING THE PAPERWORK AFTER COMPLETION OF THE CASE. THE FOLLOWING IS THE LIST OF THE COMPONENTS INVOLVED: PHYSICA KR FEMUR COMP.RIGHT #6 (PRODUCT CODE 6511.09.160, LOT NUMBER 19AS0MH, STERILIZATION 1900410). PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE 6522.15.070, LOT NUMBER 2200092, STERILIZATION 2200057). PHYSICA CR TIBIAL LINER #7 (PRODUCT CODE 6533.50.710, LOT NUMBER 21AT07X, STERILIZATION 2100324). PHYSICA TIBIAL STEM L.20MM (PRODUCT CODE 6590.15.020, LOT NUMBER 2116090, STERILIZATION 2100286). THE PATIENT IS A MALE, 73 YEARS OLD.
SURGERY PERFORMED ON (B)(6) 2022. SURGEON ORIGINALLY ASKED FOR A SIZE 7 CR FEMORAL COMPONENT. THE SALES REPRESENTATIVE GAVE HIM A SIZE 7 CR. UPON OPENING THE PATIENT, THE SURGEON DECIDED A SIZE 6 WOULD BE BETTER. THE SALES REPRESENTATIVE ENTERED THE STERILE OPERATIVE ROOM TO RETRIEVE A SIZE 6 CR. THE SALES REPRESENTATIVE DID NOT REALIZE HE GAVE A SIZE 6 KR FEMORAL COMPONENT TO THE TECHNICIAN. THE SURGEON COMPLETED THE CASE WITH A CR TIBIAL LINER, TIBIAL PLATE, AND TIBIAL STEM. THE SURGEON WAS VERY PLEASED WITH THE PATIENT'S RANGE OF MOTION, TENSION, AND STABILITY. THE SALES REPRESENTATIVE DID NOT NOTICE THAT A KR COMPONENT WAS USED UNTIL COMPLETING THE PAPERWORK AFTER COMPLETION OF THE CASE. THE LIST OF THE COMPONENTS INVOLVED IS THE FOLLOWING: PHYSICA KR FEMUR COMP.RIGHT #6 (PRODUCT CODE 6511.09.160, LOT NUMBER 19AS0MH, STERILIZATION 1900410). PHYSICA FIXED TIBIAL PLATE #7 (PRODUCT CODE 6522.15.070, LOT NUMBER 2200092, STERILIZATION 2200057). PHYSICA CR TIBIAL LINER #7 (PRODUCT CODE 6533.50.710, LOT NUMBER 21AT07X, STERILIZATION 2100324). PHYSICA TIBIAL STEM L.20MM (PRODUCT CODE 6590.15.020, LOT NUMBER 2116090, STERILIZATION 2100286). THE PATIENT IS A MALE, 73 YEARS OLD. EVENT HAPPENED IN UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1928864 | PHYSICA KR FEMUR COMP.RIGHT #6 | PHYSICA - KR FEMORAL COMPONENT RIGHT #6 | HRY | LIMACORPORATE S.P.A. | 6511.09.160 | 19AS0MH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |