REFOBACIN BONE CEMENT R 1X40-3
Report
- Report Number
- 3006946279-2021-00134
- Event Type
- Death
- Date Received
- August 19, 2021
- Date of Event
- July 30, 2021
- Report Date
- August 18, 2022
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- LOD
- UDI-DI
- 04040029922569
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS A COMBINATION PRODUCT. (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECT INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED : B4, B7, D9, G3, G6, H2, H6 AND H10. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: A3 AND D5. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. PATIENT MEDICAL RECORD HAS BEEN RECEIVED. IT HAS BEEN FOUND THAT PATIENT HAD THE THREE FOLLOWING AGGRAVING FACTORS: HYPERTENSION, DYSLIPIDEMIA AND NON-INSULIN-DEPENDENT DIABETES. THE IFU OF THE PRODUCT HAS BEEN REVIEWED AND IT WAS FOUND THAT AFTER PREPARATION OF THE PROSTHESIS BED OR DIRECTLY AFTER THE IMPLANTATION OF THE CEMENT AND PROSTHESIS, PRESSURE RISE IN THE MEDULLARY CANAL, WHICH MAY CAUSE A TEMPORARY FALL IN BLOOD PRESURE, RESULTING IN CARDIAC ARREST WITH POTENTIALLY FATAL CONSEQUENCES IN RARE CASES. 1 OTHER COMPLAINT ON PATIENT DEATH FOLLOWING BONE CEMENT IMPLANTATION SYNDROM WAS RECORDED ON THE BATCH SINCE EVER, AND 2 OTHER COMPLAINTS ON PATIENT DEATH FOLLOWING BONE CEMENT IMPLANTATION SYNDROM WERE RECORDED FROM (B)(6), 2018 TO (B)(6), 2021. PLEASE NOTE THAT ALL EVENTS OCCURRED AT THE SAME HOSPITAL. NO NON CONFORMITY WAS FOUND ON THE REFERENCE AND BATCH NUMBER. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT FROM THE SAME BATCH NUMBER AND RETAINED BY THE HOSPITAL HAS BEEN RECEIVED FOR ANALYSIS. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WAS NOT RETURNED OR PICTURES NOT PROVIDED. DEVICE EVALUATION COULD NOT BE PERFORMED. A SAMPLE OF THE AFFECTED BATCH WAS RETURNED FROM THE HOSPITAL, AND HAS BEEN TESTED IN THE LABORATORY UNDER STANDARDIZED CONDITIONS. NO UNUSUAL BEHAVIOR DURING MIXING, HANDLING OR SETTING. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THIS DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE REVIEWED AND SHOW THAT THE PATIENT HAD THE THREE FOLLOWING AGGRIEVING FACTORS: HYPERTENSION, DYSLIPIDEMIA AND NON-INSULIN-DEPENDENT DIABETES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. 1 OTHER COMPLAINT ON PATIENT DEATH FOLLOWING BONE CEMENT IMPLANTATION SYNDROM WAS RECORDED ON THE BATCH SINCE EVER, AND 2 OTHER COMPLAINTS ON PATIENT DEATH FOLLOWING BONE CEMENT IMPLANTATION SYNDROM WAS RECORDED FROM (B)(6) 2018 TO (B)(6) 2021. PLEASE NOTE THAT ALL EVENTS OCCURRED AT THE SAME HOSPITAL. NO NON CONFORMITY WAS FOUND ON THE REFERENCE AND BATCH NUMBER. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT ON (B)(6), 2021 MORNING A PATIENT UNDERWENT A SURGERY TO IMPLANT AN AVENIR STEM. THE 86-YEAR-OLD PATIENT WITH A HISTORY OF STROKE SUFFERED A CEMENT SHOCK WHEN INTRODUCING REFOBACIN CEMENT INTO THE FEMORAL SHAFT. THE PATIENT WENT INTO CARDIAC ARREST ON THE TABLE, FORCING THE ANESTHETISTS TO PERFORM CARDIAC MASSAGE AND THEN SEVERAL SHOCKINGS TO TRY TO RESUSCITATE HER. IN THE END, IT SEEMED TO END WELL AS THE PATIENT WAS THEN REFERRED (AFTER CLOSING THE INCISION) TO THE INTENSIVE CARE UNIT. WE RECEIVED THE INFORMATION THAT THE PATIENT DIED IN THE AFTERNOON.
IT WAS REPORTED THAT ON (B)(6), 2021 MORNING A PATIENT UNDERWENT A SURGERY TO IMPLANT AN AVENIR STEM. THE 86-YEAR-OLD PATIENT WITH A HISTORY OF STROKE SUFFERED A CEMENT SHOCK WHEN INTRODUCING REFOBACIN CEMENT INTO THE FEMORAL SHAFT. THE PATIENT WENT INTO CARDIAC ARREST ON THE TABLE, FORCING THE ANESTHETISTS TO PERFORM CARDIAC MASSAGE AND THEN SEVERAL SHOCKINGS TO TRY TO RESUSCITATE HER. IN THE END, IT SEEMED TO END WELL AS THE PATIENT WAS THEN REFERRED (AFTER CLOSING THE INCISION) TO THE INTENSIVE CARE UNIT. WE RECEIVED THE INFORMATION THAT THE PATIENT DIED IN THE AFTERNOON.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT ON 30.07 MORNING A PATIENT UNDERWENT A SURGERY TO IMPLANT AN AVENIR STEM. THE 86-YEAR-OLD PATIENT WITH A HISTORY OF STROKE SUFFERED A CEMENT SHOCK WHEN INTRODUCING REFOBACIN CEMENT INTO THE FEMORAL SHAFT. THE PATIENT WENT INTO CARDIAC ARREST ON THE TABLE, FORCING THE ANESTHETISTS TO PERFORM CARDIAC MASSAGE AND THEN SEVERAL SHOCKINGS TO TRY TO RESUSCITATE HER. IN THE END, IT ENDED WELL AS THE PATIENT WAS THEN REFERRED (AFTER CLOSING THE INCISION) TO THE INTENSIVE CARE UNIT. WE RECEIVED THE INFORMATION THAT THE PATIENT DIED IN THE AFTERNOON.
THIS IS A COMBINATION PRODUCT (B)(4). REPORT SOURCE, FOREIGN AND HEALTH PROFESSIONAL - EVENT OCCURRED IN (B)(6). THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
IT WAS REPORTED THAT ON 30.07 MORNING A PATIENT UNDERWENT A SURGERY TO IMPLANT AN AVENIR STEM. THE (B)(6) PATIENT WITH A HISTORY OF STROKE SUFFERED A CEMENT SHOCK WHEN INTRODUCING REFOBACIN CEMENT INTO THE FEMORAL SHAFT. THE PATIENT WENT INTO CARDIAC ARREST ON THE TABLE, FORCING THE ANESTHETISTS TO PERFORM CARDIAC MASSAGE AND THEN SEVERAL SHOCKINGS TO TRY TO RESUSCITATE HER. IN THE END, IT ENDED WELL AS THE PATIENT WAS THEN REFERRED (AFTER CLOSING THE INCISION) TO THE INTENSIVE CARE UNIT. WE RECEIVED THE INFORMATION THAT THE PATIENT DIED IN THE AFTERNOON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238155 | REFOBACIN BONE CEMENT R 1X40-3 | ORTHOPAEDIC CEMENT, MEDICATED | LOD | BIOMET FRANCE S.A.R.L. | Z20BAD1401 | 04040029922569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Death |