OPTIPAC 60 REFOBACIN BONE CEMENT R-3
Report
- Report Number
- 3006946279-2022-00010
- Event Type
- Injury
- Date Received
- January 28, 2022
- Date of Event
- April 9, 2019
- Report Date
- February 18, 2022
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- MBB
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS A COMBINATION PRODUCT. (B)(4). CONCOMITANT MEDICAL PRODUCTS - LIST OF ASSOCIATED DEVICES: PSN ASF CR 10MM PLY L 7-12 GH, REFERENCE 42-5110-006-10, BATCH 63561707A17. PSN ALL POLY PAT PLY 32MM, REFERENCE 42-5400-000-32, BATCH 64173391I18. PSN TIB STM 5 DEG SZ G L, REFERENCE 42-5320-079-01, BATCH 63931138B18. PSN FEM CR CMT CCR STD SZ 9 L, REFERENCE 42-5026-066-01, BATCH 63487999I16. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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.
THIS IS A COMBINATION PRODUCT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED (X-RAYS, SURGICAL REPORT, PHOTOGRAPHS, LAB TEST). THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. 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. A COMPLAINT EXTRACT WAS DONE REGARDING REVISION DUE TO INFECTION: 1 COMPLAINTS (1 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON OPTIPAC 60 REFOBACIN BONE CEMENT R-3, REFERENCE (B)(4), FROM (B)(6) 2019 TO (B)(6), 2022. 1 COMPLAINTS (1 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON OPTIPAC 60 REFOBACIN BONE CEMENT R-3, REFERENCE (B)(4), BATCH 824DA09185. THE IFU HAS BEEN REVIEWED AND IT IS STATED THAT PATIENTS SHOULD BE WARNED OF THE IMPACT OF EXCESSIVE LOADING THAT CAN RESULT IF THE PATIENT IS INVOLVED IN AN OCCUPATION THAT INCLUDES SUBSTANTIAL WALKING, RUNNING, LIFTING OR EXCESSIVE MUSCLE LOADING DUE TO WEIGHT THAT PLACES EXTREME DEMANDS ON THE JOINT AND CAN RESULT IN DEVICE FAILURE OR DISLOCATION. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS TRACED TO NON-DEVICE RELATED FACTORS. INDEED, THE PATIENT WAS VERY ACTIVE AND MANAGED TO DO SPINNING ONLY A FEW DAYS AFTER PRIMARY SURGERY, DUE TO THIS AN ACUTE WOUND RUPTURE OCCURRED, AND THE CHANGE OF LINER AND WOUND DEBRIDEMENT WAS PERFORMED. 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 THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2019 DATE DUE TO DEEP INFECTION.
IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2019 DATE DUE TO DEEP INFECTION. THE PATIENT WAS VERY ACTIVE AND MANAGED TO DO SPINNING ONLY A FEW DAYS AFTER PRIMARY SURGERY, DUE TO THIS AN ACUTE WOUND RUPTURE OCCURRED, AND THE CHANGE OF LINER AND WOUND DEBRIDEMENT WAS PERFORMED. PATIENT DID NOT ADHERE TO REHABILITATION PROTOCOL FOLLOWING INITIAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46385 | OPTIPAC 60 REFOBACIN BONE CEMENT R-3 | BONE CEMENT, ANTIBIOTIC | MBB | BIOMET FRANCE S.A.R.L. | 824DA09185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | ASSOCIATED DEVICES LISTED IN H10. |